Full issue

November 2024 volume 31 issue 4

Testing the In Vitro Product Performance of Inhalation and Nasal Drug Products: Views of the USP Expert Panel

While inhalation and nasal drug products are available as various different drug-device combination products for the treatments of local and systemic diseases, their compendial performance testing has concerned with only delivered dose uniformity (DDU) and aerodynamic... Full article

Masahiro Sakagami1,2 Nikoletta Fotaki1,3
1USP Expert Panel on New Advancements in Product Performance Testing (EP-NAPPT).
2Department of Pharmacy and Pharmacology, Centre for Therapeutic Innovation, University of Bath, Bath, UK.
3Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, VA, USA.
Demonstrating Discriminatory Power of a Dissolution Method Using DDDPlus: Case Study of an Extended-Release Formulation and Use in Regulatory Justifications

Dissolution testing is an important attribute that provides insight into in vivo performance, batch-tobatch uniformity and consistent clinical quality. Demonstrating discriminatory power of the dissolution method ensures that any changes in manufacturing processes or... Full article

Sivacharan Kollipara1 Adithya Karthik Bhattiprolu1 Rajkumar Boddu1 Mahendra Chougule1 Paramita Saha1 Tausif Ahmed1
1Biopharmaceutics Group, Global Clinical Management, Dr. Reddy’s Laboratories Ltd., Integrated Product Development Organization, Hyderabad, Telangana, India.
Mathematical Model Application for In Vitro Release Kinetics of Ranolazine Extended-Release Tablets

Mathematical models are vital tools in understanding drug release mechanisms and release kinetics of different dosage forms, which can be achieved by assessing dissolution release profiles. This study aimed to determine and compare the mechanism of drug release using... Full article

Sunil Chowdary Koduri1 Ayyakannu Arumugam Napoleon1
1Department of Chemistry, Pharmaceutical Chemistry Division, School of Advanced Sciences, Vellore Institute of Technology, Vellore, Tamil Nadu, India
Comparative In Vitro Release of Eletriptan Hydrobromide Formulations for Buccal Administration

Migraine is a neurological disease characterized by unilateral headache attacks that can last between 4-72 hours and accompanying different symptoms such as photophobia, phonophobia, osmophobia, nausea, vomiting, or movement sensitivity. Eletriptan hydrobromide (EHBR) has been recognized as... Full article

Simge Ararat1 Meliha GÜneş2 Sinem Yaprak Karavana2
1Institute of Health Science, Master Program of Pharmaceutical Technology, Ege University, Bornova, Izmir, Türkiye.
2Department of Pharmaceutical Technology, Faculty of Pharmacy, Ege University, Bornova, Izmir, Türkiye.
In Vitro Performance of Commercially Available Glimepiride Tablets in Indonesia

Glimepiride is a commonly prescribed medication for diabetes mellitus that is available in both generic and innovator products. Although the performance of individual products varies, generics should meet quality standards of bioequivalence with the innovator. This study aimed to evaluate... Full article

Yulias Ninik Windriyati1 Risha Fillah Fithria2 Ananda Nurunabilah3 Andita Pita Loka3 Zahra Hade Utami3 Feby Noftiyaningsih3
1Department of Pharmaceutic and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Wahid Hasyim, Semarang, Central Java, Indonesia.
2Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Wahid Hasyim, Semarang, Central Java, Indonesia.
3Undergraduate Program, Faculty of Pharmacy, Universitas Wahid Hasyim, Semarang, Central Java, Indonesia.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Logan Instruments appoints Keith Hamman as President and CEO

Somerset, NJ - Logan Instruments Corp. (Logan), a global provider of pharmaceutical formulation development and QC instruments used for studying API drug release characteristics of... Full article

Simulations Plus and the University of Southern California Secure NIH Grant to Develop New AI Drug Discovery Offerings

Partnership will advance the field of ligand-based virtual screening to improve drug design and optimization activities Full article

Simulations Plus Announces New Research Project with International Collaboration on Cosmetics Safety

Objective: Define best practices for use of novel PBK modeling strategies to support animalfree safety assessment of new chemicals Full article

Simulations Plus Releases ADMET Predictor® Version 12

Enhancements in key models power HT-PBPK simulations and AI-driven drug design with unprecedented performance and accuracy Full article


Full issue

August 2024 volume 31 issue 3

In Vitro Product Performance Testing of Oral Drug Products: View of the USP Expert Panel

This is the last in a series of Stimuli articles developed by the USP Expert Panel New Advancements in Product Performance Testing charged with reviewing and proposing new approaches for drug performance testing in the US Pharmacopeia. The USP Expert Panel created working groups that focused on... Full article

Nikoletta Fotaki1 Deirdre D’Arcy2 James Demuth3 Andre Hermans4 Xujin Lu5 Ishai Nir6 Emmanuel Scheubel7 Raymond Skwierczynski8
1Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, UK.
2School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
3University of Wisconsin-Madison, Madison, WI, USA.
4Merck and Co., Inc., Rahway, NJ, USA.
5Bristol-Myers Squibb, New Brunswick, NJ, USA.
6Distek, Inc., North Brunswick, NJ, USA.
7F. Hoffmann-La Roche AG, Basel, Switzerland.
8Skwierczynski Consulting, Andover, MA, USA.
Magnesium Stearate - Its Importance and Potential Impact on Dissolution of Oral Solid Dosage Forms

Magnesium stearate is the most commonly used lubricant in the formulation and manufacture of oral solid dosage forms (compressed tablets and powder-filled capsules). However, its chemical and physical properties can adversely impact the final dosage form by... Full article

R. Christian Moreton1
1FinnBrit Consulting, Waltham, MA, USA.
Dissolution Testing Strategies for Large Sample Sizes and Applications in Continuous Manufacturing

The potential advantages of larger sample sizes for dissolution testing through surrogate modeling in the context of continuous manufacturing and process analytical technology is the motivation for development of a statistically based batch release acceptance criterion. A common approach... Full article

Martin Otava1 Sylvaine Jacquart2 Stan Altan3
1Manufacturing and Applied Statistics, Janssen-Cilag s.r.o., a Johnson & Johnson company, Prague, Czech Republic.
2Dissolution Sciences, Janssen Pharmaceutica NV, a Johnson & Johnson company, Beerse, Belgium.
3Manufacturing and Applied Statistics, Janssen Pharmaceutical LLC, a Johnson & Johnson company, Springhouse, PA, USA
Life Cycle Application of AQbD for Formulation Development and Validation of a Dissolution Method for Nevirapine

Introduction: Dissolution plays a vital role as an in vitro test in the pharmaceutical product life cycle. For the evaluation of an appropriate dissolution test, analytical quality by design (AQbD) principles can provide increased confidence when deciding whether... Full article

Rayza A. D. de Almeida1 Maria Luiza R. A. de Oliveira1 Ivone de J. N. Lopes1 Diogo D. Nascimento1 Camila A. Oliveira1 Livia D. Prado1
1Laboratório de Desenvolvimento e Validação Analítica, Instituto de Tecnologia em Fármacos (Farmanguinhos), Fundação Oswaldo Cruz, Rua Sizenando
Comparative Study of Metformin Hydrochloride Tablets in Argentina

Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Critical quality attributes were evaluated and compared for... Full article

Marta I.V. Brevedan1 María A. Varillas2 Noelia L. Gonzalez Vidal1,2
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Bahía Blanca, Argentina.
Comparative Dissolution Study of Enzalutamide Capsules in India

Introduction: The objective was to conduct a comparative dissolution study of several brands of enzalutamide capsules available in the Indian market using a model-independent approach. Enzalutamide is classified as a Biopharmaceutical Classification System class 2 medicine due to its limited... Full article

Binit Patel1 Ravi Patel2 Shalin Parikh3 Pravinkumar Darji4 Archita Patel5 Dilip Ghava6
1Hovione, East Windsor, NJ, USA.
2Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, Gujarat, India.
3Shree SK Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, Gujarat, India.
4Exemplify Biopharma Inc., Cranbury, NJ, USA.
5Department of Pharmaceutical Chemistry and Analysis, Ramanbhai Patel College of Pharmacy, Charusat University, Changa, Gujarat, India.
6National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad, Gandhinagar, Gujarat, India.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

IDIS Dissolution Data Management Software Enhances Compliance in Automation

The IDIS Tablet Dissolution software provides an open architecture allowing users to control a wide range of dissolution testers, spectrophotometers with unique HPLC automation. New features in newly released V4 provide greater compliance in automation. Full article

Simulations Plus Releases GastroPlus® X, The Next Generation PBPK/PBBM Modeling and Simulation Software

Redesigned platform offers ease-of-use, enhanced software engineering, and significant productivity gains for users Full article

Simulations Plus Acquires Pro-ficiency, Creating a Oneof- a-Kind Platform Spanning the Drug Development Continuum

Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, has announced the acquisition of Pro-ficiency Holdings, Inc. and... Full article

Logan Instruments Launches Innovative Microsphere Release Testing System

According to the SDi Global Assessment Report 2022, Logan Instruments ranked third in the dissolution testing global market. Logan Instruments specializes in pharmaceutical testing equipment, offering a wide range of products including... Full article


Full issue

May 2024 volume 31 issue 2

Impact of Vessel Inner Diameter in USP Dissolution Apparatus 2

Commercially available dissolution vessels used with United States Pharmacopeia (USP) apparatus 1 and 2 typically have nominal inner diameters of 100 or 104 mm. Little data are available in the literature to evaluate whether equivalent dissolution results are obtained when the same product is tested in both types of vessels. This study provides... Full article

David Curran1 Geoffrey Neil Grove2 Manasa Tsundupalli3 Xiaoling Zhang4
1Medicine Development and Supply, GSK, Collegeville, PA, USA.
2Molecular Diagnostics Division, Bio-Techne, Waltham, MA, USA.
3TechOps, Incyte Corporation, Wilmington, DE, USA.
4CMC Regulatory Affairs, GSK, Collegeville, PA, USA.
Application of Salicylic Acid Tablets in the Performance Verification Test for the Flow-Through Cell Apparatus

The flow-through cell is the preferred apparatus for dissolution testing of controlled-release dosage forms, poorly soluble drugs, and many special dosage forms, such as suspensions, soft capsules, implants, microspheres, and liposomes. Although the flow-through cell apparatus has been... Full article

Hua Chen1 Yanhong Qiu2 Jinyuan Gao3 Luni Zhou1 Yu Zhao2 Bo Zheng2,3 Liju Yu1
1Institute for Chemical Drug Control, National Institutes for Food and Drug Control (NIFDC), Beijing, China.
2Scientific & Training Support Department, Nikyang Enterprise Limited, Hong Kong, China.
3R&D Department, Labvo Technology Limited, Hong Kong, China.
Selection and Parameters Affecting Dissolution Media

Dissolution of oral solid dosage forms refers to the process by which active pharmaceutical ingredient(s) are released from the dosage form into a liquid vehicle, called the dissolution medium. Dissolution is an essential test for the development and quality control of almost all dosage forms. The availability of.. Full article

Priyal Jangla1 Roopam Raut1
1Department of Pharmaceutics, Principal K. M. Kundnani College of Pharmacy, Mumbai, India.
Dissolution Test of Patent and Generic Drugs of Metformin Hydrochloride

Type 2 diabetes is a chronic, multifactorial disease with a genetic predisposition caused by a deficit in the action or secretion of insulin, resulting in hyperglycemia, which is characterized by increased blood glucose levels. Metformin hydrochloride is the most frequently used medication. There is a wide.. Full article

América Yazmín Torres-Moreno1 Fred Luque-Ortega1 Adolfo Jesús Torres-Moreno2 Alba Lucero García-Medina3 Sandra García-Medina3
1Basic Sciences Laboratory, Faculty of Dentistry, Universidad Autónoma de Sinaloa, Sinaloa, Mexico.
2Faculty of Medicine, Universidad Autónoma de Sinaloa, Sinaloa, Mexico.
3Laboratory of Biopharmacy Research, Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Unidad Profesional Adolfo López Mateos, Mexico City, Mexico.
Quality Control Parameters of Antihypertensive Medications Marketed in Eastern Ethiopia: Amlodipine Besylate and Enalapril Maleate Tablets

Substandard medications have a negative impact on treatment outcomes. To get the desired therapeutic effect, drugs need to have the required pharmaceutical properties and the right amount of the active pharmaceutical ingredient. Thus, this study aimed to.. Full article

Natanim Degefu1 Melese Getachew2 Wegene Deriba3 Palanimuthu Rajeevkumar1
1Department of Pharmaceutics, School of Pharmacy, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia.
2Department of Pharmacy, College of Medicine and Health Sciences, Debre Markos University, Debre Markos, Ethiopia.
3School of Environmental Health, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia.
Highlights from the 2023 AAPS 360 Annual Meeting - In Vitro Release and Dissolution

The American Association of Pharmaceutical Scientists (AAPS) successfully held its PharmSci 360 Annual Meeting and Exposition event on October 22-25, 2023, at the Orange County Convention Center in Orlando, FL. This year’s meeting was held entirely inperson and did not include a hybrid element, allowing... Full article

Sanjaykumar Patel1 Jie Shen2 Zhao Liu1 Ishai Nir3 Devin Janai Swiner1 Hyunho Kang1 Vivian A. Gray4 Andre Hermans1 Tahseen Mirza5
1Merck & Co., Inc., Rahway, NJ, USA.
2Northeastern University, Boston, MA, USA.
3Distek Inc., New Brunswick, NJ, USA.
4Dissolution Technologies, Hockessin, DE, USA.
5Food and Drug Administration, White Oak, MD, USA.
New USP Dissolution Performance Verification Standard: What, Where, and When

On April 6, 2023, the United States Pharmacopeia (USP) presented a webinar entitled “New USP Dissolution Performance Verification Standard: What, Where, and When.” The webinar was sponsored by the American Association of Pharmaceutical Scientists (AAPS) and AAPS In Vitro Release and Dissolution Testing (IVRDT) Community and... Full article

Sanjaykumar Patel1 Mark Liddell2 Dorys Argelia Diaz3 Brian Crist4 Vivian A. Gray5
1Merck & Co. Inc., Rahway, NJ, USA.
2United States Pharmacopeia, Rockville, MD, USA.
3Global Product Development, Pfizer Inc., Groton, CT, USA.
4DissoAssist Consulting, Wilmington, NC, USA.
5V. A. Gray Consulting, Hockessin, DE, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Logan Instruments Introduces the Electronic Performance Validation Testing Toolset “EPVT-1200 system”

Logan Instruments has developed the “EPVT-1200 system” for USP apparatus 1 and 2 Performance Validation Tests, aimed at revolutionizing the validation process of dissolution testers... Full article

Simulations Plus Extends Collaboration with Major Toxicology Research Agency

Research project with NIEHS includes focus on qualification of in silico methods for prioritization, assessment of risk, and identification of safety margins for chemical use Full article

Simulations Plus and the University of Bath Awarded New FDA Grant

Partnership will produce an enhanced, validated dermal PBBM/PBPK model to inform product development and bioequivalence decisions Full article


Full issue

February 2024 volume 31 issue 1

Advances in Product Quality and Performance Tests for Topical and Transdermal Products: View of the USP Expert Panel

Quality and performance testing of topical and transdermal products encompasses a broad set of product types, test equipment, and unique considerations. This Stimuli article is one in a series of such articles on product testing methods that explore the relevant considerations and identify opportunities for standardization with different types of... Full article

Sam G. Raney1 Sharareh Senemar2 Matt Burke2 Christina Lee1 Jaimin R. Shah2 Kevin S. Li2 Om Anand1 Kevin S. Warner2
1FDA Liaison to the USP New Advancements in Product Performance Testing Expert Panel
2Member of the USP New Advancements in Product Performance Testing Expert Panel
An In Vitro Model for Release of Acetaminophen When an Overdose is Ingested Orally

Acetaminophen (paracetamol) is an analgesic and antipyretic drug that is widely used across the globe due to its efficacy and safety within the therapeutic dose range. When acetaminophen is ingested in amounts higher than the recommended dosage over several days, severe hepatotoxic effects can result. Next to the opioid drugs... Full article

Maja Chronowska1 Jennifer Dressman1
1Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany
The Importance of Dissolution Tests to Evaluate Quality of Dietary Supplements: Case Study of Controlled Release Caffeine Capsules

Controlled-release capsules (named brand I and II) containing caffeine, available on the Brazilian and US market as dietary supplements, were assessed following the criteria described by the United States Pharmacopeia. The capsules were evaluated by average weight, caffeine content, disintegration, and... Full article

Giovana C. Bazzo1 Maria T. França1 Jaqueline Franzen1 Hellen K. Stulzer1
1Innovation Study Center in Pharmaceutical Technologies (NITFar), Department of Pharmaceutical Sciences, Federal University of Santa Catarina, Campus Trindade, Florianópolis, SC, Brazil
Evaluation of a pH-Gradient Biphasic Dissolution Test for Predicting In Vivo Performance of Weakly Basic Drugs

The present study aimed to confirm the biorelevance of the pH-gradient biphasic dissolution model for three ketoconazole (KTZ) formulations with different excipients and establish an in vivo-in vitro correlation (IVIVC). Experiments were performed with a pH-gradient biphasic dissolution model for drug absorption, consisting of... Full article

Jia Deng1,2 Shengying Shi3 Xiaowei Fan3 Lixia Guo1 Jingou Ji3
1Chongqing Key Laboratory of Natural Products, College of Environment and Resources, Chongqing Technology and Business University, Chongqing, China
2Central Nervous System Drug Key Laboratory of Sichuan Province, Luzhou, Sichuan, China
3College of Chemistry and Chemical Engineering, Chongqing University, Chongqing, China. Jia Deng and Shengying Shi contributed equally to this work
Evaluation of Different Methods for Dissolution Profile Similarity Comparison of Montelukast Tablets in Türkiye

This study aimed to evaluate the highly variable in vitro dissolution profiles of generics and innovator montelukast products in the Turkish drug market by comparing model-dependent and model-independent analysis methods. Seven generic montelukast sodium products were tested, labeled G1-G7, and... Full article

Özlem Çoban1 Duygu Yilmaz Usta2 Sıla Gulbag Pinar3
1Department of Pharmaceutical Technology, Karadeniz Technical University, Trabzon, Türkiye
2Department of Pharmaceutical Technology, Gazi University, Ankara, Türkiye
3Department of Pharmaceutical Technology, Suleyman Demirel University, Isparta, Türkiye
In Vitro Characterization of Multi-Source Omeprazole Capsule Dissolution Performance Under Biorelevant Conditions

Regulatory requirements for drugs approval in several countries allow pharmaceutical companies to market drug products after providing evidence of compliance with pharmacopeial quality requirements and good manufacturing practices, a policy that reduces drug treatment cost and increases... Full article

Yessica Imbriago1 Alejandra Schiavo1 Andrés Baptista1 Patricia Rega1 Marianela Lorier1 Pietro Fagiolino1 Cecilia Maldonado1 Marta Vázquez1 Manuel Ibarra1
1Department of Pharmaceutical Sciences, Universidad de la República, Montevideo, Uruguay
Therapeutic Equivalence of Multisource Drugs Assessed by In Vitro Dissolution Studies: Amoxicillin/Clavulanic Acid Tablets

The objective of this study was to determine the in vitro therapeutic equivalence of multisource amoxicillin/clavulanic acid (875 mg/125 mg) tablets to establish their interchangeability with the reference product. Six multisource products manufactured in Peru, Colombia, Argentina, Mexico, and India were... Full article

Victor Chumpitaz-Cerrate1 Luis Moreno-Exebio1 Eliberto Ruiz-Ramirez1 César Franco-Quino1 María Flores-Rodríguez2 Lesly Chávez-Rimache1
1Investigación en Ciencias Básicas Estomatológicas (ICBEST) Group, Universidad Nacional Mayor de San Marcos, Lima, Perú
2Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú
Comparative Dissolution Study of Atorvastatin Calcium Tablets in Indonesia

Atorvastatin calcium is a prescribed medication for hyperlipidemia that is widely used in Indonesia, both the innovator and its generic products. The performance of each product may vary, but generic products must meet quality standards of bioequivalence with the innovator. This study aimed to... Full article

Yulias Ninik Windriyati1 Ibrahim Arifin2 Lailatunnafiah1 Any Farikhah1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Universitas Wahid Hasyim, Indonesia
2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Wahid Hasyim, Indonesiea-.m ail: yninik@unwahas.ac.id
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Logan Instruments Announces Dry Heat Pro Series Dissolution Tester

Logan Instruments Corp. is proud to announce the next evolution in dissolution apparatus 1, 2, 5, and 6 Full article

Simulations Plus Embarks on Collaboration with Northeastern University and The TIM Company Through New FDA Grant

Partnership aims to integrate experimental data and PBPK modeling to identify key formulation factors to accelerate modified-release product development Full article

Simplifying Dissolution Testing: Opt-Diss UV Fiber Optic System Software Rev. 3.20 Delivers Streamlined Processes and Expanded Capabilities

North Brunswick, NJ - Distek, Inc., a well-reputed leader in laboratory pharmaceutical instruments, is excited to announce the release of the latest software update for the Opt-Diss... Full article


Full issue

November 2023 volume 30 issue 4

Testing the In Vitro Product Performance of Mucosal Drug Products: View of the USP Expert Panel

Performance testing of mucosal drug products presents the user with a multitude of challenges. Not only are there many different dosage forms to be distinguished, but also a wide variety of administration routes. The target action effect (local or systemic) is another factor to be considered. Thus, it quickly becomes apparent that there will... Full article

Sandra Klein1 Masahiro Sakagami2 S. Kevin Li3 Kevin Warner4
1Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, Greifswald, Germany.
2Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, VA, USA.
3College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
4Alucent Biomedical, Inc., Salt Lake City, UT, USA.
Comparative Dissolution of Budesonide from Four Commercially Available Products for Oral Administration: Implications for Interchangeablity

Budesonide is a corticosteroid regularly used in oral formulations to treat various inflammatory diseases in the gastrointestinal tract, such as Crohn’s disease and ulcerative colitis. Budesonide has also been formulated to be effective against immunoglobulin A (IgA)-related nephropathy. This study aimed to... Full article

Jennifer Dressman1
1Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt, Germany
Dissolution Performance of Verapamil-HCl Tablets Using USP Apparatus 2 and 4: Prediction of In Vivo Plasma Profiles

This study aimed to examine the in vitro dissolution performance of verapamil-HCl reference tablets using USP apparatus 2 (paddle), apparatus 4 (flow-through cell), and media of physiological relevance, and to estimate plasma levels using a convolution approach. The study used apparatus 2 at... Full article

José R. Medina-López1 Regina Lugo-Ortíz1 Juan M. Contreras-Jiménez1 Marcela Hurtado1 Sally A. Helmy2,3
1Departamento Sistemas Biológicos, Universidad Autónoma Metropolitana-Xochimilco, Mexico City, Mexico.
2Department of Clinical and Hospital Pharmacy, Faculty of Pharmacy, Taibah University, Al-Madinah Al-Munawarah, Saudi Arabia.
3Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.
Preparation and Characterization of a Novel Optimum Modified Liquisolid Compact to Enhance the Dissolution Profile of Mifepristone

Most drugs used to treat vaginal disorders are administered orally or parenterally. Mifepristone (MFP) is a Biopharmaceutical Classification System class IV drug that is currently used to abort pregnancies under 70 days long. To improve bioavailability, a modified liquisolid compact (MLSC) formulation has been... Full article

Riya Patel1 Gayatri Patel1
1Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Anand, Gujarat, India.
Development of In Vitro Dissolution Test Method for Bilastine and Montelukast Fixed-Dose Combination Tablets

Bilastine and montelukast are Biopharmaceutical Classification System (BCS) class II compounds with low bioavailability, especially when taken orally. It is challenging to develop a dissolution test. The purpose of this study is to select an in vitro dissolution test that would be useful for... Full article

Ravi Patel1 Ravisinh Solanki1 Zeeshan Shaikh1 Sanjay Chauhan1 Shalin Parikh2 Binit Patel3
1Department of Quality Assurance, Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, India.
2Analytical Development Division, Senores Pharmaceuticals, Ahmedabad, India.
3Analytical Development Division, Aavis Pharmaceuticals, GA, USA.
Comparison of Rosuvastatin Calcium Tablets Marketed in Saudi Arabia Under Biowaiver Conditions: In Vitro Quality Control Dissolution Study

Rosuvastatin (RST) calcium is used to treat hyperlipidemia, and several generic brands of RST calcium are available in Saudi Arabia along with the innovator. The current study aimed to compare two generic brands of RST with the innovator with respect to physicochemical parameters and... Full article

Md I. Alam1 Mohammed Albratty1 Hassan A. Alhazmi1,2,3 Asim Najmi1 Khalid Zoghebi1 Muhammad H. Sultan4 Waquar Ahsan1 Shamama Javed4 Md I. Alam4 Abdulelah M. Tawhari5 Abdulrhman A. B. Nasib5 Ali M. M. Fagiri5 Abdulrahman N. S. Alattas5 Waseem H. A. Mosayyikh5
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.
3Medical Research Center, Jazan University, Jazan, Saudi Arabia
4Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
5College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
Virtual Workshop Report: Approaches, Regulatory Challenges, and Advances in Bioequivalence, Dissolution Testing, and Biowaivers: Manila, Philippines, February 22-24, 2023

The virtual workshop, “Approaches, Regulatory Challenges, and Advances in Bioequivalence, Dissolution Testing, and Biowaiver,” was held February 22-24, 2023, via the Zoom online platform. The conference was co-organized by the University of the Philippines College of... Full article

James E. Polli1 Zhao Liu2 Vivian A. Gray3 Willison John E. De Luna4 Andreas Abend2 Michael Daniel C. Lucagbo5 Jie Shen6 Sandra Suarez-Sharp7 Alicia P. Catabay8 Leonel Santos9 Bienvenido S. Balotro10
1University of Maryland, MD, USA.
2Merck Sharp and Dohme, Rahway, NJ, USA.
3Dissolution Technologies, Hockessin, DE, USA.
4Philippine Food and Drug Administration, Alabang, Muntinlupa City, Manila, Philippines.
5School of Statistics, University of the Philippines, Diliman, Quezon City, Philippines.
6Northeastern University, Boston, MA, USA.
7Simulations Plus, Lancaster, CA, USA.
8De La Salle Medical and Health Sciences Institute, Cavite, Philippines.
9Eastern Analytical Symposium, Plainsboro, NJ, USA.
10College of Pharmacy, University of the Philippines, Ermita, Manila, Philippines.
Highlights from 2022 AAPS 360-In Vitro Release and Dissolution Testing Community Annual Meeting

The AAPS In-vitro Release and Dissolution Testing (IVRDT) Community met for their annual inperson meeting at 2022 PharmSci 360 conference in Boston. The meeting was attended by more than 50 active members of the community who participated in an engaged and lively meeting. At the beginning... Full article

Andre Hermans1 Jie Shen2
1Merck & Co., Inc., Rahway, NJ, USA.
2Northeastern University, Boston, MA, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Copley Launches a New Blog for the Pharmaceutical Testing Community

Nottingham, UK: Copley Scientific has launched a blog with the aim of building a trusted, educational resource for anyone involved with pharmaceutical testing. Via regular posts from company experts, the blog will cover... Full article

Logan Instruments Announces Dry Heat Pro Series Dissolution Tester

The Dry Heat Pro Series Dissolution Tester replaces the traditional water bath. Each vessel has three-zone, contemporary, dry heat elements. The unique design ensures there is... Full article

AAPS Announces 2023 Awards Recipients

Awards Program Recognizes Research and Leadership in Pharmaceutical Science Full article

Simulations Plus Releases ADMET Predictor® 11

New functionality, models, and partner data power predictive accuracy from the industryleading machine learning platform Full article

Simulations Plus Receives New FDA Grant Award

Collaboration with regulatory, industry, and academic partners will support and accelerate the development and validation of workflows to conduct virtual bioequivalence studies Full article

Simulations Plus Chief Science Officer Dr. Viera Lukacova Honored as Fellow by the American Association of Pharmaceutical Scientists (AAPS)

Dr. Lukacova’s outstanding contributions to pharmaceutical research and innovation to be recognized with seven others at AAPS PharmSci 360 Full article


Full issue

August 2023 volume 30 issue 3

Evaluation of NanoDis as an Automated Sampling Technology for In Vitro Release Testing of Nanomedicines

Nanoparticles can be used in pharmaceuticals to provide a targeted and prolonged release of active pharmaceutical ingredient (API). Nanoparticles are growing in application in the field of oncology due to developments in the field, but still there are issues faced with studying the in vitro release of long-acting injectables... Full article

Georgia Taylor-Vine1 Heather Mead1 Vasiliki Paraskevopoulou1 James Mann2
1New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
2Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
Factors Influencing the Selection of Medium for Evaluating Drug Solubility and Dissolution in Bovine Milk

Milk or milk-containing beverages can be used as vehicles for drug product administration and as a component of human fed-state simulated gastric fluids. Unprocessed bovine milk is also the matrix within which drugs must be solubilized or released when formulations are administered into the bovine... Full article

Marilyn N. Martinez1 David Longstaff1 Vivek Fellner2 Martin Coffey3
1US Food and Drug Administration Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD, USA.
2Animal Science, Nutrition and Biotechnology, North Carolina State University, Raleigh, NC, USA.
3Research and Development, Bausch and Lomb, Rochester, NY, USA.
Biorelevant Dissolution of Dipyridamole and Piroxicam Using an Automated UV/Vis Spectrophotometric and Potentiometric Dissolution Testing Platform

The objective of this study was to investigate the implications of changing dissolution parameters, including pH ramp time, absence and presence of simulated intestinal fluid (SIF), and the addition of a partitioning phase, using an automated dissolution-testing platform. The molar absorption coefficients, pKa, and dissolution... Full article

Ragna Berthelsen1 Susan Weng Larsen1 Anette Müllertz1,2 Karl Box 33 Jesper Østergaard1
1Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.
2Bioneer:FARMA, Copenhagen, Denmark.
3pION Inc, Forest Row, East Sussex, UK.
Dissolution Profile of Calcium Supplements in Brazil: A Critical Analysis and Formulation Proposal

Low calcium intake is common worldwide and may lead to osteoporosis. Therefore, calcium supplementation is a vital resource to prevent fractures in patients with osteoporosis. The present study aims to assess whether the dissolution profiles of calcium tablets available in the Brazilian pharmaceutical market are... Full article

Rosana Pereira da Silva1 Michele George Issa1 Vinícius Danilo Nonato Bezzon2 Alexandre Gomes Rodrigues3 Humberto Gomes Ferraz1
1Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil.
2Centre for Natural and Human Sciences, Federal University of ABC, Sao Paulo, Brazil.
3Alphaomega Labor, Leipzig, Germany.
Dissolution Method Development for Regulatory Approval: A Comprehensive Review and Case Study

In vitro dissolution testing is an important tool for any oral drug product. It is useful for product development and to ensure the in vivo performance of drug products throughout their commercial life without conducting clinical or bioequivalence studies after regulatory approval. It also plays a role in... Full article

Pramod Parshuramkar1 Deepak Khobragade2 Pranita Kashyap3
1Centaur Pharmaceuticals Pvt. Ltd., Hinjewadi, Pune, India.
2Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.
3Dr. R. G. Bhoyar Institute of Pharmaceutical Education and Research, Wardha, Maharashtra, India.
Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan

The purpose of this study was to perform a comparative dissolution study of various brands of valsartan tablets marketed in Pakistan. This drug belongs to BCS class II, which has high permeability and low solubility. Four different brands of valsartan tablets (80 mg) were collected from the local market of... Full article

Muhammad Mohsin Ansari1 Muhammad Zain Amin1 Usman Ashraf1 Muhammad Noman Ehsan1 Muhammad Farhan1 Aasil1 Hina Ahsan1
1Riphah Institute of Pharmaceutical Sciences, Riphah International University, Islamabad, Pakistan
Release Profile of Branded Atorvastatin Calcium Tablet Relative to Commercially Available Counterpart Generics

Atorvastatin, a hypolipidemic medication, is commonly used as oral anti-atherosclerotic and cardiovascular protectant, with multiple marketed tablet brands available. This study aimed to assess critical quality attributes, including in-vitro dissolution characteristics, for five atorvastatin calcium tablet brands... Full article

Omar Z. Ameer1
1Department of Pharmaceutical Sciences, College of Pharmacy, Alfaisal University, Riyadh, Saudi Arabia
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Copley’s Appointment of New Applications Specialist, Clair Brooks, Highlights Commitment to Exemplary Customer Support.

Prioritising a stronger customer interface and enhanced application expertise as company grows at pace. Full article

Copley Signposts Growing Focus on Pharmaceutical Testing with Appointment of Dedicated Business Development Manager

Delivering enhanced, customer-centric service across the company’s complete portfolio. Full article

Logan Instruments’ Release of Innovative Products

April 2023, Logan Instruments proudly launched the Transdermal Diffusion Flow-Through Cell System, which is available in 6, 8, 12, 16, and 24-cells configurations, offering scalability and flexibility to accommodate diverse research needs. Full article

AAPS PharmSci 360 Opening and Closing Plenary Speakers Announced

Registration for Oct. 22-25 Conference Now Open Full article

Simulations Plus Acquires Immunetrics to Expand its Immunology and Oncology Drug Development Capabilities

Acquisition increases breadth and depth of QSP expertise and range of therapeutic applications Full article

Simulations Plus Launches New Integrated Pulmonary Software and Services Package to Streamline Drug Development and Improve Patient Outcomes

Lancaster, CA -- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced the release of a new integrated pulmonary software and services package. This targeted package will... Full article

Verder Group Acquires ERWEKA

The Verder Group is proud to announce the successful acquisition of ERWEKA, a highly regarded German company renowned for its development and manufacturing of premium tablet testing equipment. Full article

Attend Eastern Analytical Symposium & Exposition: November 13-15, 2023

The Eastern Analytical Symposium and Exposition (EAS) is held annually to showcase leading-edge research and development in analytical chemistry and its allied sciences through the presentation of lectures, workshops, and short courses. An Exposition featuring the latest innovations in laboratory instrumentation and supplies related to these sciences is held concurrently with the symposium. Full article

Distek Receives U.S. Patent for Innovative Dissolution Sample Probe Design

North Brunswick, NJ - Distek, Inc., a reputable leader in laboratory pharmaceutical instruments, is pleased to announce the award of U.S. Patent 11,454,570 for their G2 sampling probe designed for dissolution testing and related applications. Full article


Full issue

May 2023 volume 30 issue 2

Improved Melatonin Dissolution Properties: A Way Forward for Treating Children with Sleep Disorders

Sleep problems, in particular the difficulty in initiating and maintaining sleep are important comorbidities in children and adolescents with attention deficit hyperactivity disorder (ADHD), accompanied by a range of negative consequences for both patients and their caregivers. Melatonin, a naturally occurring hormone that is important... Full article

Jeovanis Gil1 Johan Malm1 György Marko-Varga2
1Section for Clinical Chemistry, Department of Translational Medicine, Lund University, Skåne University Hospital Malmö, Malmö, Sweden.
2Clinical Protein Science & Imaging, Biomedical Centre, Department of Biomedical Engineering, Lund University, Lund, Sweden.
Dissolution Specifications for Ibuprofen Soft Gelatin Capsules: A Proposal

The aim of the present study was to propose a Q dissolution value as a quality control test for 400-mg ibuprofen soft gel capsules using the dissolution recommendations included in the FDA dissolution database. Two commercial batches of the reference product and two batches of three generic products... Full article

Lourdes Mayet-Cruz1 Juan Manuel Rodriguez1 Emily Juárez-López1 Helgi Jung-Cook1
1Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México, México.
Using a Laser Monitoring Technique for Dissolution and Thermodynamic Study of Celecoxib in 2-Propanol and Propylene Glycol Mixtures

In the current work, a laser monitoring technique was used to study dissolution and solubility of celecoxib (CBX) in 2-propanol and propylene glycol mixtures at temperatures of 293.2-313.2 K. The solubility data were fitted to mathematical models, i.e., the van’t Hoff model, the mixture surface model, the Jouyban-Acree... Full article

Vahid Jouyban-Gharamaleki1,2 Fleming Martinez3 Martin Kuentz4 Elaheh Rahimpour1,5 Abolghasem Jouyban1,6
1Pharmaceutical Analysis Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
2Kimia Idea Pardaz Azarbayjan (KIPA) Science Based Company, Tabriz University of Medical Sciences, Tabriz, Iran.
3Grupo de Investigaciones Farmacéutico-Fisicoquímicas, Departamento de Farmacia, Facultad de Ciencias, Universidad Nacional de Colombia - Sede Bogotá, Bogotá, D.C., Colombia.
4Institute of Pharma Technology, University of Applied Sciences and Arts Northwestern Switzerland, Muttenz, Switzerland.
5Infectious and Tropical Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
6Faculty of Pharmacy, Near East University, Mersin, Türkiye.
Biorelevant Dissolution Testing of Numerically Optimized Multiparticulate Drug Delivery Systems of Gliclazide

Gliclazide (GLZ) is an ampholyte with pH-dependent solubility in the gastrointestinal pH range. Although the effects of different pH values on GLZ release have been thoroughly investigated in compendial dissolution media, the effects of gastrointestinal fluid components and pH are not well known. Multiple response... Full article

Ebtesam W. Elsayed1 Ahmed A. El-Ashmawy1 Nadia M. Mursi2 Laila H. Emara1
1Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug Industries Research Institute, National Research Centre, Dokki, Giza, Egypt.
2Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Influence of Storage Conditions on the Pantoprazole Dissolution Profile for Gastro-Resistant Tablet Formulations

Generic formulations share the same active pharmaceutical ingredient (API), but differences in excipients can impact the quality and efficacy of formulations. In this study, four gastro-resistant pantoprazole tablet formulations were selected from the Serbian drug market to compare... Full article

Jelena Čanji Panić1 Nemanja Todorović1 Kristina Jonaš1 Ana Stjepanović1 Gordana ?vonja-Parezanović1 Milana Vuković1 Mladena Lalić-Popović1,2
1Department of Pharmacy, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
2Centre for Medical and Pharmaceutical Investigations and Quality Control (CEMPhIC), Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
Comparative Study of Brand and Generics Ciprofloxacin Tablets Available in the Saudi Market

Introduction: Ciprofloxacin is a fluoroquinolone class of antibiotics with broad-spectrum antibacterial activity. Biowaiver studies of generic ciprofloxacin products can be used to establish bioequivalence with the reference product. Methods: The experiments are carried out using the... Full article

Hassan M. Alsulais1 Ali K. Alqaisum1 Ahmed A. Aldoulah1 Ashfaq A. Mohsin1 Hassan M. Ghonaim1
1Department of Pharmaceutics, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Report on the Virtual Workshop: A Quest for Biowaiver, Including Next Generation Dissolution Characterization and Modeling

The virtual workshop, “A Quest for Biowaiver, Including Next Generation Dissolution Characterization and Modelling,” was held on November 16-17th, 2022, via the MS Teams platform. The conference was co-sponsored by Jagiellonian University Medical College (JUMC) in Cracow, Poland and the American Association of... Full article

Justyna Srebro1 Andreas Abend2 Przemysław Dorożyński3 Nikoletta Fotaki4 Grzegorz Garbacz5 Vivian A. Gray6 James Mann7 Margareth R. Marques8 Aleksander Mendyk1 Xavier Pepin9 Sebastian Polak10,11 Sandra Suarez-Sharp9
1Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Cracow, Poland.
2Pharmaceutical Sciences and Clinical Supplies, MSD, Rahway, NJ, USA.
3Warsaw Medical University, Warsaw, Poland.
4Centre of Therapeutic Innovation (CTI), Department of Life Sciences, University of Bath, Bath, UK.
5Physiolution GmbH, Greifswald, Germany.
6Dissolution Technologies, Hockessin, DE, USA.
7Oral Product Development, Pharmaceutical Technology & Development, AstraZeneca, Macclesfield, UK.
8United States Pharmacopeia, Rockville, MD, USA.
9Simulations Plus, Lancaster, CA, USA.
10Certara, Sheffield, UK.
11Department of Social Pharmacy Jagiellonian University Medical College, Cracow, Poland.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Application of PERMETRO in Bioequivalence and IVIVC

The Logan PERMETRO™ system consists of a proprietary dynamic dissolution-permeation apparatus and novel artificial intestinal membrane. PERMETRO was developed to overcome the limitations and bottlenecks of traditional IVIVC permeation testing by improving prediction of particle engineering, reformulation effects, and bioavailability enhancement. Full article

Simulations Plus and Global Agrochemicals Leader to Collaborate on Machine Learning Models

Data sharing partnership will expand chemical coverage space and improve model performance in support of new approach methodologies to ensure product safety Full article

Simulations Plus Enters New Strategic Collaboration to Discover Anticancer Therapies Through Its AI-Driven Drug Design Technology

Drug discovery services partnership with Sino-American Cancer Foundation focuses on the development of actionable hits against the MTHFD2 target Full article


Full issue

February 2023 volume 30 issue 1

In Vitro Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert Panel

As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug product manufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability in CM. As such, the CM Working Group of the New Advancements in Product Performance Testing (NAPPT)... Full article

Hanlin Li1 lshai Nir2 Andre Hermans3 Raafat Fahmy4 Xujin Lu5 Carrie A. Coutant6
1Vertex Pharmaceuticals, Boston, MA, USA.
2Distek, Inc., North Brunswick, NJ, USA.
3Merck & Co., Inc., Rahway, NJ, USA.
4Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD, USA.
5Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
6Eli Lilly and Company, Indianapolis, IN, USA.
Effect of Mannitol Particle Size on Melatonin Dissolution and Tablet Properties using a Quality by Design Framework

The objective of the current study was to develop an optimized formulation for orally disintegrating tablets (ODTs) containing melatonin. Different particle sizes of mannitol (i.e., filler) were used to study the effects on dissolution and tablet properties using a quality by design (QbD) approach. The quality target... Full article

Burcu Mesut1 Yağmur Pirinçci Tok1 BÜşra Alkan2 Mehtap Kara Vefai3 Mazen Al-Mohaya1 Yildiz Özsoy1
1Pharmaceutical Technology Department, Faculty of Pharmacy, Istanbul University, Istanbul, Turkey.
2Faculty of Pharmacy, Istanbul University, Istanbul, Turkey.
3Pharmaceutical Toxicology Department, Faculty of Pharmacy, Istanbul University, Istanbul, Turkey.
Investigating the Influence of HPMC K4M and Eudragit L 100-55 on Guanfacine-Loaded Extended-Release Tablets

This study aims to optimize the concentrations of hydroxypropyl methyl cellulose (HPMC) K4M and Eudragit L100-55 (methacrylic acid) in formulation of extended-release tablets containing guanfacine hydrochloride by employing a 32-factorial design approach. Extended-release tablets of guanfacine hydrochloride reduce the need for... Full article

Rakesh P. Patel1 Himanshu Paliwal1 Aesha Patel11
1Department of Pharmaceutics and Pharmaceutical Technology, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, India.
Evaluation of Critical Quality Attributes of Dapsone Gel

The purpose of this study was to evaluate critical quality attributes (CQAs) of dapsone gel compared to its marketed reference gel, in accordance with United States Pharmacopeia and draft guidance established by United States Food and Drug Administration, which are based on suggestions about quality and performance of the... Full article

Elmira Kalami1 Emine Kahraman1 Ebru Dedeoğlu2 Koray Gürbüz2 Yildiz Özsoy1 Sevgi Güngör1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Istanbul University, Istanbul, Türkiye
2Assos Pharmaceuticals, Istanbul, Türkiye
Predicting Dissolution of Entecavir Using the Noyes Whitney Equation

The dissolution rate of a drug directly affects its absorption and utilization in vivo. The dissolution test is used to evaluate the quality of formulation and production process. Entecavir is approved by the United States FDA for the treatment of chronic hepatitis B. Entecavir monohydrate (ETV-H) is used in commercial ETV tablets... Full article

Yanlei Kang1 Jiahui Chen1 Zhenyu Duan1 Zhong Li1
1Zhejiang Province Key Laboratory of Smart Management & Application of Modern Agricultural Resources, School of Information Engineering, Huzhou University, Huzhou, Zhejiang, China.
Physicochemical Quality and In Vitro Bioequivalence of Amoxicillin Capsules Marketed in Burkina Faso, Africa

Amoxicillin is a penicillin antibiotic widely prescribed to treat many infections. Several brands of oral forms of amoxicillin are available on the local market. The aim of this study was to evaluate the physicochemical quality and in vitro bioequivalence of several brands of amoxicillin capsules (500 mg) marketed in... Full article

B. Gérard Josias Yaméogo1,2, Wendpouiré Zoungrana-Somé1,2, B. Charles Sombié1, Hermine Zimé-Diawara1, Bertrand Goumbri2, Aïssata Sanfo-Diasso2, Elie Kabré2, and Rasmané Semdé1
1Laboratoire du Développement du Médicament, Centre de Formation, de Recherche et d’Expertises en Sciences du Médicament (CEA-CFOREM), Ecole Doctorale Sciences et Santé, Université Joseph Ki-Zerbo, Ouagadougou, Burkina Faso, Africa.
2Laboratoire National de Santé Publique, Ministère de la Santé, Ouagadougou, Burkina Faso, Africa.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Quality Lab Accessories Launches QLA Korea

Quality Lab Accessories (QLA) is proud to announce our QLA brand expansion into the Asian market with the introduction of QLA Korea. QLA Korea is headquartered in South Korea and operated by Gyujong Lee. Full article

Senior Appointments at Copley Signal Start of New Phase of Growth

03 January 2023; Nottingham, UK: Copley begins 2023 with news of two key appointments to the senior team: Jamie Clayton as Managing Director and Matthew Fenn as Head of Business Development. The appointments follow a period of sustained growth for Copley... Full article

Logan Instruments launches the Inhaler Testing System

Logan Instruments Corp. is pleased to introduce the newest automated AIR-1300 Delivery Dosage Uniformity (DDU) Inhaler testing system and semi-automated next generation impactor (NGI) and Andersen cascade impactor (ACI) systems. Full article

Simulations Plus and University of Florida Awarded New FDA Contract

New Contract to Support Development and Regulatory Assessment of Inhaled Products Full article

Simulations Plus and University of Bath Awarded New FDA Grant

LANCASTER, CA, November 15, 2022 — Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, through a joint proposal with... Full article


Full issue

November 2022 volume 29 issue 4

Dissolution Method Troubleshooting: An Industry Perspective

Quality control dissolution testing represents a key product performance test for solid oral dosage forms and is the most likely QC test to result in laboratory investigations... Full article

James Mann1 Andre Hermans2 Nathan Contrella2 Beverly Nickerson3 Carrie A. Coutant4 Christian Jede5 Shangming Kao6 Dawen Kou7 Emmanuel Scheubel8 Fredrik Winge9 Johanna Milsmann10 Martin Mueller-Zsigmondy11 Nikolay Zaborenko4
1Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
2Analytical Research and Development, Merck & Co., Inc., Rahway, NJ, USA.
3Global CMC, Pfizer Inc., Groton, CT, USA.
4Synthetic Molecule Design & Development, Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.
5Analytical Development, Chemical and Pharmaceutical Development, Merck KGaA, Darmstadt, Germany.
6Analytical Research and Development, Pfizer Inc., Groton, CT, USA.
7Small Molecule Pharmaceutical Sciences, Genentech Inc., South San Francisco, CA, USA.
8Analytical Research and Development, Small Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
9Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.
10Analytical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
11ARD Dissolution & Biopharmaceutics, Novartis Pharma AG, Basel, Switzerland.
In-Vitro Product Performance of Parenteral Drug Products: View of the USP Expert Panel

Performance testing of parenteral products represents a broad arena of product types, test equipment, and analytical challenges. This Stimuli article is one in a series of Stimuli articles on product performance testing focused on common methodological approaches used and challenges encountered in the field of... Full article

Deirdre M. D’Arcy1 Matthias G. Wacker2 Sandra Klein3 Vivek Shah4 Matthew D. Burke5 Gregory Hunter6 Hao Xu7
1School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Ireland.
2Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.
3University of Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany.
4SOTAX Corporation, Westborough, Massachusetts, USA.
5Merck, West Point, Pennsylvania, USA.
6US Food and Drug Administration, Silver Spring, Maryland, USA.
7Zoetis, Kalamazoo, Michigan, USA.
Review: Application of Bioequivalence Testing of Medicines in Peru

This is a review of the current status of drug bioequivalence studies in Peru. A bibliographic search was conducted in PubMed (Medline database) for bioequivalence studies in Peru. Generic drugs constitute the basis of pharmacological requests in health care systems... Full article

Angel T. Alvarado1 Vivian Gray2 Ana María Muñoz3 María Saravia1 María R. Bendezú4 Haydee Chávez4 Jorge A. García4 Roberto Ybañez-Julca5 Andres Chonn-Chang6 Patricia Basurto7 Mario Pineda-Pérez8 Alberto Salazar9
1International Research Network in Pharmacology and Precision Medicine, Human Medicine School, San Ignacio de Loyola University, Lima, Peru.
2V. A. Gray Consulting, Inc., Hockessin, DE, USA.
3Institute of Food Science and Nutrition, ICAN, San Ignacio de Loyola University, Lima, Peru.
4Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
5Faculty of Pharmacy and Biochemistry, National University of Trujillo, Trujillo, Peru.
6Molecular Pharmacology Society of Peru (SOFAR-PERU), Lima, Peru.
7Human Medicine School, Norbert Wiener Private University, Lima, Peru.
8Pharmacy and Biochemistry, Scientific University of the South, UCSUR, Lima, Peru.
9Human Medicine School, San Martín de Porres University, Lima, Peru.
Influence of Storage Conditions on Pharmaceutical Equivalence and Similarity of Hydrochlorothiazide Tablets in Argentina

Similarity studies are used with the intention to establish interchangeability of certain formulations in vitro, without the need to carry out in vivo studies. This interchangeability between formulations should be conserved during the product shelf life, as an integral part of the pharmaceutical stability... Full article

Marta I.V. Brevedan1, María A. Varillas1, and Noelia L. Gonzalez Vidal1,2
1Control de Calidad de Medicamentos, Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, San Juan 670, 8000 Bahía Blanca, Argentina.
2CONICET-UNS, Bahía Blanca, Argentina.
Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia

The objective of this study was to evaluate the physicochemical quality control parameters and pharmaceutical equivalence of amlodipine besylate generic tablets and capsules with the innovator brands (Norvasc and Amlor, respectively) available in Riyadh, Saudi Arabia. Five brands of amlodipine besylate tablets... Full article

Doaa R. Adam,1 Nuran Al Rayes,1 Raghad Fatoum,1 Ghosoun Arafeh,1 Tasneem Rashed Adam,2 and Adeola Kola-Mustapha1,3 Marta I.V. Brevedan1, María A. Varillas1, and Noelia L. Gonzalez Vidal1,2
1Al Faisal University, College of Pharmacy, Riyadh, Saudi Arabia.
2King Saud University, College of Medicine, Riyadh, Saudi Arabia.
3Department of Pharmaceutics and Industrial Pharmacy, University of Ilorin, Ilorin Nigeria.
Book Review: “Analytical Testing for the Pharmaceutical GMP Laboratory”

Analytical Testing for the Pharmaceutical GMP Laboratory (Hunyh-Ba, K.; Holberg, W.; Lin, J.; Ng, L. L.; Gray, V. A.; Famili, P.; Cleary, S.; Wiley, 2022. ISBN 9781119120919) is an excellent and comprehensive book. It includes extensive, concrete instructions and examples of key documents. Full article

Gregory P. Martin1
1Complectors Consulting LLC, Pottstown, PA, USA
Dissolution Best Practices and International Harmonization - AAPS Workshop Report

The AAPS In-Vitro Release and Dissolution Testing (IVRDT) Community and Stability Community jointly organized the virtual workshop “Dissolution Best Practice and International Harmonization,” held on August 16th, 2022. The workshop was designed to bring awareness to differences in dissolution testing and acceptance criteria between... Full article

Vivian Gray1 Andreas Abend2 Mark Alasandro3 Piero Armenante4 Tessa Carducci2 Bryan Crist5 Fasheng Li6 Xujin Lu7 Margareth Marques8 Kevin Moore8 Beverly Nickerson6
1Dissolution Technologies, Hockessin, DE, USA.
2Merck & Co., Inc, Rahway, NJ, USA.
3MZA Pharmaceutical Consulting, San Diego, CA, USA.
4New Jersey Institute of Technology, Newark, NJ, USA.
5DissoAssist, Wilmington, NC, USA.
6Pfizer, Groton, CT, USA.
7Bristol-Myers Squibb, New Brunswick, NJ, USA.
8USP, Rockville, MD, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Simulations Plus Releases GastroPlus® Version 9.8.3

LANCASTER, CA, October 11, 2022 — Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of version 9.8.3 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling platform, GastroPlus®. Full article

New Products from Erweka

Langen, October 11, 2022 — ERWEKA GmbH is proud to announce the release of the digital stand-alone Dissolution Offline System for DT 950/9510 Series and the next generation friability and abrasion tester TAR II. Full article

Logan’s 3-in-1 Automated Dissolution Permeation (ADSP) System

Logan Instruments is proud to announce its newest innovation is a 3-in-1 system: Automated Dissolution Solubility Permeation (ADSP) system, designed to improve efficiency and accelerate development for pharmaceutical R&D. The ADSP system seamlessly integrates... Full article

Agilent Opens Center of Excellence for Dissolution Products

SANTA CLARA, Calif., October 12, 2022 — Agilent Technologies Inc. (NYSE: A) today announced the opening of the Dissolution Center of Excellence (CoE) facility in Craven Arms, United Kingdom. The newly modernized premises will... Full article

Copley launches EnviroMate™, an efficient, benchtop environmental chamber for inhaler testing

Nottingham, UK, September 14, 2022: EnviroMate™ is a benchtop environmental control chamber from Copley, the world’s leading manufacturer and supplier of inhaler testing equipment, designed specifically to improve... Full article


Full issue

August 2022 volume 29 issue 3

Overview of the Activities of the USP Expert Panel on New Advancements in Product Performance Testing

The purpose of this paper is to provide an overview of the activities of the USP Expert Panel on New Advancements in Product Performance testing. Full article

Raymond D. Skwierczynski1 Vivian Gray2 James De Muth1
1USP Expert Panel New Advancements in Product Performance Tests.
2USP Expert Committee Dosage Forms.
The Combination of Liqui-Mass System and Pelletization to Improve Pharmaceutical Properties of Hydrochlorothiazide

Liqui-Pellet technology has recently been developed and has shown to be promising in achieving a rapid drug release rate with water insoluble drugs. At present, only naproxen and ketoprofen have been applied to an oral solid dosage form for immediate release. The present investigation aims to explore the... Full article

Matthew Lam1 Ali Nokhodchi1
1Pharmaceutics Research Laboratory, School of Life Sciences, University of Sussex, Brighton, UK.
Contribution of Multivariate Analysis to the In Vitro Dissolution Profile for Testing Clopidogrel Drugs Similarity

A novel approach to test the similarity of clopidogrel batches by comparing drug dissolution profiles, based on the combination of principal component analysis with hierarchical cluster analysis (PCA-HCA), is presented. Dissolution curves corresponding to five brands of... Full article

Khabbaz Choukri1 El Orche Aimen2 Cheikh Amine3 Bouchafra Houda4 Moulay El Abbes Faouzi5 Cherrah Yahia3,5 Boussen Ratiba1 Mustapha Bouatia6
1Laboratory of Nanotechnology Materials and Environment, Mohammed V University; Faculty of Sciences, Rabat, Morocco.
2Team of Analytical & Computational Chemistry, Nanotechnology and Environment, Faculty of Sciences and Techniques, University of Sultan Moulay Slimane, Beni Mellal, Morocco.
3Abulcasis University of Health Sciences, Cheikh Zaid Hospital, Rabat, Morocco.
4Laboratory of Drug Science, Biomedical Research and Technology, Faculty of Medicine and Pharmacy, Hassan I University, Casablanca, Morocco.
5Laboratory of Pharmacology and Toxicology, Bio Pharmaceutical and Toxicological Analysis Research Team, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco.
6Laboratory of Analytical Chemistry & Bromatology, Faculty of Medicine and Pharmacy, Mohammed V University in Rabat, Rabat, Morocco.
In Vitro Bioequivalence of Acetylsalicylic Acid and Implications in Public Health

Acetylsalicylic acid is one of the most prescribed medications in the world. It is used for prevention of acute myocardial infarction, colorectal cancer, antipyretic, and as an analgesic. This study aimed to investigate the in vitro bioequivalence of three formulations of acetylsalicylic acid, simulating physiological conditions... Full article

María R. Bendezú1 Jorge A. García1 Haydee Chávez1 Ana María Muñoz2 John Jáuregui3 Miguel Mucha3 Ricardo Losno4 María Saravia4 and Angel T. Alvarado4
1Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
2Institute of Food Science and Nutrition, ICAN, San Ignacio de Loyola University, Lima, Peru.
3Environmental Engineering, San Ignacio de Loyola University, Lima, Peru.
4International Network for Research in Pharmacology and Precision Medicine (REDIFMEP), School of Human Medicine, San Ignacio de Loyola University, Lima, Peru.
Comparative Analysis of Commercially Available Acetaminophen Tablets in Saudi Arabia

Acetaminophen is a widely used oral analgesic and antipyretic medication; however, quality control parameters may differ across various brands. The aim of the present study was to evaluate and compare critical quality attributes, including in-vitro dissolution characteristics, of five acetaminophen tablet brands... Full article

Aiman Y. Alwadi1 Ghosoun M. Arafeh1 Mohammad S. Almehlesi2 Hamzah M. Maswadeh2 Ibrahim M. Salman1 and Omar Z. Ameer1
1Department of Pharmaceutical Sciences, College of Pharmacy, Alfaisal University, Riyadh, Saudi Arabia.
2Department of Pharmaceutics, College of Pharmacy, Qassim University, Buraidah, Saudi Arabia.
Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation - Workshop Summary Report

To date, few examples of dissolution models for real-time release testing (RTRT) have been approved for commercial drug products or published in literature. Thus, a structured approach has not been established by which a novice to the field could design, develop, validate, and implement an RTRT dissolution model. Full article

Nikolay Zaborenko1 Tessa M. Carducci2 Alexander Ryckaert3 Haritha Mandula4 Matthew J. Walworth1 Casey J. Smith1 Sandra Suarez-Sharp5 Melanie Dumarey6 Sara Manteiga7 Sarah Nielsen8 Stan Altan9 Adriene Malsbury10 Beverly Nickerson11 Yanmei Lan12
1Synthetic Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN, USA.
2Analytical Commercialization Technology, Merck & Co., Inc., Rahway, NJ, USA.
3Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ghent, Belgium.
4Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD, USA.
5Regulatory Affairs, Simulations Plus Inc., Lancaster, CA, USA.
6Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.
7Analytical Development, Vertex, Boston, MA, USA.
8Janssen Supply Chain, Johnson & Johnson, New Brunswick, NJ, USA.
9Statistics and Decision Sciences, Manufacturing and Applied Statistics, Janssen Pharmaceutical R&D LLD, Raritan, NJ, USA.
10Drug Product Development, Bristol Myers Squibb, New Brunswick, NJ, USA.
11Global Regulatory Affairs CMC, Pfizer Inc., Groton, CT, USA.
12Analytical Development, Pharmaceutical Sciences, Takeda, Lexington, MA, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

RIGGTEK Dissolution Tester “Dissilio”

Martinsried/Munich, Germany - RIGGTEK is is proud to introduce the new Dissolution Tester “Dissilio”. Full article

Simulations Plus Enters New Collaboration to Advance DDDPlus™ Software

Funded partnership with large pharmaceutical company will enhance mechanistic dissolution models for injectable formulations Full article

Logan PERMETRO System - Revolutionizing the World of Bioequivalence Studies

PERMETRO introduces a new way for drug development, such as IVIVC, BE, and the interferences of food or during drug absorption. The system collects samples incrementally and cumulatively at the same time. For the first time, the Logan Permetro system uses a... Full article


May 2022 volume 29 issue 2

Update on Gastrointestinal Biorelevant Media and Physiologically Relevant Dissolution Conditions

Dissolution testing constitutes one of the most widely used in vitro performance tests during drug development and routine quality control testing. It monitors the rate and extent of in vitro drug release (batch release test), and it is often used to... Full article

Daniela Amaral Silva1,2 Neal M. Davies1 Nadia Bou-Chacra2 Humberto Gomes Ferraz2 Raimar Löbenberg1
1Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB, Canada.
2Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil.
Comparison of In Vitro Phosphate-Binding Studies of Sevelamer Carbonate Using Incubator Shaker and USP Dissolution Apparatus II

In the case of most phosphate-binding agents, in vitro phosphate-binding studies are essential for establishing bioequivalence between generic and reference drug formulations. Traditionally, an incubator shaker is used to conduct phosphate-binding studies, but this method is limited by manual sample collection... Full article

Natasha Stella Tibon1 Ravikiran Allada1 Sudhakar Vakkala1 Prakash Muthudoss2 Sajid Syed Shahnawaz1
1Research and Development Department, Novugen Pharma, Selangor, Malaysia.
2Advanced Analytical Laboratory, Oncogen Pharma, Selangor, Malaysia.
Simulated Lymphatic Fluid for In-Vitro Assessment in Pharmaceutical Development

In addition to removing excess extracellular fluid and mobilizing immune cells throughout the body, lymphatic fluid provides a means for drug transport. Lymphatic drug delivery can impart higher efficacy and bioavailability, especially following oral administration. Currently, there is no standardized composition... Full article

Malaz Yousef1,2 Chulhun Park1 Tyson S. Le1 Nadia Bou Chacra3 Neal M. Davies1 Raimar Löbenberg1
1Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB, Canada.
2Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
3Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil.
A Novel Application of an Effervescent Agent in Naproxen Liqui-Pellets for Enhanced Drug Release

Liqui-Pellet formulations have been introduced as a technology to improve the dissolution rate of poorly water-soluble drugs. This study aimed to incorporate sodium bicarbonate (NaHCO3) into the Liqui-Pellet formulation to explore the potential impact on the drug release rate. Naproxen Liqui-Pellet formulations containing... Full article

Matthew Lam1 Ali Nokhodchi1
1Pharmaceutics Research Laboratory, School of Life Sciences, University of Sussex, Brighton, UK.
Study of Drug Release Kinetics of Rosuvastatin Calcium Immediate-Release Tablets Marketed in Saudi Arabia

Rosuvastatin (RST), a BCS class II drug, is a poorly water-soluble antihyperlipidemic agent. The aim of the present work was to determine and compare the drug release kinetics from the RST calcium innovator (Crestor) and generic products (Ivarin and Resova) marketed in Saudi Arabia by employing various... Full article

Waquar Ahsan1 Md Shamsher Alam1 Shamama Javed2 Hassan A. Alhazmi2,3 Mohammed Albratty1 Asim Najmi1 Muhammad Hadi Sultan2
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
3Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.
Pharmaceutical Equivalence of Losartan Potassium Tablets in Argentina

Losartan potassium (LOK) is an antihypertensive agent from the group of selective angiotensin AT1 receptor antagonists, widely used in the form of tablets for oral administration. The available data for BCS classification are confusing, though class III or IV are most likely. The quality attributes of... Full article

María A. Varillas1 Marta I.V. Brevedan1 Noelia L. Gonzalez Vidal1,2
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Bahía Blanca, Argentina.
Highlights From the 2021 AAPS 360 Annual Meeting

The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting and exposition event, PharmSci 360, at the Pennsylvania Convention Center in Philadelphia, PA, October 17-20, 2021. This year the PharmSci 360 meeting was both in-person and virtual. The PharmSci 360 annual meeting... Full article

Dorys Argelia Diaz1 Vivian A. Gray2 Andre Hermans3
1Global Product Development, Pfizer Inc, Groton, CT, USA.
2V. A. Gray Consulting, Hockessin, DE, USA.
3Merck & Co., Inc., Rahway, NJ, USA.


Industry news

Logan UDT-1500 Universal Dissolution Tester

Logan Instruments Corp. is pleased to introduce the UDT-1500 Automated Dissolution Tester (pictured below), the newest apparatus for dissolution testing required by USP. This 15-vessel dissolution tester is designed for easy operation by running one or two methods on a single unit. Full article

Simulations Plus Hosts the 2022 Model-Informed Drug Development (MIDD+) Scientific Conference

Attendees from 57 countries spend 2 days focused on advancing model-informed drug development Full article

Simulations Plus Partners with Large Pharmaceutical Company to Drive Advancements to the GastroPlus Mechanistic Oral Absorption Model

Collaborative research effort will further enhance the ACAT model to aid scientists in the detailed understanding of local drug disposition in the gastrointestinal tract Full article

Pion Highlights 'Game Changing' Method to Measure Dissolution in Real Time

Pion, Inc. ("Pion"), a leading provider of analytical instrumentation for formulation development and quality control in the life sciences industry, has developed a fiber optic method to accurately perform in vitro dissolution testing to gain rich insights into particle molecule behavior, which is not usually seen until in vivo. By gaining pharmacokinetic insights before the clinical trial stage... Full article

American Pharmaceutical Review, a Division of CompareNetworks, Inc. Acquires Tablets & Capsules Magazine from CSC Publishing

CompareNetworks, Inc. (comparenetworks.com), a leading provider of online B2B marketplaces for the scientific and healthcare industries, announced the asset acquisition of Tablets & Capsules (T&C) magazine, a former CSC Publishing publication. Full article


February 2022 volume 29 issue 1

Testing the In-Vitro Product Performance of Nanomaterial-Based Drug Products: View of the USP Expert Panel

This stimuli article is the first in a series to be written by the USP Expert Panel on New Advancements in Product Performance Testing. Today, a wide variety of nanomaterial-based drug products enter the US market, creating the need for reliable standards and technologies to... Full article

Matthias G Wacker1 Xujin Lu2 Matt Burke3 lshai Nir4 Raafat Fahmy5
1Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.
2Bristol Myers Squibb, New Brunswick, New Jersey, USA.
3Radius Health, Inc., Cambridge, Massachusetts, USA.
4Distek, Inc., North Brunswick, New Jersey, USA.
5US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Maryland, USA.
Dissolution Profile of Apixaban Tablets: Method Development and Validation Using HPLC Analysis

Apixaban is an anticoagulant agent that inhibits factor Xa, commercially available as coated tablets at the dosages of 2.5 and 5.0 mg. There is no official monograph of the formulation in the current international pharmacopoeias. From research and development to finished product quality control... Full article

Natália Olegário dos Santos1 Nathalie Ribeiro Wingert1 Martin Steppe1
1Laboratory of Pharmaceutical Quality Control, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
Comparison of Release Rates Derived from Cutaneous Versus Film-Forming Solution Containing Terbinafine: Approach Towards Qualification and Validation of In Vitro Parameters

Excipients play a very important role in the release pattern of an active pharmaceutical ingredient from topical semisolid dosages forms, and their physical and chemical properties can influence the release. The aim of this paper was to provide a validated, sensitive, and reproducible method to assess the... Full article

Yogesh Upadhyay1 Abhishek Kumar Singh1 Dr. Sanjeev Mishra1 Sanjay Jagannath Gurule1 Arshad H. Khuroo1 Soumya Verma2 Neeta Tiwari2 Simrata Bedi2
1Department of Clinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Ltd., Gurugram, Haryana, India.
2Department of Formulation Research Development-Orals, Sun Pharmaceutical Industries Ltd., Gurugram, Haryana, India.
Formulation and Evaluation of Bisoprolol Hemifumarate Emulgel for Transdermal Drug Delivery

The aim of this study was to formulate and evaluate bisoprolol hemifumarate emulgel using carbopol 934P with the enhancers, thymus oil and olive oil. Thymus oil and olive oil were used as permeation enhancers. The emulsion formulations were added to a base gel. The emulgel was characterized for... Full article

Rahman Gul1,2 Yasmin Khan3 Tajala Aman4
1Faculty of Pharmacy & Health Sciences, University of Balochistan, Pakistan.
2Institute of Public Health, Quetta, Pakistan.
3Sardar Bahadur Khan Women University, Quetta, Pakistan.
4Quetta, Pakistan.
Therapeutic Equivalence Evaluated Through In Vitro Studies of Multi-Source Drugs: A Moxifloxacin Case Study in Lima, Peru

This study aimed to determine the therapeutic equivalence of four multi-source drugs containing moxifloxacin (400 mg tablets) in vitro studies to establish their interchangeability with the reference product. Four multi-source products were acquired in pharmaceutical establishments in metropolitan Lima, each from different manufacturing sites...Full article

Victor Chumpitaz-Cerrate1 Luis Moreno-Exebio1 Eliberto Ruiz-Ramirez1 César Franco-Quino1 María Flores-Rodríguez2 and Lesly Chávez-Rimache1
1Grupo “Investigación en Ciencias Básicas Estomatológicas” (ICBEST), Universidad Nacional Mayor de San Marcos, Lima, Perú.
2Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Clearview Pharma Solutions announces two types of consulting services for drug development

San Bruno, California — Clearview Pharma Solutions LLC (www.clearviewpharmallc.com), a pharma/biotech consulting company for drug development announces that is offering two types of retainer services: “Pay for Work” and “Access” Retainer... Full article

Introducing Logan ADSP: Automated Dissolution Solubility Permeation

Logan Instruments is proud to announce its newest innovation is a 3-in-1 system: Automated Dissolution Solubility Permeation (ADSP). The ADSP system is designed to improve efficiency and accelerate development for pharmaceutical R&D. The ADSP system seamlessly integrates the automated dissolution system, automated solubility testing system, and permeation/absorption system (PERMETRO). It has online UV detection and data analytic capabilities... Full article

Simulations Plus Announces the University+ Program

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical and biotechnology industries, today announced the formation of the University+ Program as part of its 25th anniversary celebration... Full article

Quality Lab Accessories (QLA) Announces the BT1000 Dissolution Validation and Reporting System

The Next Innovation in Validation Technology has arrived! The BT1000 Dissolution Validation and Reporting Bluetooth System is a critical tool for any laboratory looking for an easy way to maintain compliance in the digital age. The full suite of specialized, easy-to-use tools and intuitive software platform delivers the speed and flexibility you need to perform quick, efficient, and accurate dissolution tester calibration routines... Full article

Automated Lab Systems Enhanced IDIS Networking Capabilities

IDIS Networking Solution Maximizes Efficiencies January 13, 2022, UK - Automated Lab Systems announces IDIS Data Management Software advanced networking capabilities. Having seen how crucial digital connection is to the modern world today, Automated Lab Systems has adopted IDIS software with Domain Authentication to propel it into an industry leader position for tablet dissolution automation and networking. The company recognizes that... Full article

New Products from ERWEKA

Langen, January 20th, 2022 — ERWEKA GmbH is proud to start the year 2022 with two amazing new products - ERWEKA’s first digital high-volume dissolution tester DT 9510, with its innovative AirLift system for easy raising and lowering of the dissolution head, and the new ZT 730 disintegration tester with AirBasket - ERWEKAs first cable-free disintegration basket with automatic determination of the disintegration time. Full article


November 2021 volume 28 issue 4

Stimuli to the Revision Process: The Case for Apex Vessels

Apex vessels (previously known as PEAK vessels) are an important element of the dissolution scientist’s toolbox and are frequently used in pharmaceutical drug product development settings. However... Full article

James Mann1 Michael Cohen2 Andreas Abend3 Carrie Coutant4 Lee Ashworth1 Robert Shaw1 Gavin Reynolds1 Ishai Nir5 Vivek Shah6 Steven Shaw7 Ashvin Patel7 Xujin Lu8 Vincent Cicale8 Meagan Mccallum8 Sanjaykumar Patel3 Josey Topolski3 Steve Prüfer9 Irena Tomaszewska10 Alexandros Kourentas11 Martin Mueller-Zsigmondy11 Julian Williams12 Matthew Ainge12 Philippe Berben13 Anne Bouquelle13 Bertil Abrahamsson14 Anders Karlsson14 Ria Varghese10 Fasheng Li15 Amy Orce16 Beverly Nickerson16 Xi Shao17
1Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
2Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc. Groton, CT.
3Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ.
4Lilly Research Laboratory, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN.
5Distek, Inc., North Brunswick, NJ.
6Sotax Corp., Westborough, MA.
7Teledyne Hanson Research, Chatsworth, CA.
8Drug Product Development, Global Product Development & Supply, Bristol-Myers Squibb, New Brunswick, NJ.
9ERWEKA GmbH, Langen, Germany.
10Worldwide Research and Development, Analytical Research and Development, Pfizer Inc., Sandwich, UK.
11ARD Dissolution & Biopharmaceutics, Novartis Pharma AG, Basel, Switzerland.
12Agilent Technologies Inc., Craven Arms, Shropshire, UK.
13Pharmaceutical Development, UCB Pharma SA, Braine l'Alleud, Belgium.
14Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.
15Worldwide Research and Development, Analytical Research and Development, PharmSci & PGS Statistics, Pfizer Inc. Groton, CT.
16Worldwide Research and Development, Analytical Research and Development, Pfizer Inc. Groton, CT.
17Analytical Research & Development, Development Sciences, AbbVie, North Chicago, IL.
Influence of Different Concentrations of Surfactants on Dissolution Profiles of Extemporaneously Compounded Pessaries with Clindamycin Phosphate

Three groups of pessaries with clindamycin phosphate as the active substance, and with different concentrations of polysorbate 80 as a surfactant incorporated in the glycerol-gelatin base, were prepared simultaneously. Potential differences... Full article

Vesna Savić1 Ivana Nešić1 Milica Martinović1 Ana Marković1 and Ivana Gajić2
1Department of Pharmacy, Faculty of Medicine, University of Niš, Niš, Republic of Serbia.
2Faculty of Technology, University of Niš, Leskovac, Republic of Serbia.
Comparative Evaluation of In Vitro Drug Release Methods Employed for Nanoparticle Drug Release Studies

The aim of the present study was to experimentally compare the attributes, drawbacks, and limitations of the most commonly employed in vitro drug release test methods for nanoparticle systems and to explore the possibility of... Full article

Suresh K. Paswan1 and T. R. Saini1
1Industrial Pharmacy Research Lab, Department of Pharmacy, Shri G. S. Institute of Technology and Science, Indore, India.
A BCS-Based Biowaiver Approach Using Biphasic Dissolution Test

Biowaivers based on the Biopharmaceutics Classification System (BCS) class can be used to establish therapeutic equivalence based on dissolution tests, which can be used as a surrogate to determine if... Full article

Daniela Amaral Silva1,2 Katherine J. Curo Melo1,2 Neal M. Davies1 Nadia Bou-Chacra2 Humberto G. Ferraz2 Raimar Löbenberg1
1Faculty of Pharmacy & Pharmaceutical Sciences, University of Alberta, Edmonton, AB, Canada.
2Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil.
Quality Attributes and In Vitro Bioequivalence of Amlodipine (5 mg) Tablets in Ica, Peru

Dissolution studies have evolved from quality control testing to being an indicator of biopharmaceutical performance and an alternative to in vivo bioequivalence and interchangeability studies in clinical practice...Full article

Jorge A. García1, María R. Bendezú1, Mario Pineda-Pérez2, Ana María Muñoz3, María Saravia4, and Angel T. Alvarado4
1Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
2Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.
3Research Unit in Nutrition, Health Functional Foods and Nutraceuticals, San Ignacio de Loyola University, Lima, Peru.
4International Network for Research in Pharmacology and Precision Medicine (REDIFMEP), San Ignacio de Loyola University, Lima, Peru.
Summary Report on Workshop on In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods

Virtual Public Workshop Hosted by Center for Complex Generics (CRCG) and US DFA August 18—20, 2021 Full article

Kailas Thakker1
1TopiKail Consulting, Raleigh, NC
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

In Vitro Dissolution with Permeation and IVIVC: Case Study Using a BCS Class III Drug

For rapidly dissolving dosage forms of BCS Class III drugs (high solubility, low permeability), intestinal permeability is considered to be the major rate-controlling step in oral drug absorption. Absorption kinetics of BCS Class III drugs from the gastrointestinal (GI) tract is controlled by biopharmaceutic and physiologic properties of... Full article

Logan Filter Changer System

Logan Instruments is proud to present the filter changer system. The filter changer consists of 20 trays stacked on top of each other, with six syringe filters per tray. This system has an automated... Full article

ERWEKA releases DT 950 Series Dissolution Systems powered by Disso.NET 4.6

Langen, July 12th, 2021 - ERWEKA GmbH is proud to announce the release of the new ERWEKA DT 950 dissolution systems powered by our latest Disso.NET software version 4.6. The software controlled, semi-automatic dissolution systems are the perfect entry to dissolution automation... Full article


August 2021 volume 28 issue 3

Comparison of Efavirenz Release in Biorelevant Dissolution Media Using Manual Sampling and In Situ UV Fiber Optic System

There has been a growing interest in the use of biorelevant dissolution media in drug formulations research and development. Biorelevant media mimic the physiological conditions of the human gastrointestinal tract, which allows for a more discriminating... Full article

Thalita Martins da Silva1,2,3 Marcelo Henrique da Cunha Chaves2,3 Beatriz Ferreira de Carvalho Patricio2,3 Helvécio Vinícius Antunes Rocha1,2,3
1Postgraduate Program in Management, Research and Development in the Pharmaceutical Industry, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
2Laboratory of Micro and Nanotechnology, Institute of Technology of Drugs, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
3Rio de Janeiro Innovation Netword in Nanosystems for Health - NanoSaúde/ FAPERJ, Rio de Janeiro, Brazil.
In Vitro Solubility and Release Profile Correlation with pKa Value of Efavirenz Polymorphs

Efavirenz (EFV) was approved by the United States Food and Drug Administration in 1998 with no polymorphic forms, but further research defined 23 different forms, including amorphous and solvated forms. This study aims to determine the ability of dissolved EFV polymorphs... Full article

Yoga Windhu Wardhana1 Eli Nur Aisyah1 Iyan Sopyan1,2 Taofik Rusdiana1
1Department of Pharmaceutics and Pharmaceuticals Technology, Faculty of Pharmacy, Universitas Padjadjaran (UNPAD), Indonesia.
2Study Center of Drug Discovery and Drug Development, Faculty of Pharmacy, Universitas Padjadjaran (UNPAD), Indonesia.
Development of In Vivo Predictive pH-Gradient Biphasic Dissolution Test for Weakly Basic Drugs: Optimization by Orthogonal Design

The aim of this study was to develop a method for set up and optimization of a pH-gradient biphasic dissolution model by orthogonal test design in light of the correlation with published in vivo data of ketoconazole (KTZ). A pH-gradient biphasic dissolution test... Full article

Xiaowei Fan1 Shengying Shi1 Junlin He1 Jia Deng2,3 Jingou Ji1
1College of Chemistry and Chemical Engineering, Chongqing University, Chongqing, China.
2Chongqing Key Laboratory of Natural Products, College of Environment and Resources, Chongqing Technology and Business University, Chongqing, China.
3Central Nervous System Drug Key Laboratory of Sichuan Province, Luzhou, Sichuan, China.
Conventional Surfactants and a Model Based on Molecular Descriptors as Alternatives to the Drug Solubility in Fasted State Simulated Intestinal Fluid

Biorelevant media, such as fasted state simulated intestinal fluid (FaSSIF), are often used to forecast in vivo behavior of oral solid formulations in the gastrointestinal tract. This study uses conventional surfactants... Full article

Nahal Rahimi Ardabili1 Ali Shayanfar2,3
1Student Research Committee, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
2Pharmaceutical Analysis Research Center, Tabriz University of Medical Science, Tabriz, Iran.
3Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Preparation and Characterization of ZGDHu-1 Nanoparticles

The purpose of this study was to establish the preparation process of ZGDHu-1 nanoparticles and to study its physicochemical properties. The nanoparticles were prepared using a high-pressure homogenization method. Natural phospholipid and soybean oil were... Full article

Lei Shi1 Yong-Li Liu1 Kun-Kun Wu1 Rui-Yang Si1
1Chemical Pharmaceutical Research Institute, Taizhou Vocational & Technical College, Taizhou, P. R. China.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

LOGAN C&D 360 Patch Coat and Drying System

Logan Instruments is proud to present the C&D 360 patch coat and drying (C&D) system with a built-in dryer. The C&D 360 consists of a motorize dual-peak-blade, which controls the thickness of the coating and an online heater to dry the patches. It is designed for small scale production of transdermal patches in the lab. Full article

Pharma Test Announces Improved PT-DDS4 Media Preparation and Degassing System

Germany, Hainburg, July 2021 - Pharma Test announces an improved PT-DDS4 Media Preparation and Degassing System with an optimized tank and pipe outlet with bigger wheels for better daily handling. Full article

DWS Triple Release Offers Major Enhancements

Agilent’s Dissolution Workstation Software (DWS) version 1.7 is now available to further facilitate compliance in your laboratory. This release provides significant updates to all three versions of the DWS platform - the core software for traditional manual or semi-automated systems as well as the 280-DS Mechanical Qualification System (MQS) and 400- DS small volume USP apparatus 7. Full article

ERWEKA releases DT 950 Series Dissolution Systems powered by Disso.NET 4.6

Langen, July 12th, 2021 - ERWEKA GmbH is proud to announce the release of the new ERWEKA DT 950 dissolution systems powered by our latest Disso.NET software version 4.6. The software controlled, semi-automatic dissolution systems are the perfect entry to dissolution automation - no matter what type of system you want to run, from offline, to online... Full article

Distek, Inc. Releases BIOne Mixing System for Upstream and Downstream Benchtop Applications

July 15, 2021, North Brunswick, NJ - From the company that has brought you over 45 years of excellence in laboratory pharmaceutical instruments, Distek, Inc. is proud to introduce the BIOne Mixing System. Full article


May 2021 volume 28 issue 2

Role of Surfactants on Dissolution Behavior of Tamoxifen

Because drug-surfactant interactions are specific, careful choice of surfactant media is required to develop dissolution tests for Biopharmaceutics Classification System (BCS) Class II drugs. The purpose of this study was to investigate the effects of cationic... Full article

Tuba Incecayir1 Seval Olgac1 Duygu Yilmaz Usta1 Zeynep Safak Teksin1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Ankara, Turkey
A Data Set to Verify Volume and Sample Removal Correction Calculations for Dissolution Testing

Software in the form of a spreadsheet, computer program, or web-based application is typically used to perform the appropriate mathematical corrections to dissolution profile data to correct for the amount of sample solution removed from the dissolution vessels at each time interval... Full article

Alger Salt1
1Sal Mea Pharmaceutical Consulting, Durham, NC, USA
Impact of Solvent Selection and Absorptivity on Dissolution Testing of Acetylsalicylic Acid Enteric-Coated Tablets

The objective of this study was to investigate the effect of physiological conditions on the dissolution rate of acetylsalicylic acid (ASA) from two commercial brands compared against compendial tests. All parameters of the analysis were... Full article

Samah A. Ata1 Ola A. Tarawneh1 Rana H. Sejare2 Suhair Z. Sunoqrot1 Rania A. Al-Qirim1
1Department of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan
2Department of Pharmacy, Middle East University, Amman, Jordan
Assessment of Drug Release Kinetics and Quality of Naproxen Generic Tablets in Bangladesh

The present study aimed to compare the in vitro equivalence of different generic tablets of naproxen available with the reference brand in the Bangladesh pharmaceutical market. As naproxen belongs to the... Full article

Madhabi Lata Shuma1 Amrin Jahan1 Shimul Halder2
1Department of Pharmacy, Stamford University Bangladesh, Siddeswari Dhaka, Bangladesh.
2Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka, Bangladesh.
In Vitro Biopharmaceutical Equivalence of Carbamazepine Sodium Tablets Available in Lima, Peru

Carbamazepine is an antiepileptic iminostilbene that is dispensed from multiple sources in Peru without bioequivalence studies. The biopharmaceutical equivalence of two generic (A and B) and one commercial brand (C) of carbamazepine sodium as compared to the innovator drug was determined by...Full article

Angel T. Alvarado1, Ana María Muñoz2, María R. Bendezú3, Juan J. Palomino-Jhong3, Jorge A. García3, César André Alvarado4, Erick A. Alvarado4, Gaby Ochoa-Pachas5, Mario Pineda-Pérez5, and Mario Bolarte5
1International Network for Research in Pharmacology and Precision Medicine, School of Human Medicine, San Ignacio de Loyola University, Lima, Peru.
2Research Unit in Nutrition, Health, Functional Foods and Nutraceuticals, Universidad San Ignacio de Loyola, Lima Peru.
3Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
4Faculty of Human Medicine, University of San Martín de Porres, Lima, Peru.
5Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.

Evaluation of In Vitro Equivalence of Commonly Available Generic Brands of Amlodipine Tablets in Saudi Arabia Under Biowaiver Conditions

When a medicine is not able to treat the disease for which it was intended, as in case of substandard and falsified drug products, it may prolong the disease and in worst scenario, the patient may die because of the untreated illness or the product itself. To ensure the quality and safety of medicine, WHO recommends...Full article

Asim Najmi1, Mohammed Al Bratty1, Bassam Abdullah Al-Bassam1, Rami Ali Aseri1, Turki Suliman Wadani1, Abdulrahman Ibrahim Al-Muntashiri1, Hassan A. Alhazmi1,2, Muhammad H. Sultan3, and Sadique A. Javed1
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.
3Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.

Highlights from the 2020 AAPS 360 Annual Meeting

The American Association of Pharmaceutical Scientists (AAPS) held its PharmSci 360 Annual Meeting and Exposition event, October 26-November 5, 2020. PharmSci 360, a premier gathering of pharmaceutical scientists from around the world, was fully virtual. Full article

Vivian A. Gray1 Dorys Argelia Diaz2 Jennifer Dressman3 Yasuhiro Tsume4 Nikoletta Fotaki5
1V. A. Gray Consulting, Hockessin, DE, USA.
2Global Product Development, Pfizer Inc, Groton, CT, USA.
3Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt, Germany.
4Biopharm-Sterile & Specialty Product, Merck & Co., Rahway, NJ, USA.
5Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.
Book Review: “In Vitro Drug Release Testing of Special Dosage Forms,” Advances in Pharmaceutical Technology Series, Edited by Fotaki and Klein

The latest addition to the Advances in Pharmaceutical Technology Series entitled In Vitro Drug Release Testing of Special Dosage Forms (Fotaki, N.; Klein, S.; Eds., John Wiley and Sons, 2020. ISBN 9781118341476) is a fascinating book that charts the... Full article

Greg Martin1
1Complectors Consulting LLC, Pottstown, PA, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Copley Announces a Major Upgrade of World’s ‘Go To’ Inhaler Testing Portfolio

01 March 2021, Nottingham, UK: Copley Scientific, the global leader in inhaler testing equipment, is marking the company’s 75th anniversary with a significant upgrade of its comprehensive, integrated range for measuring the critical attributes of orally inhaled and nasal drug products (OINDPs), notably delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). The upgrade marks a major evolution in Copley’s offering, which now includes... Full article

Automated USP 4 UV Online System, System ADR III-7, and Permetro 3700

Logan Instruments is proud to present the 4000 UV Online System. The System 4000 Online consists of six essential devices based on the Disso 4000. It is a USP apparatus 4 automated with a system controller and sample collector. One of the many applications worth mentioning is the system’s capability to test injectables. The dissolution profile below was generated by the System 4000. Full article

DT 950 - ERWEKAs First digital Dissolution Tester

ERWEKA GmbH is proud to announce the release of its first digital Dissolution Tester - the ERWEKA DT 950 series. Equipped with groundbreaking embedded PC technology, a 7" touch display with advanced, easy to use interface, the intelligent TestAssist for simple error-proof testing and an unprecedented upgradeability, the DT 950 series with 6, 7, or 8 test stations, is ready for the requirements of today and for the challenges of the future. Full article

Applications Expanded for Agilent 400-DS

With the development of novel dosage forms, dissolution testing requirements for combination medical devices becomes continually more important. While initially designed for the testing of drug-eluting stents, the Agilent 400-DS has evolved to fulfill requirements. It can test products including medicated contact lenses, pacemaker leads, implants, and polymeric rings. As many of these tests are performed over long time periods, the 400-DS combines the traditional USP apparatus 7 requirementswith innovative design attributes that make it ideal for such experiments. Full article

Distek, Inc. Releases BIOne 1250 Dual Bioprocess Control Station

North Brunswick, NJ - From the company that has brought you over 45 years of excellence in laboratory pharmaceutical instruments, Distek, Inc. is proud to introduce the BIOne 1250 Dual Bioprocess Control Station. Full article


February 2021 volume 28 issue 1

Disintegration and Rupture Testing of Omega-3 Soft Capsules

Omega-3 fatty acid soft capsules are a popular nutritional supplement. Previous product quality studies reported in the literature have mostly only addressed specifications for omega-3 fatty acid content and chemical stability aspects. This study aimed to... Full article

Nasser N. Nyamweya1 Teddy M. Mochama1
1Department of Pharmaceutics and Pharmacy Practice, School of Pharmacy, College of Health Sciences, University of Nairobi, Nairobi, Kenya.
Comparison of Generic Furosemide Products by In Vitro Release Studies using USP Apparatus 2 and 4

Dissolution studies are essential for comparing the quality of generic drugs to their reference products. The objective of this work was to evaluate the in vitro release of furosemide in tablets under official dissolution conditions and using the flow-through cell method. To this end... Full article

José Raúl Medina-López1 Alexander Domínguez-Reyes1 Marcela Hurtado1
1Departamento Sistemas Biológicos, Universidad Autónoma Metropolitana-Xochimilco, Mexico City, Mexico.
Quality Assessment of Brands of Prednisolone (5 Mg) Tablets Marketed in Abuja Metropolis of Nigeria

This study aims to evaluate the quality of brands of prednisolone tablets marketed in Nigeria. Quality control parameters such as weight variation, hardness, friability, disintegration, assay, and dissolution were assessed. Ten of 11 brands tested met the... Full article

Johnson A. Isaac1 Galadima I. Hayatu2 Judith E. John1 Kokonne E. Ekere1 Aisha Daburi3 Sunday O. Omachoko4 Philip F. Buiders1
1Department of Pharmaceutical Technology and Raw Materials Development, National Institute for Pharmaceutical Research and Development, Abuja, Nigeria.
2Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development, Abuja, Nigeria.
3Department of Pharmacology and Toxicology, National Institute for Pharmaceutical Research and Development, Abuja, Nigeria.
4Department of Pharmacy, Nisa Premier Hospital, Jabi, Abuja.
Biowaiver Study of Selected Solid Oral Prednisolone Products Available in Sri Lanka: Recommendations for Comparator Product Used in Biowaiver Testing

This post-marketing study on prednisolone products in Sri Lanka was conducted using BCS-based biowaiver procedures for performing in vitro bioequivalence studies. The market leader product with the highest availability was selected as the comparator in the absence of the... Full article

Hiruni Rathnayake1,2 Dhanusha Thambavita1 Priyadarshani Galappatthy1
1Department of Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Sri Lanka.
2Department of Chemistry, Faculty of Science, University of Colombo, Sri Lanka.
Comparative Assessment of Critical Quality Attributes of Sildenafil Tablets

Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence...Full article

Marta I.V. Brevedan1, María A. Varillas1, and Noelia L. Gonzalez Vidal1,2
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas, Bahía Blanca, Argentina.
In Vitro Biopharmaceutical Equivalence of 5-mg Glibenclamide Tablets in Simulated Intestinal Fluid Without Enzymes

This research evaluated the biopharmaceutical equivalence in vitro of three brands of glibenclamide 5-mg tablets (reference, brand name, and generic drugs) from Lima, Peru following the guidelines of the Biopharmaceutical Classification System (BCS). Glibenclamide is a BCS class 2 drug. Quality control parameters were evaluated including hardness, weight, friability, and drug content...Full article

Angel T. Alvarado1, Ana Maria Muñoz2, Maria Bendezú3, Jorge A. García3, Juan J. Palomino-Jhong3, Gaby Ochoa-Pachas4, Andres Chonn-Chang4, Luis Sullon-Dextre4, Berta Loja-Herrera4, and Mario Pineda-Perez4,5
1International Research Network in Pharmacology and Precision Medicine, Human Medicine School, San Ignacio de Loyola University, Lima, Peru.
2Research Unit in Nutrition, Health, Functional Foods and Nutraceuticals, Universidad San Ignacio de Loyola (UNUSAN-USIL), Lima, Peru.
3Faculty of Pharmacy and Biochemistry, National University San Luis Gonzaga, Ica, Peru.
4Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.
5Departmental Pharmaceutical Chemical College of Lima, Peru.
Performance Tests - Update on USP Activities

The European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP) participate in the process of harmonization of general chapters and excipients monographs (1). Each of these pharmacopeias publishes proposals for... Full article

Margareth R. C. Marques1
1United States Pharmacopeial Convention, Inc., Rockville, MD, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

New e-Training Service from Copley for Pharmaceutical Testing

Copley Scientific is now delivering e-Training, offering customers across the globe remote access to expert tuition on in vitro test methods for pharmaceutical dosage forms, notably for orally inhaled and nasal drug products (OINDPs). Customers can choose from a range of standard training packages or specify a bespoke session, with reliable, professional, live-streaming ensuring a high quality, interactive experience. Sessions on Installation Qualification and Operational Qualification (IQ/OQ) help customers to get new systems up and running while application-specific training ensures best practice. Full article

Distek’s New ezfill+ Dissolution Media Preparation System Now Offers Data Integrity Support

North Brunswick, NJ — Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry has just released its new ezfill+. Like the ezfill 4500 predecessor, the ezfill+ allows rapid, effective deaeration and precise media volume delivery. In addition, the new ezfill+ includes a touch screen and intuitive user interface that allows for stored methods, user logins, reports, and printing or remote storage. If the user prefers, the ezfill+ has a “simple mode” that does not require a login or predefined methods. Full article

Agilent Announces Innovation Award and Product Updates

Agilent Technologies Inc. has announced that the newly launched NanoDis System has been included in the Innovation Awards from The Analytical Scientist (https://theanalyticalscientist.com). The recently launched NanoDis System utilizes cross-flow filtration—used traditionally in industrial process chemistry — combined with conventional dissolution instruments to enable nanoparticle dissolution testing. Along with the introduction of automation for the complete workflow, the novel new system improves the process of getting new drugs to market. Full article

Logan New Economical Transdermal Diffusion Cell Drive Consoles

We are proud to announce a new addition to our transdermal diffusion cell testers family — the Logan “E” series — Economical Transdermal Diffusion Cell Drive Consoles. Logan” E” series offers simplicity in design with very affordable prices. Full article


November 2020 volume 27 issue 4

Filters in Dissolution Testing: Evaluation and Selection

Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. Filtration is one of the simplest sample preparation techniques. Regardless... Full article

Janet Smith1 Jesmi George1 Timothy Nadler1 Vivek Joshi1
1EMD Millipore Corp., Burlington, MA, USA.
Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina

Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API)... Full article

María A. Varillas1 Marta I.V. Brevedan1 Noelia L. Gonzalez Vidal1,2
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur (UNS), San Juan, Bahía Blanca, Argentina.
2CONICET, Argentina.
In Vitro Bioequivalence of Pregabalin Capsules (150 mg): An Alternative to In Vivo Bioequivalence Studies

Introduction: We aimed to study the dissolution behavior of available brands of pregabalin in the United Arab Emirates(UAE) (Ras Al Khaimah) market and to report efficiency and fungibility data for generic brands under biowaiver conditions. Methods: The pharmaceutical parameters of five brands of pregabalin... Full article

Shahnaz Usman1 Ahmed Saeed2 Sakina Fatima3 Sakina Fatima1 Venkat Ramesh1 Fasiha Shah1 Quamrul Islam1
1Department of Pharmaceutics, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences University, Ras Al Khaimah, UAE.
2Quality Assurance, Akhai pharmaceutical (Pvt) Ltd. Karachi, Pakistan.
3Department of Pharmaceutics, Institute of Pharmaceutical Sciences, Jinnah Sindh Medical University, Karachi, Pakistan.
In Vitro Therapeutic Equivalence of Two Multisource (Generic) Formulations of Sodium Phenytoin (100 mg) Available in Peru

This in vitro study evaluated the therapeutic equivalence of two multisource (generic) formulations of 100-mg phenytoin as immediate-release tablets available in the Peruvian pharmaceutical market, compared with the reference medicine,to establish interchangeability... Full article

Angel T. Alvarado1 Ana Maria Muñoz1 Jessica M. Miyasato2 Erick A. Alvarado2 Berta Loja2 Laura Villanueva3 Mario Pineda3 Maria Bendezú4 Juan J. Palomino-Jhong4 Jorge A. García4
1School of Human Medicine, San Ignacio de Loyola University, Lima, Peru.
2Peruvian Association of Immunogenomics and Personalized Medicine, Lima, Peru.
3Faculty of Pharmaceutical Sciences and Biochemistry, Inca Garcilaso de la Vega University, Lima, Peru.
4Faculty of Pharmacy and Biochemistry, San Luis Gonzaga National University of Ica, Ica, Peru.
In Vitro Comparative Dissolution Assessment of Different Brands of Co-Amoxiclav Tablets in Pakistan

Dissolution test results are the principal indicator in estimating the in-vivo bioavailability of most oral solid dosage forms and are an important quality attribute to assess the generic formulation. This study was designed to assess the release of co-amoxiclav from finished pharmaceutical solid dosage formulations...Full article

Muhammad Khurram Waqas1 Rehan Ali1 Muhammad Usman1 Muhammad Nabeel Shahid1 Akhtar Rasul2 Barkat Ali Khan3 and Ghulam Murtaza4
1Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, Pakistan.
2College of Pharmacy, Government College University, Faisalabad, Pakistan.
3Faculty of Pharmacy, Gomal University, Dera Ismail Khan, Pakistan.
4Department of Pharmacy, COMSATS University Islamabad, Lahore Campus, Pakistan.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA
Dissolution Technologies Policy Update: Generic Comparison Studies to be Published Online Only

Generic comparisons occur when an article provides data on two or more manufacturers of the same drug product and compares the dissolution profiles. Sometimes this comparison...

Vivian Gray1
1Managing Director, Dissolution Technologies, Hockessin, DE, USA


Industry news

Pharma Test Introduces Cooling Racks for Dissolution Sampling Robot

October 2020: Hainburg — Pharma Test introduces cooling racks for the Dissolution Sampling Robot DSR-M. The Dissolution Sampling Robot DSR-M can now be equipped with optional cooling racks that allow for cooling the collected samples and to maintain a stable temperature of as low as 5 °C (41 °F) by use of a conventional laboratory refrigerated circulator. Full article

Logan New Economical Transdermal Diffusion Cell Drive Consoles

Logan Instruments strives to deliver only the best design and provide the most careful and satisfying customer experience to our customers. We are proud to announce a unique addition to the transdermal diffusion cell systems family - the LOGAN “E” series - Economical Transdermal Diffusion Cell Drive Consoles. The biggest advantage of the Logan E series is that customers purchase only one unit, rather than a multi-part unit. Full article

Logan Instruments’ PB-M Officially Launching in International Markets

Logan’s Permeation-Barrier Membrane (PB-M) is a cellulose membrane. This model has similar acidity to human epidermis which allows the transfer of novel drugs. Regardless of the polarity of the substance, the diffusion of different drugs may be analyzed through the membrane. Measurements with the barrier are easy, fast, and reproducible. Each PB-M’s diameter is 25 mm when packed in a 5-cavity plate. The membranes need to avoid sun light exposure and UV radiation. They expire after 2 years. Full article

NEW NanoDis System is Key for Nanoparticle Filtration Success

October 10, 2020 - Uncover the best nanoparticle formulation faster, get products to market earlier, and easily transition nanoparticle dissolution testing from R&D to manufacturing with the new NanoDis System from Agilent. Using established and compliant apparatus that can be automated, the new NanoDis System is ideal for both R&D and QA/QC environments and is available to order November 2020. Full article


August 2020 volume 27 issue 3

The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?

The purpose of this article is to inform the dissolution scientist of a powerful emerging tool that provides in vivo linkage to dissolution methods. This tool is physiologically based biopharmaceutics modelling (PBBM). Dissolution scientists are mostly concerned with analytical sections of drug development... Full article

Vivian A. Gray1 James C. Mann2 Richard Barker3 Xavier J. H. Pepin3
1V. A. Gray Consulting, Inc., Hockessin, DE, USA.
2Oral Product Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield, UK.
3New Modalities and Parenteral Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield, UK.
Investigation of Dissolution Performance of Hard Gelatin Capsule Products Using Various Sinkers

Dissolution testing is a commonly used tool for the quality control of various dosage forms. For this purpose, consistent test conditions are necessary to obtain reproducible test results. Typical issues that can affect the dissolution performance of tested capsule formulations are floating and coning. Recently... Full article

Yaser Mansuroglu1 Jennifer Dressman1,2
1Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.
2Fraunhofer Institute of Molecular Biology and Applied Ecology (IME), Division of Translational Medicine and Pharmacology (TMP), Frankfurt am Main, Germany.
Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes

For a dissolution method to be considered relevant to in vivo performance, the dissolution data profiles should show discrimination or meaningful change when there is a change in critical material attributes (CMA) and critical product properties (CPP). The dissolution test has been shown repeatedly to have the power to... Full article

Vivian A. Gray1
1V. A. Gray Consulting, Inc., Hockessin, DE, USA
Meeting Report: Dissolution Testing, Biowaiver, and Bioequivalence

The first joint workshop sponsored by the American Association of Pharmaceutical Scientists (AAPS) and the Peruvian College of Pharmacists “Colegio Quimico Farmaceutico del Peru (CQFPE)” was entitled “Dissolution Testing, Biowaiver, and Bioequivalence” and was held in Lima, Peru on... Full article

Vivian A. Gray1 Dorys Argelia Diaz2 Susan D’Souza3,4
1V. A. Gray Consulting, Inc., Hockessin, DE, USA
2Global Product Development, Pfizer Inc, Groton, CT, USA.
3Prevail Therapeutics, New York, NY, USA.
4Present: Tenaya Therapeutics, South San Francisco, CA, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA
Dissolution Technologies Article Submission Guidelines

These guidelines are effective September 1, 2020. Please forward questions and comments to the Research Editor, Vivian Gray, vagray@rcn.com




Industry news

Mega Flagship Event of SPDS - DRPI ONLINE - 2020 — attended by Pharma Professionals & Academia

Society for Pharmaceutical Dissolution Sciences (SPDS) in collaboration with Association of Pharmaceutical Teachers of India (APTI) organized their mega flagship event for young researchers in the field of Pharmaceutical Sciences, DISSO RESEARCH PRESENTATIONS INDIA (DRPI) 2020 - ONLINE on June 4th, 5th, and 7th. Full article

Sandra Suarez-Sharp Joins Simulations Plus to Lead Regulatory Strategies Team

20-year FDA Master Reviewer will advise the planning of drug development programs with sponsor companies Full article

LOGAN INSTRUMENTS Launched THE PERMETRO SYSTEMS in International Markets

A Dissolution and Permeation All-In-One System Full article

SYSTEM 4000 and Logan Instruments Corp.

After months of research, LOGAN is proud to present the SYSTEM 4000, an automated USP apparatus 4 sampling system. Full article

Industry News: “A Novel Approach for the In-Vitro Drug Release Testing of Metered Dose Inhalers”

In late June 2020, Bryan Crist, Scientific Affairs Manager for Agilent’s Dissolution business, in conjunction with the Controlled Release Society’s annual meeting, presented “A Novel Approach for the In-Vitro Drug Release Testing of Metered Dose Inhalers.” Full article


May 2020 volume 27 issue 2

Amorphous Solid Dispersions in Early Stage of Formulation Development: Predicting Excipient Influence on Dissolution Profiles Using DDDPlus

Excipients play an important role in the formulation of dosage forms and can be used to improve the bioavailability of a drug through physical interactions that alter the rate of dissolution of a drug. The objective of this study was to predict the effect of formulation on the dissolution rate of a poorly soluble drug using computer simulations. Full article

Juliet Obianuju Njoku1 Dwaipayan Mukherjee2 Gregory K. Webster2 Raimar Löbenberg1
1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada.
2Research and Development, AbbVie, Inc., North Chicago, IL, USA.
A Look at Cleaning Effectiveness in Automated Dissolution Systems

Cleaning in any Good Manufacturing Practice (GMP) laboratory is an important aspect of the analytical experiment. The laboratory must ensure the equipment does not contain residual active pharmaceutical ingredients (APIs) or impurities that may affect the outcome of any current or future experiments. Full article

Gregory K. Webster1 Xi Shao1 Kenneth A. Nelson1 Matthew A. Gragg1
1Analytical Research & Development, AbbVie Inc., North Chicago, IL, USA.
Drug Release Pattern of Oral Dual-Release Pellets Through the Gastrointestinal Tract: Case Example of Diclofenac Sodium

The purpose of this research was to evaluate the release pattern of the dual-release pellets of diclofenac sodium (DS), coated with enteric- and sustained-release layers, in dissolution media that resemble the physiological variables of the gastrointestinal (GI) fluid. Dissolution testing in three pH stages (acidic, intermediate, and basic) was conducted using USP apparatus I (basket) rotating at 100 rpm. Full article

Rania Hamed1 Sabreen Hasan Alnadi1
1Department of Pharmacy, Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.
Effect of Medium pH on In Vitro Dissolution of Marketed Tetracyclines (Tetracycline and Doxycycline) Solid Oral Dosage Forms in Bahia, Brazil

Tetracyclines are widely used for the treatment of infections of the lower respiratory tract and other systems. In Brazil, tetracyclines are available as generic and similar products. The aim of this study was to evaluate the in vitro release of tetracycline capsules (500 mg) and doxycycline tablets (100 mg) in different reaction media, from dissolution profiles, using sensitive and rapid ultraviolet spectrophotometric methods. Full article

João Luis S. de Oliveira1 Gilmar A. C. Teles Júnior1 Desirée A. Bonfim1 Carlos Magno R. Carvalho Júnior1 Jéssica A. Santos1 Matheus S. Ferreira1,2 Aníbal de F. Santos Júnior1
1Department of Life Sciences, State University of Bahia, Salvador, Bahia, Brazil.
2Department of Exact and Earth Sciences, State University of Bahia, Salvador, Bahia, Brazil.
American Association of Pharmaceutical Scientists (AAPS) and Chinese National Institutes for Food and Drug Control (NIFDC) Joint Workshop on Dissolution, Bioequivalence, Product Performance, and Quality

The second joint workshop sponsored by the American Association of Pharmaceutical Scientists (AAPS) and the Chinese National Institutes for Food and Drug Control (NIFDC) took place in Yantai, China, from May 31 to June 1, 2019. The theme of the workshop was Dissolution, Bioequivalence, Product Performance, and Quality. Full article

Xujin Lu1 Baoming Ning2 Nikoletta Fotaki3 Sandra Suarez Sharp4,5 Diane Burgess6 Samir Haddouchi7
1Bristol Myers Squibb Company, New Brunswick, NJ, USA.
2National Institutes for Food and Drug Control, Beijing, China.
3University of Bath, Bath, UK.
4Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
5Current: Simulations Plus Inc., Lancaster, CA, USA.
6University of Connecticut, Storrs, CT, USA.
7SPS Pharma Services, Orléans, France.
Workshop Report: USP Workshop on Advancements in In Vitro Performance Testing of Drug Products

In December 2019, The United States Pharmacopeia (USP) organized a 2-day workshop to explore new approaches to assess in vitro performance of drug products. Experts from around the globe presented processes, techniques, systems that can be used to evaluate and model in vitro performance of different pharmaceutical dosage forms. The following is a summary of most of the presentations and the highlights of the discussions that ensued. Full article

Andre Hermans 11 Przemyslaw Dorozynski 22 Fernando J. Muzzio 33 Hanlin Li 44 Sarah Nielsen 55 Shirlynn Chen 66 Christos Reppas 77 Sandra Klein 88 Sanjaykumar Patel 11 Matthias Wacker 99 Kailas Thakker 1010 Katharina Pruessmann 88 Anne Seidlitz 88 Tapash K. Ghosh 1111 Yang Yang 1212 Daniel Willett 1313 Guenther Hochhaus 1414 Justin Tay 99 Celine V. Liew 99 Paul W. S. Heng 99 Changquan Calvin Sun 1515 Johannes Kraemer 1616 Margareth R. C. Marques 1717
1Merck & Co., USA.
2Instytut Farmaceutyczny, Warsaw, Poland.
3Rutgers University, USA.
4Vertex Pharmaceuticals, USA.
5Janssen Pharmaceuticals, USA.
6Boehringer Ingelheim Pharm. Inc., USA.
7National and Kapodistrian University of Athens, Greece.
8University of Greifswald, Germany.
9Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.
10Tergus Pharma, LLC, USA.
11United States Food and Drug Administration (US FDA), USA.
12Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA, USA.
13Division of Pharmaceutical Analysis, Office of Testing and Research, OPQ, CDER, US FDA, USA.
14College of Pharmacy, University of Florida, USA.
15Department of Pharmaceutics, University of Minnesota, USA.
16DISSO GmbH, Germany.
17United States Pharmacopeia, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Distek, Inc. Releases Small Volume Conversion Kit for Model 2500 Select Bathless Dissolution Tester

March 27th, 2020: North Brunswick, NJ - Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry for over 40 years, just announced the release of their small volume conversion kit for the Model 2500 Select bathless dissolution tester, combining the advantages of bathless instruments with small dissolution volumes. Full article

Copley Scientific Introduces a Simple Device for Inhaled Dose Dissolution Testing

10th February 2020, Nottingham, UK: The new Inhaled Dissolution Dose Collector (IDDC) from Copley Scientific is a flexible, easy-to-use system for collecting the respirable fraction of the dose delivered by a metered dose inhaler (MDI) or dry powder inhaler (DPI) for dissolution testing. The dissolution profile of inhaled drugs underpins therapeutic efficacy... Full article

Copley Adds a New Distributor in China

Copley Scientific, a global supplier of pharmaceutical testing equipment, has appointed Welch Materials Inc. as exclusive distributors for its complete portfolio of tablet, powder, suppository, and semisolids testing products. The appointment will bring customers in this vital region enhanced sales and support service delivered by dedicated, knowledgeable local experts. Full article

New ERWEKA Dissolution Online System Integrated with Thermo Scientific Evolution 350 Spectrophotometer

Langen, April 1st, 2020 - ERWEKA GmbH is proud to announce a new Dissolution Online UV-Vis System that seamlessly integrates with the Thermo Scientific Evolution 350 spectrophotometer. Full article


February 2020 volume 27 issue 1

In Vitro Release Testing (IVRT) of Topical Hydrocortisone Acetate Creams: A Novel Approach Using Positive and Negative Controls

The objective was to develop and validate an in vitro release testing (IVRT) method to assess the release of hydrocortisone acetate (HCA) from five topical formulations. A marketed generic cream containing 1% HCA was used as the reference product. Vertical diffusion cells (VDCs) were used to assess... Full article

Nyengeterai Amanda Mudyahoto1 Seeprarani Rath1 Ashmita Ramanah1 Isadore Kanfer1,2
1Division of Pharmaceutics, Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa.
2Leslie Dan Faculty, University of Toronto, Toronto, ON, Canada.
In Vitro Comparative Quality Evaluation of Non-Expired and 10 Years-Expired Lamotrigine Immediate-Release Tablet Formulations - Pilot Study

This study aimed to compare the different physical parameters and dissolution profiles of 10 years-expired with nonexpired lamotrigine (LTG) immediate-release tablet formulations. Dissolution tests were conducted using a validated high-performance liquid chromatography method. Full article

Gordana ?vonja Parezanović1 Mladena Lalić-Popović1 Svetlana Goločorbin-Kon1 Nemanja Todorović1 Neboj?a Pavlović1 Momir Mikov2
1Faculty of Medicine, Department of Pharmacy, University of Novi Sad, Serbia.
2Faculty of Medicine, Department of Pharmacology, Toxicology and Clinical Pharmacology, University Novi Sad, Serbia.
Comparison of Dissolution Profiles and Apparent Permeabilities of Commercially Available Metformin Hydrochloride Tablets in Turkey

The purpose of this study was to evaluate the similarity of dissolution and permeability properties of commercially available immediate-release metformin hydrochloride (MH) tablets (1000 mg strength) including five generic products obtained from the Turkish drug market (tablets A-E) and two reference products... Full article

Yagmur Akdag1 Tugba Gulsun1 Nihan Izat1 Levent Oner1 Selma Sahin1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey.
Dissolution Method Evaluation for Carvedilol Tablets

Carvedilol is an antihypertensive agent with blocking non-selective (selectivity for β1 and β2 adrenoceptors is moderate) with vasodilating properties conferred on the α-receptor blockade. The molecular structure has one chiral center, so the drug exists as two enantiomers. Full article

Josyane Márcia Vasconcelos Alves1,2 Livia Deris Prado3 Helvécio Vinícius Antunes Rocha2,3
1Medquímica Indústria Farmacêutica, Juiz de Fora, Brasil.
2Programa de Pós-Graduação Profissional em Gestão, Pesquisa e Desenvolvimento na Indústria Farmacêutica, Farmanguinhos, FIOCRUZ, Rio de Janeiro, RJ, Brasil.
3Laboratório de Micro e Nanotecnologia, Farmanguinhos, FIOCRUZ, Rio de Janeiro, RJ, Brasil.
Assessment of Physicochemical Properties and Comparison of Dissolution Profiles of Metformin Hydrochloride Tablets in Saudi Arabia

Although prevalence of substandard or counterfeit drugs is a world-wide problem, poor and developing countries are affected the most. To be a quality product, drug formulation must comply with certain standards. Consequently, in this study, metformin hydrochloride (MH) tablets... Full article

Mohammed Al Bratty1 Hassan A. Alhazmi1,2 Md Shamsher Alam1 Md Intakhab Alam3 Sadique A. Javed1 Nawazish Alam4
1Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
2Substance Abuse Research Centre, Jazan University, Jazan, Saudi Arabia.
3Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Saudi Arabia.
4Department of Clinical Pharmacy, College of Pharmacy, Jazan University, Saudi Arabia.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth R. Marques, Ph.D.1 Mark Liddell, Ph.D.1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Dissolution Systems Source Book: The eSource for Dissolution Products

Agilent has just released its 2020/2021 Dissolution Systems product catalog, or Source Book. If you’d like to reserve a physical copy, please contact your Agilent sales representative and request 5994-1101EN for an English version. You can also download a PDF copy by going to Agilent.com and entering the 5994-1101EN in the search field. Full article

Distek, Inc. Awarded Prestigious IDEA Bronze Trophy for BIOne 1250 Bioprocess Control System

North Brunswick, NJ - Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry for over 40 years, along with our industrial design partner - Phase One Design, has been awarded the IDEA (International Design Excellence Awards) Bronze trophy for the BIOne 1250 Bioprocess Control System... Full article

LOGAN INSTRUMENTS Launched THE PERMETRO SYSTEMS in International Markets

Following on the recent debut of its PERMETRO system - a dissolution and permeation all-in-one automated testing system at AAPS in San Antonio, USA, LOGAN INSTRUMENTS CORP has announced PERMETRO available globally for all customers... Full article

Simulations Plus Partners with Large Pharmaceutical Company to Develop the Virtual Bioequivalence Trial Simulator Module

LANCASTER, Calif.-- Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence (BE) Trial Simulator™ in GastroPlus®. Full article

Simulations Plus Partners with Large Pharmaceutical Company to Enhance the Mechanistic Oral Absorption (ACAT) Model in GastroPlus

LANCASTER, Calif.--Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, announced that it has entered into a new funded collaboration with a large pharmaceutical company to modify the mechanistic oral absorption (ACAT™) model in GastroPlus® to support gastrointestinal disease research. Full article

Innovative - Compliant - Trusted: Copley Marks a New Decade with a Major Rebrand and New Product Range

Nottingham, UK: Copley Scientific, a company renowned for high quality pharmaceutical testing equipment, begins the decade with a major rebrand complete with a new brand promise - Innovative - Compliant - Trusted - to capture the defining characteristics of Copley products. Full article

Driving Prediction Forward: SOTAX Announces Partnership with Triskelion for In-vivo Predictive Dissolution Testing

Regulatory support continues to grow for a biorelevent dissolution test that better represents in-vivo performance. In order to support this initiative, SOTAX and Triskelion have signed a partnership agreement whereby SOTAX will be the sales and service provider for Triskeli-on’s unparalleled TIM gastrointestinal simulation technology in the Americas. Full article


November 2019 volume 26 issue 4

Comment on the Importance of Documenting Drug Solubility Measurement Methodology, Including Characterizing the Physical Form of the Solute, for Meaningful Understanding, Interpretation, and Reporting of Solubility Data

This commentary continues the discussion initiated in a previous article entitled “Comment on the Importance of Data Transparency, Openness, and Reproducibility in Dissolution Science and Technology”. Full article

William E. Brown1 Vivian A. Gray2 Johannes Krämer3 John W. Mauger4 Kevin S. Warner5
1USP, Rockville, MD, USA.
2V.A. Gray Consulting, Hockessin, DE, USA.
3Disso GmbH, Homburg, Germany.
4Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah College of Pharmacy, Salt Lake City, UT, USA.
5Alucent Biomedical, Salt Lake City, UT, USA.
Comparison of In Vitro Release Rates of Diclofenac Topical Formulations Using an In-Line Cell Automated Diffusion System

The in vitro release test (IVRT) is a powerful tool for prediction of the impact of formulation excipients on the drug release profile as well as lot-to-lot uniformity. We have determined and compared the release profile of diclofenac... Full article

Yogesh Upadhyay1 Abhishek Kumar Singh1 Sanjeev Mishra1 Sanjay Jagannath Gurule1 Arshad H. Khuroo1 Neeta Tiwari2 Simrata Bedi2
1Department of Clinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Ltd., Gurugram, Haryana, India.
2Department of Product Development and Research, Sun Pharmaceutical Industries Ltd., Gurugram, Haryana, India.
Effect of Thyme Oil on the Transdermal Permeation of Pseudoephedrine HCl from Topical Gel

The aims of the current study were to prepare pseudoephedrine gel formulations for skin permeability and to assess the effect of thyme oil on the permeability of the formulations. Thyme oil was used in the gel formulations at a range of concentrations (0-3%) and its effects on pseudoephedrine permeation profiles in vitro were observed. Full article

Rahman Gul1,2 Syed Umer Jan2 Amanullah Khan1 Nusrat Jahan3 Rehana Rahman4 Samiullah Sherani1 Nabeela Tariq4
1Department of Health, Government of Balochistan, Pakistan.
2Faculty of Pharmacy and Health Sciences, University of Balochistan, Pakistan.
3Balochistan University of Information Technology, Engineering and Management Sciences, Quetta, Pakistan.
4Sardar Bahadur Khan Women's University, Quetta, Pakistan.
Real-Time Monitoring of Nicotine Release Behavior from Smokeless Tobacco (Snus) Based on Fiber Optic Sensing Technology

Introduction: To strengthen the safety control of smokeless tobacco (snus) products, an accurate method to test the nicotine release behavior from snus is very necessary. Methods: A laboratory-made flow-through device was designed to simulate snus using condition in the mouth, which was integrated with a commercial drug dissolution analyzer. Full article

Peng Li1 Shitong Zeng1 Jianxun Zhang1 Yi Shen2 Shihao Sun1 Yongli Zong1 Jianping Xie1 Dingzhong Wang1 Jing Yang2
1Zhengzhou Tobacco Research Institute of China National Tobacco Corporation, Zhengzhou, China.
2Shanghai New Tobacco Product Research Institute, Shanghai, China.
Pharmaceutical Equivalence and Stability of Furosemide Tablets in Argentina

Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. Full article

Marta I.V. Brevedan1 María A. Varillas1 Noelia L. Gonzalez Vidal1,2
1Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahia Blanca, Argentina.
2Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Bahía Blanca, Argentina.
Highlights from the 2018 Pharm Sci AAPS Annual Meeting in Washington DC

The American Association of Pharmaceutical Scientists (AAPS) held its Annual Meeting and Exposition at the Convention Center in Washington DC, November 4-7, 2018. Pre-conference workshops and short courses took place November 3-4, 2018. The meeting is a premier gathering of pharmaceutical scientists from around the world. Full article

Nikoletta Fotaki1 Johannes Krämer2 Dorys Diaz3
1Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.
2DISSO GmbH, Homburg, Germany.
3Global Chemistry, Manufacturing and Controls, Pfizer Inc., Groton, CT, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Just Released! 2020-2021 Agilent Dissolution Source Book

The updated catalog includes all the Agilent dissolution apparatus, sampling instrumentation, accessories, and online UV systems as well as qualification tools. Full article

Distek Opt-Diss Fiber Optic Dissolution System: Now Shipping with Windows 10

North Brunswick, NJ - Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry has just released a software upgrade for the Opt-Diss - Fiber Optic UV System for Dissolution Testing... Full article

Logan Instruments Officially Debuts: The PERMETRO

Logan Instrument’s new PERMETRO system is a dissolution and permeation all-in-one automated testing system. The PERMETRO system delivers dissolution and permeation results simultaneously. Full article

40 Years of Pharma Test

Pharma Test has turned 40 in 2019! The company was founded by Franz J. Fähler (pictured below) in 1979 in Hainburg, a district of Offenbach in the center of Germany. Through his previous sales activities in the drug quality control testing industry he recognized the potential in this growing market. The company is now a worldwide leader in high-quality testing equipment used in pharmaceutical, food, and cosmetics industries. Full article


August 2019 volume 26 issue 3

Dissolution Universal Strategy Tool (DUST): A Tool to Guide Dissolution Method Development Strategy

Development of a dissolution method with suitable acceptance criteria is a key part of any oral drug products control strategy. As a key quality control test linked to safety and efficacy, dissolution strategy is often subject to extensive discussion during product development and with regulatory authorities during filing of the marketing application. Full article

Talia Flanagan1,2 James Mann1
1Pharmaceutical Technology and Development, AstraZeneca, Macclesfield, Cheshire, UK.
2Present: UCB Pharma SA, Product Development, Chemin du Foriest, Belgium.
Physiologically Based Pharmacokinetic (PBPK) Modelling for In Vitro-In Vivo Extrapolation: Emphasis on the Use of Dissolution Data

Recently the pharmaceutical sector has witnessed a drastic rise in the advancement and incorporation of computerbased technology into several unit operations. Drug dissolution profiling is an important consideration for the successful development of immediate and extended orally delivered formulations. Full article

Vivek M. Ghate1 Pinal Chaudhari1 Shaila A. Lewis1
1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.
In Vitro Performance Testing of Nanoparticulate Drug Products for Parenteral Administration

The parenteral administration route is most effective for the delivery of drug substances with poor oral bioavailability. Nanoparticulate drug delivery systems were developed with the specific purpose of overcoming the obstacles met by conventional drug therapy for parenteral administration in case of drug targeting or passing biobarriers. Full article

Elena Fecioru1,2 Martin Klein1 Johannes Krämer3 Matthias G. Wacker4
1PHAST Development GmbH & Co. KG, Konstanz, Germany.
2Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.
3DISSO GmbH, Homburg, Germany.
4Department of Pharmacy, National University of Singapore, Singapore.
Workshop Report: USP Workshop on Exploring the Science of Drug Absorption

In October 2018, the United States Pharmacopeia (USP) hosted a two-day workshop to explore the science of drug absorption. Experts from around the globe presented some of the challenges associated with drug product development from the perspective of the physiological attributes of the patient (human or canine) and the body site for drug activity. Full article

Marilyn N. Martinez1 Sid Bhoopathy2 Sara Carlert3 Murat Cirit4 Raafat Fahmy1 Talia Flanagan5 Ben Forbes6 Masoud Jamei7 Mansoor A. Khan8 Viera Lukacova9 Jonathan P. Mochel10 Xavier Pepin11 Devendra Pade7 Christos Reppas12 Patrick J. Sinko13 David Sperry14 Konstantin Tsinman15 Maria Vertzoni12
1United States Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD, USA.
2Absorption Systems, Exton, PA, USA.
3AstraZeneca, Gothenburg, Sweden.
4Massachusetts Institute of Technology, Cambridge, MA, USA.
5Previously: Research and Development, AstraZeneca, Macclesfield, Cheshire, UK; Present: UCB Pharma SA, Product Development, Chemin du Foriest, Belgium.
6Institute of Pharmaceutical Science, King’s College London, London, UK.
7Certara UK Limited (Simcyp Division), Sheffield, UK.
8Rangel College of Pharmacy, Texas A&M University, College Station, TX, USA.
9Simulation Sciences, Simulations Plus, Inc., Lancaster, CA, USA.
10Iowa State University College of Veterinary Medicine, Ames, IA, USA.
11AstraZeneca, Macclesfield, UK.
12Department of Pharmacy, National and Kapodistrian University of Athens, Athens ,Greece.
13Ernest Mario School of Pharmacy, Rutgers University, The State University of New Jersey, Piscataway, NJ, USA.
14Small Molecule Design & Development, Eli Lilly and Company, Indianapolis, IN, USA.
15Pion Inc., Billerica, MA, USA.
Technical Note: Comparison of USP Apparatus 5 and 7 for In Vitro Drug Release from Nicotine Transdermal Systems

To monitor in vitro drug release in nicotine transdermal systems, USP Apparatus 5 (paddle over disc) and Apparatus 7 (reciprocating holder) were selected for comparison. Two nicotine transdermal systems marketed in United States for the controlled release of 7.0 mg of nicotine in a 72-hour period were evaluated. The results demonstrate that the drug release profiles obtained using USP Apparatus 5 and 7 are equivalent. Repeatability was measured using Apparatus 7 and found acceptable. Full article

Ming Li1 Hock Tan2
1Logan Instruments Corp., Somerset, NJ, USA.
2Bionex Pharmaceuticals, North Brunswick, NJ, USA.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Official Inaugural Ceremony of ERWEKA’s new Headquarters

Highest quality, state-of-the art production, modern open space offices and sustainable thinking. Full article

Pharma Test announces a New Automatic Solution for the “Half-Change” Test of Delayed Release Dosage Forms

Pharma Test has developed the new PTWS 820-MA, the first dissolution testing instrument with media addition system for the automatic testing of delayed release dosage forms. Full article

Agilent Opens Recalibration Center for 280-DS in Chengdu, China

For over a decade there has been a growing trend within the dissolution community to move to Mechanical Qualification (MQ), away from the traditional use of chemical “calibrators.” The primary impetus behind this change is the ability to easily qualify dissolution equipment on a shorter interval... Full article

PMDA Adds Licenses of GastroPlus®

Japanese government organization to train reviewers to efficiently analyze PBPK model submissions. Full article

Logan Instruments Announces New Dissolution/ Permeation System for Next Generation Dissolution Testing

Logan Instruments announces a new next-generation dissolution-permeation test system, a revolutionary advancement in dissolution testing. The fully automated PERMETRO system delivers dissolution and permeation results simultaneously. Full article

EAS 2019 - Enhancing Analytical Chemistry with Sustainable Solutions

November 18-20, 2019 Crowne Plaza Princeton Conference Center, Plainsboro, NJ Full article


May 2019 volume 26 issue 2

Stability of Biorelevant Media Under Various Storage Conditions

The physical and chemical stability of various biorelevant media (FaSSGF, FaSSIF V1, FaSSIF V2, FaSSIF V3, and FeSSIF) were investigated over periods after preparation of up to 120 h at room temperature (RT) (22 °C) and 37 °C. Full article

Lukas Klumpp1 Kalpa Nagasekar1 Orla McCullough2 Anja Seybert3 Mukul Ashtikar4 Jennifer Dressman1
1Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany
2Biorelevant.com Ltd, 41 New Road, London, UK
3Buchmann Institute for Molecular Life Sciences, Goethe University, Frankfurt am Main, Germany
4Fraunhofer Institute for Molecular Biology and Applied Ecology, Branch Translational Medicinal Pharmacology, Frankfurt am Main, Germany
Design of an Innovative Advanced Gastric Simulator

This paper presents a newly developed innovative dissolution apparatus with the ability to combine a special pattern of movement, closely mimicking the peristaltic contractions of the human stomach, and the gastric emptying process. Full article

Melita Hribar1 Jurij Trontelj1 Sandra Berglez2 Alenka Bevc2 Lovro Kuščer3 Janez Diaci3 Igor Legen2
1University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia
2Lek Pharmaceuticals d.d., Ljubljana, Slovenia
3University of Ljubljana, Faculty of Mechanical Engineering, Ljubljana, Slovenia
Determination of Dissolution Profile and Bioaccessibility of Ketosteril Using an Advanced Gastrointestinal In Vitro Model

Ketosteril is an originator drug prescribed for nutrition therapy for patients with chronic kidney disease (CKD). Ketoanalogues (KAs) of amino acids are part of the active pharmaceutical ingredients in the Ketosteril film-coated tablets. Full article

Edmundo Brito-de la Fuente1 Sébastien Secouard1 Nadja Siegert1 Francina Payeras Perelló1 Crispulo Gallegos1
1Product and Process Engineering Center, Global Manufacturing Pharmaceuticals, Pharmaceuticals Division, Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany
Development of Analytical Method for In Vitro Release Testing of Dexamethasone Nanosuspensions

The aim of this study was to develop and compare analytical methods for in vitro release testing (IVRT) of an active substance, dexamethasone, from nanosuspension using three apparatuses for IVRT of topical formulations... Full article

Antonia Šutić1 Marieta Duvnjak Romić2 Sandra Miočić2 Biserka Cetina-či?mek2
1Faculty of Pharmacy and Biochemistry University of Zagreb, Zagreb, Croatia
2PLIVA Croatia Ltd., Research and Development, Zagreb, Croatia
Accelerated Dissolution Method to Facilitate In Vitro Evaluation of Risperidone-Containing Microspheres

Microspheres have gained much interest because of their simple and controllable manufacturing process, sustainedrelease profile, and drug stabilization. However, the in vitro dissolution test of sustained-release microspheres is time consuming and impedes the development and quality control of microsphere products. Full article

Cheng Ma1 Han Fu2 Zhengwei Huang1 Xiangyu Ma3 Yang Liu4 Wenhua Wang1 Mingjun Wu1 Xuejuan Zhang1,51,5 Ying Huang1 Chuanbin Wu1
1School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, China
2Shenzhen Center for Chronic Disease Control, Shenzhen, China
3College of Pharmacy, Molecular Pharmaceutics and Drug Delivery, The University of Texas at Austin, Austin, TX, USA
4Chongqing Medical and Pharmaceutical College, Chongqing, China
5Institute for Biomedical and Pharmaceutical Sciences, Guangdong University of Technology, Guangzhou, China
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Distek, Inc. Releases Dual Impeller BIOne Single-Use Bioreactor System

North Brunswick, NJ - Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry has added a Dual Impeller Single-Use Bioreactor (SUB) System to our BIOne portfolio. Full article

Permetro System: Solving Your BE and IVIVC Needs

ARLI Logan Instruments sets its sights on revolutionizing the world of bioequivalence (BE) and in-vitro and in-vivo correlation (IVIVC) studies with the Permetro system. Full article

Are You a Member of the Dissolution Community?

Agilent is committed to providing you with all the information you need to use and maintain our equipment. As a result, we’ve created an Agilent Dissolution Community accessible from Agilent.com. Full article


February 2019 volume 26 issue 1

The Critical Role of the USP Performance Verification Test in Dissolution Testing and Qualification of the Paddle Apparatus

Performance qualification of the United States Pharmacopeia (USP) paddle apparatus (USP apparatus 2), as described in USP General Chapter <711> Dissolution, requires a demonstration of the dissolution behavior of a standard material as well as control of the mechanically measurable parameters of the apparatus. Full article

Will Brown1 Satish Perivilli1 Doug Podolsky1 Erika S. Stippler1 Steven Walfish1
1USP, Rockville, MD, USA
Primer on the Science of In Vitro Dissolution Testing of Oral Dosage Forms and Factors Influencing its Biological Relevance

In vitro dissolution testing can serve as an effective and efficient tool for evaluating the influence of formulation and manufacturing variables on drug release characteristics. The targeted purpose will determine the method used and the implications of the test results. Full article

Raafat Fahmy1 Marilyn N. Martinez1
1Office of New Animal Drug Evaluation, Center for Veterinary Medicine, U.S. Food and Drug Administration, Rockville, MD, USA
Dissolution-Controlled Salt of Pramipexole for Parenteral Administration: In Vitro Assessment and Mathematical Modeling

Parenteral suspensions of poorly water-soluble salts for intramuscular administration retain therapeutic drug concentration over a long duration. In vitro drug dissolution testing is a prerequisite to assess batch-to-batch variability as well as to assure appropriate drug release during formulation development. Full article

Chaudhary Komal1 Bhayani Dhara1 Shah Sandeep2 Dharmadhikari Shantanu2 Mehta J Priti1
1Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
2Erweka India Private Limited, Ahmedabad, Gujarat, India
In vitro Characterization and Evaluation of Commercialized Paracetamol Products in Jordan

Paracetamol (acetaminophen) is one of the most commonly used antipyretic and analgesic drugs worldwide. It is the drug of choice for patients with bronchial asthma, hemophilia, salicylate hypersensitivity, peptic ulcer, and pregnant or breastfeeding women who cannot be treated with nonsteroidal anti-inflammatory drugs. Full article

Ola A. Tarawneh1 Atif M Madi2 Rania Hamed1 Rania Qirem1 Walid Qerem1 Ala Alhusban1 Suhair Sunoqrot1 Nouf Mahmoud1 Samah Ata1 Iyad Alsheikh1
1Al-Zaytoonah University of Jordan, Faculty of Pharmacy, Amman, Jordan
2Trinity College Dublin, School of Pharmacy and Pharmaceutical Sciences, Dublin, Ireland
Discriminatory Dissolution Testing for Liquisolid Compacts Containing a Poorly Water-Soluble Drug (Hydrochlorothiazide)

Drug release from liquisolid compacts is dependent on several variables and changes in experimental parameters, like drug loading and the type and quantity of the carrier material, which affect the dissolution rate, significantly. Therefore, a dissolution method is needed that can discriminate among... Full article

Amjad Khan1 Zafar Iqbal2 Aman Ullah3 Ibrahim Khadra4 Mehrin Sherazi3 Noreen Zeb3
1Department of Pharmacy, Kohat University of Science and Technology, Kohat, Pakistan
2Department of Pharmacy, University of Peshawar, Peshawar, Pakistan
3Department of Pharmacy, Abasyn University, Peshawar, Pakistan
4Strathclyde Institute of Pharmacy and Biomedical Sciences, Glasgow, UK
In Vitro Dissolution Testing to Assess Pharmaceutical Equivalence of Selected Amoxicillin Products Available in Sri Lanka: A Post-Marketing Study

Guidance documents on biowaivers and published literature, including the biowaiver monograph on amoxicillin, recommend conducting biopharmaceutics classification system (BCS)-based in vitro dissolution studies as a surrogate for in vivo bioequivalence (BE) studies for solid oral amoxicillin products. Full article

Dhanusha Thambavita1 Charith M. Jayathilake1 K. D. Darshi Sandamali1 Priyadarshani Galappatthy1 Raveendra Laal Jayakody1
1Department of Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Sri Lanka
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

In New Study, Pion and Genentech Demonstrate Effective In Vitro Prediction of Drug-Drug Interactions with Acid Reducing Agents

Pion and Genentech (San Francisco, CA) announce publication of a collaborative research paper entitled, “Using pH Gradient Dissolution with In-Situ Flux Measurement to Evaluate Bioavailability and DDI for Formulated Poorly Soluble Drug Products,” in the September 12 online issue of AAPS PharmSciTech. Full article

Vinod P. Shah, Ph.D. Recognized by AAPS for Global Leadership

ARLINGTON, VA (October 23) - It is with great pleasure that the American Association of Pharmaceutical Scientists announces our Global Leader award honoree, Vinod P. Shah, Ph.D., of VPS Consulting, LLC. and formerly with the US Food and Drug Administration. Full article

USP Offers Dissolution Track for the New Certificate of Pharmacopeial Quality Assessment

Available for the first time, the new USP Certificate of Pharmacopeial Quality Assessment offers a comprehensive online program that highlights knowledge and skills necessary for quality assessment professionals to be successful in their function. Full article

The 400-DS Just Got Even Better

The 400-DS, a modified but compendial Apparatus 7, was initially developed to test drug-eluting stents under accelerated conditions. It has been used to test many other products that require ultralow volumes in the 5-10 mL range. To maintain sample integrity with these ultralow volumes, the 400-DS offers full control over evaporative losses. Full article

Simulations Plus Releases DDDPlus™ Version 6

New models for in vitro systems lead to improved inputs for GastroPlus® simulations Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, announces the release of version 6 of its in vitro dissolution modeling software, DDDPlus™. Full article

Logan Launches New Instruments to Kickoff 2019

Logan Instruments anticipates continued growth in 2019 with even more innovation to its already diversified product line. These improvements can be seen across their dissolution and skin diffusion instruments. Full article


November 2018 volume 25 issue 4

Commentary: Concerns Regarding FDA Guidance on Dissolution Testing

Concerns have been raised regarding the recent US Food and Drug Administration (FDA) guidance on dissolution testing. I share these apprehensions here and welcome any additional information or comments you may have on this topic. Full article

Alger Salt1
1Sal Mea Consulting, Durham, NC, USA
In Vitro Release Test Methods for Drug Formulations for Parenteral Applications

In vitro drug release testing for parenteral drug formulations could benefit from more regulatory guidance and compendial information as this testing is a part of current expectations for drug product approval. This Stimuli article discusses in vitro drug release methods for those parenteral drug formulations that are not solutions and explores the challenges involved in using these methods for each formulation type. Full article

Vivian Gray1 Susan Cady2 David Curran3 James DeMuth4 Okponanabofa Eradiri5 Munir Hussain6 Johannes Krämer7 John Shabushnig8 Erika Stippler9,10
1V. A. Gray Consulting, Inc, Hockessin, DE
2Boehringer Ingelheim Animal Health, North Brunswick, NJ
3GlaxoSmithKline R&D, King of Prussia, PA
4University of Wisconsin, Madison, WI
5Food and Drug Administration, Silver Spring, MD.—The views presented in this article do not necessarily reflect those of the FDA. No official support or endorsement by the Food and Drug Administration is intended or should be inferred.
6Bristol-Myers Squibb Company, New Brunswick, NJ. (Retired)
7PHAST, Homburg, Germany
8Insight Pharma Consulting, LLC, Marshall, MI
9United States Pharmacopeia, Rockville, MD
10Correspondence should be addressed to: Desmond G Hunt, Principal Scientific Liaison, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel: +1.301.816.8341; email: dgh@usp.org
In Silico Simulation of Dissolution Profiles for Development of Extended-Release Doxazosin Tablets

Developing extended-release (ER) formulations with appropriate release characteristics can be challenging for formulation scientists. The aim of this study was to demonstrate the use of computer-simulated dissolution profiles associated with statistical experimental design in the development of doxazosin ER tablet formulations... Full article

Marcelo Dutra Duque1,2 Michele Georges Issa1 Daniela Amaral Silva1,3 Eduardo José Barbosa1 Raimar Löbenberg3 Humberto Gomes Ferraz1
1Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo - USP, São Paulo, Brazil
2Department of Pharmaceutical Sciences, Institute of Environmental, Chemical and Pharmaceutical Sciences, Universidade Federal de São Paulo - UNIFESP, Diadema, Brazil
3Faculty of Pharmacy and Pharmaceutical Sciences, Centre for Pharmacy and Health Research, University of Alberta, Edmonton, AB, Canada
Pharmaceutical Equivalence of Hydrochlorothiazide Tablets in Argentina

Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market.. Full article

María A. Varillas1 Marta I.V. Brevedan1 Noelia L. Gonzalez Vidal1,2
1Medicine Quality Control, Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, Bahía Blanca, Argentina
2CONICET-UNS, Bahía Blanca, Argentina
A Novel Kinetic Model for Dissolution of Herbal Medicine

To establish a novel kinetic model for phytochemical constituent dissolution, including comparison of results of open and closed dissolution systems, Buyanghuanwu decoction (BYHWD), a traditional Chinese herbal medicine formula, was selected as our experiment subject... Full article

Yu-Tian Zhang1 Wen-Long Liu1,2,3 Yu Tang1 Yan-Tao Yang1,2,3 Mei-Feng Xiao1,2,3 Yi-Qun Zhou1,2,3 Jin Zhou1,2,3 Fu-Yuan He1,2,3
1Pharmacy College, Hunan University of Chinese Medicine, Changsha, China
2Hunan Key Laboratory of Druggability and Preparation Modification for Traditional Chinese Medicine, Changsha, China
3Department of Supramolecular Mechanism and Mathematic-Physics Characterization for Chinese Materia Medicine, Changsha, China
Evaluation of the Discriminatory Power of USP Dissolution Method for Candesartan Cilexetil Tablets through Testing of Marketed Products in Egypt

The development of dissolution testing conditions for drugs exhibiting low aqueous solubility like candesartan cilexetil is a challenging task for pharmaceutical scientists and regulatory organizations. The purpose of this study was to evaluate the discriminatory power of the dissolution testing medium... Full article

Ahmed M. Amer1 Ahmed N. Allam2,3 Ossama Y. Abdallah2
1Research and Development Department, Pharo Pharma Company, Alexandria, Egypt
2Department of Pharmaceutics, Faculty of Pharmacy, Alexandria, Egypt
3Department of Pharmaceutics and Pharmacy Practice, Ministry of Health, Muscat, Oman
3D Printing for Fast Prototyping of Pharmaceutical Dissolution Testing Equipment for Nonstandard Applications

Purpose of the research was to assess feasibility of fused deposition techniques (3D printing) for development of analytical equipment dedicated for specific dosage forms and for nonstandard applications. Dissolution profiles as well as 3D magnetic resonance imaging (MRI) of the buccal tablets during hydration in dissolution medium were analyzed.. Full article

Przemysław Dorożyński1 Witold Jamróz2 Władysław P. Węglarz3 Wojciech Kulinowski4 Mateusz Zaborowski2 Piotr Kulinowski4
1Pharmaceutical Research Institute, Warszawa, Poland
2Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Kraków, Poland
3Department of Magnetic Resonance Imaging, Institute of Nuclear Physics, Polish Academy of Sciences, Kraków, Poland
4Department of Mathematics, Physics and Technical Science, Institute of Technology, Pedagogical University of Cracow, Kraków, Poland
A Comparative Study of Propranolol Release by In Vitro Dissolution Profiles in Pharmaceutical Formulations

Propranolol is a β-blocker used to modify or restore normal heart rhythm in cardiovascular diseases. The aim of this study was to compare the dissolution profiles of 40-mg tablets of propranolol available as a reference, generic, and similar drug product, sold commercially in Bahia, Brazil, using a sensitive and rapid ultraviolet spectrophotometric method... Full article

Adenilson P. Conceição1 Ramon R. Sá1 Vagner C. da Silva1 Matheus da S. Ferreira2 Edith C. L. Cazedey3 Hemerson I. F. Magalhães4 Aníbal de F. Santos Júnior1,2
1Department of Life Sciences, Universidade do Estado da Bahia, 41195-001, Salvador, Bahia, Brazil
2Department of Exacts and Earth Sciences, Universidade do Estado da Bahia, Salvador, Bahia, Brazil
3College of Pharmacy, Universidade Federal da Bahia, Campus Ondina, Salvador, Bahia, Brazil
4Departament of Pharmaceutical Sciences, Universidade Federal da Paraíba (UFPB),Campus Universitário, João Pessoa, Paraíba, Brazil
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

New Vertical Diffusion Cell from Copley Scientific extends options for topical semisolids and transdermal testing

Copley Scientific, a leading manufacturer of laboratory testing equipment, has introduced a new Vertical Diffusion Cell (VDC) for efficient in vitro skin permeation studies. The VDC will find application in R&D in chemical, pharmaceutical, cosmetics, and other industries. Full article

Protect Your Accessories!

Agilent has recently introduced a new way to ship and store your dissolution accessories. Effective now, when you order one of the 6-packs of accessories shown below, they will be shipped in a reusable plastic container with pre-cut inserts to safely secure your accessories. Full article

Simulations Plus Releases ADMET Predictor™ Version 9

Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, announced that it has released version 9 of its flagship artificial intelligence (AI) modeling program, ADMET Predictor™. Full article

Simulations Plus Receives New Grant Award and Extends Funded Research Collaboration with the FDA

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, is pleased to announce that it has received notices of two awards from the U.S. Food and Drug Administration (FDA). Full article

Distek, Inc. Releases Small Volume Conversion Kit for Symphony 7100 Bathless Dissolution Tester

Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories and validation services for over 40 years, announced today the release of their small volume conversion kit for the symphony 7100 bathless dissolution tester... Full article

Distek, Inc. Awarded U.S. Patent for Single-Use Bioreactor Design

Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry for over 40 years, has been awarded U.S. Patent 10,059,914 for their single-use bioreactor design. Full article

Pharma Test and Fraunhofer IME Announce the Dispersion Releaser - a Solid Testing Apparatus for Nano- and Microformulations

Hainburg, Germany: The Fraunhofer Institute for Molecular Biology and Applied Ecology IME together with the Goethe University Frankfurt/Main and Pharma Test have developed the new Dispersion Releaser (PT-DR) apparatus for a standard dissolution tester... Full article

EAS 2018 - Analytical Solutions to the World’s Problems

The theme of the 2018 Eastern Analytical Symposium (EAS) and Exposition is “Analytical Solutions to the World’s Problems”. The EAS has been about problem-solving. The EAS program this year offers a multitude of analytical solutions to the problems of our world... Full article

AAPS Recognizes Excellence in Publishing with Three Manuscript Awards

The American Association of Pharmaceutical Scientists (AAPS) recognizes three award-winning manuscripts from three research journals: The AAPS Journal, AAPS PharmSciTech, and Pharmaceutical Research. Full article

AAPS Honors Diane J. Burgess with Dale E. Wurster Research Award

The American Association of Pharmaceutical Scientists (AAPS) is extremely pleased to bestow Diane Burgess, PhD, FAAPS, with the honor of receiving the AAPS Dale E. Wurster Research Award in Pharmaceutics, for her decades of significant contributions to pharmaceutical research. Full article

Dissolution Compliance with Agilent Workstation Software for Windows 10 is Ready

The Agilent Dissolution Workstation Software version A.01.05 is available as your compliant solution for Windows 10 environments. This software powers the traditional USP apparatus 1/2/3/5/6/7 instruments from Agilent as well as the 400-DS small volume apparatus 7 and 280-DS... Full article

Logan Instruments Exclaims, “Enter the Dragon!”

The Chinese Zodiac calendar may be looking at 2019 as the year of the Pig, but Logan Instruments sees it differently. They are proudly launching a state-of-the-art sampling system set to revolutionize the industry. With a robotic sampling arm, the Dragon 12... Full article

In New Study, Pion and Genentech Demonstrate Effective In Vitro Prediction of Drug-Drug Interactions with Acid Reducing Agents

Pion and Genentech (San Francisco, CA) announce publication of a collaborative research paper entitled, “Using pH Gradient Dissolution with In-Situ Flux Measurement to Evaluate Bioavailability and DDI for Formulated Poorly Soluble Drug Products,” in the September 12 online issue of AAPS PharmSciTech. Full article


August 2018 volume 25 issue 3

Special Edition of Review Articles

Towards Standardized Dissolution Techniques for In Vitro Performance Testing of Dry Powder Inhalers

The pulmonary route of administration is used for both locally and systemically acting drugs. However, knowledge gaps about the fate of aerosol particles after deposition in the lung provide room for future elucidation. During pharmaceutical development as well as in quality control of oral inhalation products... Full article

Andreea Floroiu1,2 Martin Klein1 Johannes Krämer1 Claus-Michael Lehr2, 32,3
1Eurofins - PHAST Development GmbH & Co. KG, Konstanz, Germany
2Department of Biopharmaceutics and Pharmaceutical Technology, Saarland University, Saarbrücken, Germany
3Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Saarbrücken, Germany
In Vitro-In Vivo Correlation (IVIVC): From Current Achievements Towards the Future

Conventional in vitro-in vivo correlation (IVIVC) based on compendial dissolution testing faces many obstacles, among which are problems in establishing meaningful correlation for immediate release dosage forms, lack of intravenous data in cases of many drugs without a possibility to obtain a unit impulse response, and well-known difficulties to build an IVIVC model for BCS III and BCS IV class drugs. Full article

Paweł Konrad Tuszyński1 Jakub Szlęk1 Sebastian Polak2,3 Renata Jachowicz1 Aleksander Mendyk1
1Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Kraków, Poland
2Department of Social Pharmacy, Unit of Pharmacoepidemiology and Pharmacoeconomics, Jagiellonian University Medical College, Kraków, Poland
3Certara UK, Sheffield, UK
The Significance of Disintegration Testing in Pharmaceutical Development

Disintegration is a physical process related to the mechanical breakdown of a tablet or granulate particle into smaller particles. This review investigates disintegration mechanisms, pharmacopeial use of the disintegration test and scientific studies showing its utility and potential as a pharmaceutical performance test. Full article

Daniela Amaral Silva1 Gregory K Webster2 Nadia Bou-Chacra3 Raimar Löbenberg1
1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, AB, Canada
2Global Research and Development, AbbVie Inc., North Chicago, IL, USA
3Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, SP, Brazil
Simulated Genital Tract Fluids and Their Applicability in Drug Release/Dissolution Testing of Vaginal Dosage Forms

There has been a trend towards the development of novel vaginal dosage forms both for local therapy and systemic absorption. The growing number of vaginal dosage forms, however, presents with an increasing demand for appropriate in vitro test methods for ensuring a safe and reliable in vivo performance of each of the formulations... Full article

Katharina Tietz1 Sandra Klein1
1Center of Drug Absorption and Transport (C_DAT), Institute of Biopharmaceutics and Pharmaceutical Technology, Department of Pharmacy, University of Greifswald, Greifswald, Germany
In Vitro Release Testing Methodology and Variability with the Vertical Diffusion Cell (VDC)

In vitro release test (IVRT) using the vertical diffusion cell (VDC) is a well-established method to evaluate the performance of a topical dosage form and to better understand the physicochemical characteristics of the product. The VDC is the most frequently used apparatus to measure drug release from semisolid products... Full article

Ryan R. Klein1,2 Jenna L. Heckart1,3 Kailas D. Thakker1
1Tergus Pharma, Durham NC, USA
2Alliance Pharma, Malvern PA, USA
3Bioagilytix, Durham NC, USA
In Vitro Performance Testing of Medicated Chewing Gums

The oromucosal route of therapeutic administration can be targeted by medicated chewing gums (MCGs) loaded with locally or systemically acting active pharmaceutical ingredients (API). Compared to other dosage forms, release of the API is mainly determined and controlled by the patient’s mastication... Full article

Lisa Zieschang1,2 Martin Klein1 Johannes Krämer1 Maike Windbergs2,3
1Eurofins - PHAST Development, GmbH & Co. KG, Konstanz, Germany
2Institute of Pharmaceutical Technology and Buchmann Institute for Molecular Life Sciences, Goethe-University Frankfurt, Frankfurt, Germany
3PharmBioTec GmbH, Saarbruecken, Germany
In Situ UV Fiber Optics for Dissolution Testing - What, Why, and Where We Are After 30 Years

Ultraviolet (UV) fiber optic spectroscopy has been applied to dissolution testing for more than 30 years. Multiple types of instrumentation schemes have been designed and implemented over that time, all aimed to introduce UV light into the dissolution apparatus to perform in situ measurement of the percent dissolved of the active pharmaceutical ingredient (API)... Full article

Ishai Nir1 Xujin Lu2
1Distek, Inc. North Brunswick, NJ, USA
2Bristol Meyers Squibb, New Brunswick, NJ, USA
Dissolution Highlights from the 2017 AAPS Annual Meeting in San Diego

The American Association of Pharmaceutical Scientists (AAPS) held its Annual Meeting and Exposition at the Convention Center in San Diego, CA, November 12-15, 2017. Pre-conference workshops and short courses took place November 11-12, 2017. The meeting is a premier gathering of pharmaceutical scientists from around the world... Full article

Nikoletta Fotaki1 Johannes Krämer2 Xujin Lu3 Dorys Diaz4 Connie Langer4
1Department of Pharmacy and Pharmacology, University of Bath, Bath, UK
2Eurofins-PHAST, Konstanz, Germany
3Drug Product Science and Technology, Bristol-Myers Squibb, New York, NY, USA
4Global Chemistry, Manufacturing and Controls, Pfizer Inc., Groton, CT, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Dissolution Goes Mobile

For several years we have provided a Digital Dissolution Source Book. What make this version unique is it incorporates the detailed catalog information from our printed catalog along with embedded video as well as hyperlinks to posters, videos, brochures and white papers. Full article

Distek, Inc. Releases the PrepEngine Mini Sample Prep Station

Distek, Inc., an industry leader in pharmaceutical laboratory testing instruments, accessories and validation services, is excited to release the PrepEngine Mini Sample Prep Station for assay, impurity and content uniformity applications. Full article

ERWEKA Opens Subsidiary in the USA

ERWEKA, a premium manufacturer of tablet test equipment for the pharmaceutical industry, has established a subsidiary in the United States as of July 1st, 2018. The subsidiary, named ERWEKA America Inc. will be headquartered in Edison, New Jersey and will include a showroom, service area, and testing laboratory. Full article

Logan Instruments: Tip of the Iceberg

As Logan has proven year after year for nearly thirty years, going that extra mile to ensure a customer’s satisfaction will only lead to a positive experience that can be shared between customers privately as well as in a public forum like Dissolution Technologies. In the past few months... Full article

METTLER TOLEDO and SOTAX Partnership

METTLER TOLEDO announces a new partnership with SOTAX in the field of dissolution testing. SOTAX is a Swiss-based, leading manufacturer of equipment for dissolution testing of pharmaceutical dosage forms. Full article


May 2018 volume 25 issue 2

Comment on the Importance of Data Transparency, Openness, and Reproducibility in Dissolution Science and Technology

A recent editorial published in Science by Jeremy Berg emphasizes that “ideas supported by welldefined and clearly described methods and evidence are one of the cornerstones of science” (1). The broad importance of this topic is reflected by a current project entitled Reproducibility and Replicability... Full article

John W. Mauger1
1Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah College of Pharmacy, Salt Lake City, UT
Application of a Modified Disk for Testing Orally Disintegrating Tablets by USP <701>

The USP <701> basket-rack assembly with disks is applied to the disintegration testing of orally disintegrating tablets (ODTs). Although <701> is generally suitable for testing ODTs as described, interference arising from the physical interaction of the tablet and disk is observed for many ODTs. Full article

James Klancke, Pam Payne, and Craig Nordholm1
1CIMA Labs Inc., Minneapolis, MN, USA
Influence of Tablet Splitting on Dissolution of Tablets with Naproxen Sodium

The aim of this paper was to examine the impact of mechanical tablet splitting on in vitro dissolution of naproxen sodium. Naproxen (250 and 500 mg) was used in the experiment. The in vitro tests were conducted using the USP paddle apparatus. Full article

Dorota Wójcik-Pastuszka1 Kordian Juszkiewicz1 Gizem Özhan2 Witold Musiał1
1Department of Physical Chemistry, Wroclaw Medical University, Wroclaw, Poland
2Department of Pharmaceutical Technology, Ankara University, Ankara, Turkey
Film-Controlled Synchronized Release Multicomponent Preparations of Chinese Materia Medica for Oral Administration

Traditional Chinese medicine is mostly compound medicine, and its efficacy is achieved based on the action of multiple components and targets. The simultaneous release of multiple components is the focus of the modernization of traditional Chinese medicine. Full article

Xin Huang1 Yuqin Wen1 Qingchun Xie1 Lou Shen1 Bohong Guo1 Chaofeng Liang1,2 Yanzhong Chen1 Zhufen Lu1
1Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, China
2Guangzhou Pharmaceuticals Corporation, Guangzhou, China
Application of Biowaiver Methodology for a Post-Marketing Study of Generic and Brand Name Metronidazole Tablets

An important component of evaluation of generic medicines is assessing their therapeutic equivalence, which is done by a comparative study with an appropriate comparator, such as an in vivo bioequivalence study or an in vitro dissolution study. Full article

Dhanusha Thambavita1 Sanjeewani Fernando1,2 Priyadarshani Galappatthy1 Raveendra Jayakody1
1Department of Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Sri Lanka
2Department of Chemistry, Faculty of Science, University of Colombo, Sri Lanka
Formulation of Hedera helix L. in Topical Dosage Forms: In Vitro and Ex Vivo Evaluation

Hedera helix L. is traditional herbal medicine used in the treatment of asthma. The main objective of this study was to formulate a microemulsion, a gel, and an ointment containing the ethanol extracts of H. helix L. and to evaluate in vitro and ex vivo permeation. Full article

Rahman Gul1,2 Syed Umer Jan1 Mahmood Ahmad3 Muhammad Mukhtiar4
1Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan
2Department of Health, Government of Balochistan, Pakistan
3Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Punjab, Pakistan
4Department of Pharmacy, University of Poonch, Rawalakot, Azad Jammu and Kashmir, Pakistan
Summary of the In Vivo Predictive Dissolution (iPD) - Oral Drug Delivery (ODD) Conference 2018

During the in vivo predictive dissolution (iPD) - oral drug delivery (ODD) conference at Lake Tahoe from March 4-9, 2018, different speakers quoted the need of a biorelevant dissolution test to better reflect the intraluminal behavior of an oral drug product in the human gastrointestinal (GI) tract. Full article

Bart Hens1,2 Jozef Al-Gousous1 Kai Wang1 Niloufar Salehi3 Robert M. Ziff3 Yasuhiro Tsume1 Marival Bermejo1,4 Paulo Paixão1,5 James G. Brasseur6,7 Alex Yu1 Arjang Talattof1 Gail Benninghoff1 Peter Langguth8 Hans Lennernäs9 William L. Hasler10 Luca Marciani11 Duxin Sun1 Gregory E. Amidon1 Joseph Dickens12 Kerby Shedden12 Raimar Löbenberg13 Gordon L. Amidon1
1Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA
2Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium
3Center for the Study of Complex Systems and Department of Chemical Engineering, University of Michigan, Ann Arbor, MI, USA
4Department Engineering Pharmacy Section, Miguel Hernandez University, Alicante, Spain
5Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Lisboa, Portugal
6Department of Mechanical and Nuclear Engineering, Pennsylvania State University, University Park, PA, USA
7Department of Aerospace Engineering Sciences, University of Colorado Boulder, Boulder, CO, USA
8Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg University Mainz, Mainz, Germany
9Department of Pharmacy, Uppsala University, Uppsala, Sweden
10Department of Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA
11Nottingham Digestive Diseases Centre and 2NIHR Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom
12Department of Statistics, University of Michigan, Ann Arbor, MI, USA
13Faculty of Pharmacy & Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta, Canada
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Advancing the science of OINDPs: Copley Scientific joins IPAC-RS

Nottingham, UK: Copley Scientific, a global leader in the design and manufacture of inhaler testing equipment, is pleased to announce that it has joined the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) as an Associate Member. Full article

Copley Scientific Appoints Local Expert as Chief Operating Officer

Nottingham, UK: Following the recent expansion of its UK Headquarters, Copley Scientific is pleased to announce a new addition to its senior management team, in response to a record year for sales and the continued success of the business. Full article

IDIS software makes it easy to comply with USP Acceptance and Prednisone PVT Testing

New acceptance criteria functionality in IDIS allows users to configure rules and limits for USP Acceptance Tables A, B, S, and L. As tests are performed, using unique tracking and scheduling, data from different runs can be automatically combined and checked against set limits. Full article

Agilent’s Dissolution Workstation Goes Remote

As the need for a truly compliant solution in the lab grows, it’s important to consider new ideas and inspect the data gathering environment as a whole. Dissolution testing is often performed in an isolated setting - free from analytical instrumentation -and is regularly overlooked when it comes to data integrity. This can be a costly mistake. Full article

Hablas Español?

El curso de capacitación Dissolution 1-on-1 es el curso más completo de este tipo. Esta capacitación en línea y autodidacta es una adaptación de nuestro programa Fundamentals of Dissolution. Fue desarrollado para permitir que los químicos aprendan interactivamente a su propio ritmo. Los siete capítulos cubren todo, desde teoría hasta lecciones prácticas sobre cómo realizar una prueba real. Full article

Logan Instruments Demonstrates its Pillar of Innovation with Collaborative Project Initiatives

Logan Instruments’ 2018 is off to a great start, with consistent business focusing on one of the pillars of the organization: INNOVATION. This aspect of their business strategy is paramount in this industry. Full article

Teledyne Hanson Releases Phoenix Dry Heat Diffusion Cell Testing

Los Angeles, CA: Teledyne Hanson Research announced the release of the Phoenix™ family of dry-heat diffusion testing instruments. The Phoenix product line-up includes an advanced dry-heat diffusion cell, a compact six-cell manual sampling system, and a robotic platform capable of unattended testing of up to 24 diffusion cells at once. Full article

Simulations Plus Releases GastroPlus Version 9.6

Lancaster, CA: Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, has released version 9.6 of its flagship physiologically-based pharmacokinetic (PBPK) modeling program, GastroPlus™. Full article

Simulations Plus Launches Version 2.0 of PKPlus

Lancaster, CA: Simulations Plus, Inc. (NASDAQ: SLP), the premier provider of simulation and modeling software and consulting services for pharmaceutical development from earliest discovery through all phases of clinical trials, announced the launch of version 2.0 of PKPlus, a major update to its software for analysis of preclinical and clinical trial data. Full article


February 2018 volume 25 issue 1

Similar or Not? Comparison of Dissolution Profiles of Different Hydroxypropylmethyl Cellulose (HPMC) Capsules

The effect of using different HPMC hard capsule shells on the in vitro dissolution profile of acetaminophen powder was investigated. Use of HPMC capsule shells from different manufacturers resulted in different in vitro dissolution profiles. Full article

Jozef Al-Gousous1 Michael B. Bolger2 Fernando Diez3 Justin Kalafat3 Peter Langguth1 Dorene Almeida3 Jnanadeva Bhat3
1Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, Germany
2Simulations Plus Inc, Lancaster, CA, USA
3ACG World, Mumbai, India
Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient... Full article

María A. Varillas1 Marta I.V. Brevedan1 Gonzalez Vidal12
1Control de Calidad de Medicamentos, Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina
2CONICET-UNS, Bahía Blanca, Argentina
A New Model of a 3D-Printed Shell with Convex Drug Release Profile

The objective of this study was to fabricate a tablet with a convex drug release profile. A circumscribed sphere with a regular tetrahedron (pyramid) cavity shell model was created by a computer-aided design (CAD) program and printed by a 3D printer. Full article

Jingzhou Zhao1 Xiaowen Xu1 Maonan Wang1 Liang Wang2
1Central South University, Changsha 410083, China
2School of Medical Informatics, Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China
Mebeverine HCl and Aluminium/Magnesium Antacid Interactions: A Potential Impact on Electrolyte Replacement Therapy

When antacids are administered with other drugs, they can alter the absorption, bioavailability, and/or excretion of concomitantly administered drugs. This study aims to characterize the in vitro interaction between different formulations... Full article

Fadilah Sfouq Aleanizy1 Eram El Tahir1 Fulwah Yahia Alqahtani1 Omaimah Al Gohary1 Rania Al Shalabi2
1Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
2Pharmacy Department, King Faisal Specialist Hospital, Riyadh, Saudi Arabia
Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Lercanidipine hydrochloride (HCl) is L-type calcium channel blocker widely used in the management of hypertension. According to the BCS classification system, it is classified under BCS class II drugs, showing low solubility and high permeability. Full article

Farhatjahan Shaikh1 Vandana Patel1 Meenakshi Patel1 Naazneen Surti1
1Babaria Institute of Pharmacy, BITS Edu Campus, Varnama, Vadodara, Gujarat, India
Technical Note: Content Uniformity Measurement of an OTC Product Using a Dedicated Sample Preparation Station and a Fiber Optic UV Analysis System

Content uniformity (CU) is performed using a wide range of techniques for sample preparation and analysis. Most are based on existing laboratory tools such as ultrasonic cleaners, orbital shakers, magnetic stirrers, or homogenizers not specifically optimized for CU sample preparation. Full article

Andrew Kielt1 Ishai Nir1 Jeff Seely1
1Distek, Inc., North Brunswick, NJ
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Dissolution Discussion Group (DDG) - Online Meetings

The DDG website has been available since 1998 providing a bulletin board for the international dissolution community of scientists for free and interactive discussion on a multitude of topics. Agilent Technologies sponsors this worldwide... Full article

Reflecting on an Excellent Last Quarter and Looking Ahead to 2018

Logan Instruments saw 2017 close with a string of exciting opportunities and developments. In the middle of November, their biggest and most anticipated annual show (AAPS) was a huge success... Full article

Faster, More Reproducible Dry Powder Inhaler Testing — Copley Scientific Introduces TPK™ 2100 Critical Flow Controller

Nottingham, UK: Following a successful preview at the 2017 Respiratory Drug Delivery (RDD) Europe conference, Copley Scientific, the world’s leading manufacturer of inhaler test equipment, has launched its new 3rd generation Critical Flow Controller... Full article

Copley Scientific Introduces New, Upgraded Breath Simulators for Inhaled Product Testing

Nottingham, UK: Copley Scientific, the world’s leading manufacturer of inhaler test equipment, launches new advanced breath simulators, the BRS 2100 and BRS 3100, for orally inhaled product (OIP) development and testing... Full article

Copley Scientific Showcases New TPK™ 2100 Critical Flow Controller for Dry Powder Inhaler Testing at DDL2017

Nottingham, UK: Copley Scientific, the world’s leading manufacturer of inhaler test equipment, presented its new 3rd generation Critical Flow Controller—the TPK™ 2100—for the testing of dry powder inhalers (DPIs) at the 2017 Drug Delivery to the Lungs conference (DDL2017) in Edinburgh. Full article


November 2017 volume 24 issue 4

Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification

Intrinsic dissolution testing allows characterizing drug substances through its dissolution rate when exposed to a specified surface area in a specific dissolution media. This can be used to determine if a drug substance is highly or poorly soluble. Full article

Marcelo Dutra Duque1,2 Michele Georges Issa1 Daniela Amaral Silva1 Beatriz Ayumi Sakamoto Kakuda2 Leticia Norma Carpentieri Rodrigues2 Raimar Löbenberg3 Humberto Gomes Ferraz1
1Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo, Brazil
2Department of Exact and Earth Sciences, Institute of Environmental, Chemical and Pharmaceutical Sciences, Universidade Federal de São Paulo - UNIFESP, Brazil
3Faculty of Pharmacy & Pharmaceutical Science, Centre for Pharmacy & Health Research, University of Alberta, Canada
Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Intrinsic dissolution testing has been applied for characterization of pure API with respect to its dissolution behavior. The effect of formulation factors and processing parameters on dissolution rate is evaluated by dissolution testing of the final product, which is a time and resource-consuming process. Full article

Amjad Khan1 Zafar Iqbal2 Ismail Khan2 Abad Khan3 Lateef Ahmad3 Muhammad Akhlaq Mughal4 Aman Ullah2 Maria Kakar1
1Department of Pharmacy, Abasyn University, Peshawar, Pakistan
2Department of Pharmacy, University of Peshawar, Peshawar, Pakistan
3Department of Pharmacy, University of Swabi, Swabi, Pakistan
4Department of Pharmacy, Abasyn University, Islamabad, Pakistan
Formulations, characterization, in vitro and ex vivo release of Ephedra extract from topical preparations using dialysis cellulose membrane and natural rabbit skin

Ephedra is herbal medicine used in the treatment of many diseases, especially asthma and urticaria. The aim of this study was to formulate topical formulations as a microemulsion, a gel and an ointment containing the Ephedra extracts of (E. Intermedia), collected from Balochistan, Pakistan... Full article

Rahman Gul1,2,3 Syed Umer Jan1,4 Mahmood Ahmad5 Syed Faridullah4 Muhammad Akhtar5
1Faculty of Pharmacy, University of Balochistan, Quetta, Pakistan
2Department of Health, Government of Balochistan, Pakistan
3Balochistan University of Information Technology, Engineering & Management Sciences (BUITEMS), Quetta, Pakistan
4College of Pharmacy, University of Texas at Austin, Austin, TX, USA
5Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Pakistan
From in vitro-in vivo relationship (IVIVR) towards in vitro-in vivo extrapolation (IVIVE): A case study of pulmonary delivery systems

Based on the results from the literature, a direct relationship between dissolution profiles and in vivo markers of low molecular weight heparin (LMWH) concentration was discovered by application of the RIVIVR tool. Full article

Paweł Konrad Tuszyński1 Sebastian Polak2,3 Renata Jachowicz1 Aleksander Mendyk1
1Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Kraków, Poland
2Faculty of Pharmacy, Jagiellonian University Medical College, Kraków, Poland
3Simcyp Ltd. (a Certara Company), Blades Enterprise Centre, John Street, Sheffield, South Yorkshire, UK
Dissolution testing of bilayer tablets: Method development, validation and application in post-marketing quality evaluation

Bilayer tablets are gaining importance as they provide a multilayer system for administration of incompatible or synergistic drugs and reduce the dosing unit burden. Furthermore, two different APIs or portions of an API with different release characteristics can be formulated as single unit, having different layers. Full article

Amjad Khan1 Zafar Iqbal2
1Department of Pharmacy, Abasyn University, Peshawar, Pakistan
2Department of Pharmacy, University of Peshawar, Peshawar, Pakistan
Workshop Report: Implementation of Biowaivers based on the Biopharmaceutics Classification System

The first Panamerican Workshop on “Implementation of Biowaivers based on the Biopharmaceutics Classification System” (BCS) was held April 26 and 27, 2017 at Pontificia Universidad Católica de Chile, in Santiago, Chile. There were 150 participants representing... Full article

Pablo González Cisterna1 Vinod Shah2 Peter Langguth3 James E. Polli4
1Departamento de Farmacia, Facultad de Química, Pontificia Universidad Católica de Chile, Santiago, Chile
2Consultant, North Potomac, MD, USA
3Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg University Mainz, Mainz, Germany
4Department of Pharmaceutical Science, University of Maryland, Baltimore, MD, USA
Summary Report: Nanomedicines: Technical and Regulatory Perspectives Co-sponsored by: USP, AAPS, and FIP

If you were one of the nearly 150 people that attended the Nanomedicines workshop in Rockville, Maryland, on March 20-22th, 2017, you were able to confirm that medicines containing nanomaterials continue to be an evolving space in academia, industry, and regulatory environments. Full article

Amy R. Barker Margareth Marques Johannes Krämer Vinod P. Shah Horst-Dieter Friedel
Oral Biopharmaceutics Tools: What is New and What is Coming? APV/FIP Joint-Workshop in Nuremberg

Dissolution testing is an important tool from early development to life cycle management of a drug product. With the aim to give an update on the application of dissolution testing in assessing critical formulation attributes with regard to bioavailability... Full article

Sandra Klein*1,2
1Ernst Moritz Arndt University Greifswald Department of Pharmacy
2Institute of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport Greifswald, Germany
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

New Product Enhancements from Agilent

There are several new product changes from Agilent. The 708-DS Dissolution Apparatus has a new evaporation cover. The Chinese Pharmacopeia (CP) specifies... Full article

Rolling into the Last Quarter of 2017 with an Exciting Launch

This year has been particularly exceptional for Logan Instruments. It has seen continued growth by adding new customers to its already expansive outreach across the country and globe. Full article

Eclipse 5300 Dissolution Sampler by Distek receives CE, ETL, and FCC Mark Approval

North Brunswick, NJ - Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry, is pleased to announce that the Eclipse 5300 Dissolution Sampler has now received CE, ETL, and FCC mark approvals. Full article

Pharma Test Announces New Line of Integrated Online Dissolution Systems

Hainburg, Germany—October 2017—Pharma Test Apparatebau AG, a leader in the field of high-value testing equipment for the pharmaceutical industry, announced its new line of automated online tablet dissolution systems today. Full article


August 2017 volume 24 issue 3

Special Edition of Review Articles

Dissolution of Gelatin Capsules: Evidence and Confirmation of Cross-Linking

Cross-linking is a common problem in the dissolution of gelatin capsules. Cross-linking is characterized by a bridge across the peptide backbone of the gelatin molecule which creates water insoluble membranes or pellicles during dissolution testing... Full article

Xujin Lu1 Pankaj Shah1
1Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ, USA
Characterization and Simulation of Hydrodynamics in the Paddle, Basket and Flow-Through Dissolution Testing Apparatuses - A Review

Fluid velocity local to the dissolving surface will affect the dissolution rate. It is difficult to anticipate what local fluid velocities are present within compendial dissolution apparatuses from set flow rates or stirring rates... Full article

Valerio Todaro1 Tim Persoons2 Geoffrey Grove3 Anne Marie Healy1 Deirdre M D'Arcy4
1Synthesis and Solid State Pharmaceutical Centre, School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland
2Department of Mechanical and Manufacturing Engineering, Trinity College Dublin, Dublin, Ireland
3Sotax Corporation
4School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland
Physicochemical Properties of Buffers Used in Simulated Biological Fluids with Potential Application for In Vitro Dissolution Testing: A Mini-review

This literature review focuses on the physicochemical properties of buffers used in biorelevant media for in vitro dissolution testing. Because biorelevant dissolution systems have been previously reviewed, this review is primarily related to the buffers used in biorelevant media and not the media, per se... Full article

John W. Mauger1
1Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah College of Pharmacy, Salt Lake City, UT
In Vitro Release Testing of Semi-Solid Dosage Forms

In vitro release testing (IVRT) is used to monitor the release and diffusion of drug products from semisolid dosage forms (1-11) and has long been considered a valuable tool in formulation development. IVRT has also been used to screen formulations to select promising candidates, (12-16) and, importantly... Full article

Isadore Kanfer1,2 Seeprarani Rath3 Potiwa Purazi3 Nyengeterai Amanda Mudyahoto3
1Faculty of Pharmacy, Division of Pharmaceutics, Rhodes University, Grahamstown, 6140, South Africa
2Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, M4V 3B9, Canada
3Biopharmaceutics Research Institute, Rhodes University, Grahamstown, 6140, South Africa
Meeting Report: Dissolution Testing: Current and Future Considerations

The Joint Pharmaceutical Analysis Group (JPAG) and OrBiTo consortium (Oral Biopharmaceutics Tools) ran a highly successful and well-attended symposium covering dissolution testing at the Royal Society of Chemistry, Burlington House, London, the United Kingdom on Thursday 9th February 2017. Full article

Mark Santillo1 Steve Young2 Karin Bracht3 David Elder4 Axel Zeitler5 James Butler6 Karl Box7 Edmund Kostewicz8 James Mann9
1Plymouth Hospital NHS Trust, Derriford Hospital, Plymouth, Devon, PL6 8DH, UK
2British Pharmacopoeia, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UK
3MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UK
4JPAG Chairman, Hertford, Hertfordshire, SG14 2DE, UK
5Cambridge University, Cambridgeshire, UK
6GlaxoSmithKline, Product Development & Supply, Park Road, Ware, Hertfordshire, SG12 0DE, UK
7Sirius Analytical, Forest Row Business Park, Station Road, Forest Row, East Sussex, RH18 5DW, UK
8Institute of Pharmaceutical Technology, Goethe University, Frankfurt/Main, Germany
9AstraZeneca, Pharmaceutical Technology & Development, Macclesfield, UK
Dissolution Highlights from the 2016 AAPS Annual Meeting in Denver
AAPS Focus Group

The American Association of Pharmaceutical Scientists (AAPS) held its Annual Meeting and Exposition at the Convention Center in Denver, Colorado, on November 13-17, 2016. Pre-conference workshops took place November 12-13, 2016. Full article

Nikoletta Fotaki1 Deblina Biswas2 Susan D'Souza3 Johannes Krämer4 Xujin Lu5 Limin Zhang5
1Department of Pharmacy and Pharmacology, University of Bath, UK
2Virginia Commonwealth University, USA
3Tesaro Inc., USA
4PHAST, Germany
5Drug Product Science and Technology, Bristol-Myers Squibb Company, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Register for Leading Ingredient & Solutions Tradeshow SupplySide West 2017

PHOENIX, Arizona — SupplySide West is Now Vegas-Legal - Nutrition industry’s leading ingredient show celebrates its 21st year with more exhibitors, more education and new features. Full article

Pion Inc.'s Addition of UK's Sirius Analytical Instruments Forms One of World's Most Comprehensive IVPD Companies

Will Expand on Pion's Global Leadership Position in Analytical Instrumentation and Build Opportunities in Large Molecule Space Full article

Dissolution of Micro- and Nano-spheres Utilizing Float-A-Lyzer™ Attachments with the 708-DS

Novel dosage forms like microspheres and nanoparticles present a challenge when developing a standard method for in-vitro release. Currently, there are no compendial methods for these dosage forms and information on such drug release methodology is limited. Full article

Summer Time is an Exciting Time at Logan Instruments

Logan has launched a new initiative to boost its scale and scope on the domestic marketplace. In May, they hired, Sean Hill, who comes to them with a diverse, successful professional history... Full article


May 2017 volume 24 issue 2

Dissolution Testing of Herbal Medicines: Challenges and Regulatory Standards in Europe, the United States, Canada, and Asia

Herbal medicines are the oldest method for treating diseases and at the same time still the most commonly used worldwide. Although people in developing countries depend on traditional herbal medicines... Full article

Lucia Disch1,2 Jürgen Drewe1 Gert Fricker2
1Max Zeller Söhne AG, Romanshorn, Switzerland
2Institute of Pharmaceutics and Biopharmacy, Ruprecht-Karls University, Heidelberg, Germany
Evaluation of the Rupture Test for Stability Studies of Soft-Shell Capsules

The United States Pharmacopoeia (USP) implemented a rupture test in General Chapter <2040> for the evaluation of soft-shell capsules. It was first published in USP 30-NF 25 in 2007. Nutraceutical manufacturers showed in the past... Full article

Ghada Bachour1 Nadia Araci Bou-Chacra1 Raimar Löbenberg1
1University of Alberta, Edmonton, Canada
Stability and In Vitro Dissolution Studies of Metronidazole Tablets and Infusions

The aim of this study was to compare metronidazole tablets (500 mg) and infusions (500 mg/100 mL) obtained from Saudi and Egyptian suppliers. Evaluation of the tablets included weight variation, hardness, friability, drug content, disintegration time, and dissolution profiles. Full article

Fadilah S. Aleanizy1 Huda Al-Eid2 Eram El Tahir1 Fulwah Alqahtani1 Omaimah Al-Gohary1
1College of Pharmacy, Department of Pharmaceutics, King Saud University, Riyadh, Saudi Arabia
2College of Pharmacy, Department of Pharmaceutics, Dammam University, Dammam, Saudi Arabia
Development and Validation of a Discriminatory Dissolution Testing Method for Orally Disintegrating Tablets (ODTs) of Domperidone

The orally disintegrating tablet (ODT) is a novel dosage form that disintegrates in the oral cavity using saliva as the disintegrating medium and is swallowed as a fine dispersion. Full article

Amjad Khan1
1Department of Pharmacy, Abasyn University, Peshawar-25120, Pakistan
In Vitro Dissolution Profiles of Two Diltiazem Tablet Formulations and a Compounded Capsule Formulation: A Comparative Study

The dissolution test is usually employed to evaluate the performance of drug products. In this study, we compared the in vitro dissolution profiles of two diltiazem hydrochloride tablet formulations with that of a diltiazem hydrochloride compounded capsule formulation. Full article

Mateus Araújo Castro e Souza1 Carlos Eduardo de Oliveira Pereira1 Fernando Henrique Andrade Nogueira2 Gerson Antônio Pianetti1
1Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos 6627, 31270-901, Belo Horizonte, MG, Brazil
22Departamento de Farmácia, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Rua General Gustavo Cordeiro de Faria, S/N, 59012-570, Natal, RN, Brazil
Technical Note: Solubility Measurements

The solubility of any active pharmaceutical ingredient (API) in aqueous solutions is key information that should be obtained as early as possible in the development of a new product. Full article

Margareth R. C. Marques1
1U. S. Pharmacopeia
Guest Editorial for DISSOLUTION TECHNOLOGIES

Along with my recent retirement, I have reviewed and reminisced about all that has happened in our industry these last fifty years... Full article

Royal Hanson1
1Teledyne Hanson Research Inc.
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Agilent Online UV Dissolution Software Updates

Agilent’s Cary 60 and Cary 8454 UV-vis spectrophotometers are ideal for online UV dissolution systems. Easily pair a 708-DS Dissolution Apparatus with either spectrophotometer for a single-source UV dissolution testing solution. Full article

Teledyne Hanson Research Releases Vision Protocol Manager

For dissolution labs running Vision equipment, Hanson’s new software manages all instruments, users, and protocols in a single desktop view. Full article

ERWEKA Introduces the New USP 4 DFZ ll

March 22, 2017—ERWEKA, the premium brand of test equipment for the pharmaceutical and life science industries, introduces the new USP 4 Flow-Through Cell DFZ ll. Full article

Distek, Inc., Releases Eclipse 5300 Automated Dissolution Sampler

North Brunswick, NJ—February 22, 2017—Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry as well as an experienced provider of validation and qualification services, announced today the release of the Eclipse 5300 automated dissolution sampler. Full article

Distek, Inc., Releases Model 2500 Select Bathless Dissolution Tester

North Brunswick, NJ—April 17, 2017—Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry as well as an experienced provider of validation and qualification services, announced today the release of the Model 2500 Select Bathless Dissolution Tester. Full article

Simulations Plus Releases GastroPlus™ Version 9.5

LANCASTER, CA—April 5, 2017—Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, today announced that it has released version 9.5 of its flagship PBPK modeling program, GastroPlus™. Full article

Simulations Plus Finalizes Distributor Agreement with Korean Company

LANCASTER, CA—April 6, 2017—Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, today announced that it has entered into a distributor agreement in South Korea with Quantum Bio Solutions (Q-Bio). Full article

NEW SUSPENSION DRUG TESTING SYSTEM FROM LOGAN INSTRUMENTS CORP.—MORE DETAILS REVEALED

Somerset, NJ—April 20, 2017—With a large array of products, Logan Instruments Corp. has further improved upon its latest suspension system with a switchable dry-heat compartment. Full article


February 2017 volume 24 issue 1

Special Edition on Veterinary Product Dissolution

Characterization of the In Vitro Drug Exchange Profile of a Modified-Release Parenteral Solution for Veterinary Use

The release or exchange profile of an active pharmaceutical ingredient (API) from its carrier or formulation matrix is an important characteristic of a drug product, especially for that of a long-acting or modified-release formulation. Full article

Timothy S. Priddy1,2 Ronald R. Roush1 Lawrence Bryson3 Martin Folger2
1Department of Vaccine Assay Development, Boehringer Ingelheim Vetmedica, Inc., MO, USA
2Global CMC Development Pharmaceuticals, Boehringer Ingelheim Vetmedica GmbH, Ingelheim am Rhein, Germany
3Department of Biometrics and Statistics, Boehringer Ingelheim Vetmedica, Inc.,MO, USA
A Practical Approach to Dissolution Testing of Type A Medicated Articles

The application of dissolution to medicated Type A articles that are combined with animal feed to treat veterinary medical needs is a relatively new application. These products present novel challenges for traditional dissolution methodologies. Full article

Danna Mattocks1 Kailas Thakker2
1TherapeuticsMD, 6800 Broken Sound Parkway NW, Boca Raton, FL
2Tergus Pharma, 2810 Meridian Parkway, Durham, NC
Solubility Criteria for Veterinary Drugs

This Stimuli article is the first step toward the development of a general chapter addressing solubility criteria for veterinary drug products. The current criteria for classifying drug solubility are based on human gastrointestinal (GI) physiology. Full article

Mike Apley1 Bryan Crist1 Mario A. Gonzalez1,2 Robert P. Hunter1 Marilyn N. Martinez1 Sanja Modric1 Mark G. Papich1,3 Alan F. Parr1,2 Jim E. Riviere1 Margareth R.C. Marques4
1USP Expert Panel, Solubility Criteria for Veterinary Products
2USP Expert Committee on Dosage Forms
3USP Expert Committee Small Molecules
4US Pharmacopeia
Determination of Thermodynamic Solubility of Active Pharmaceutical Ingredients for Veterinary Species: A New USP General Chapter

This Stimuli article discusses the approach for the development of a new general chapter on solubility determination for veterinary drug products. Possible procedures are discussed, with emphasis on the shake-flask method. Recommendations are included on the test conditions for products to treat dogs and cattle. Full article

Mike Apley1 G. Bryan Crist1 Vivek Fellner2 Mario A. Gonzalez1,3 Robert P. Hunter1 Marilyn N. Martinez1 Janis R. Messenheimer1 Sanja Modric1 Mark G. Papich1 Alan F. Parr1,3 Jim E. Riviere1 Margareth R. C. Marques4
1USP Solubility Criteria for Veterinary Products Expert Panel
2Dept. of Animal Science, North Carolina State University
3USP Dosage Forms Expert Committee
4Principal Scientific Liaison, USP
Technical Note: Analysis of Compounded Animal Drug Samples

Samples of an animal health solid oral dosage form were obtained from four compounding pharmacies in the United States. Standard quality and performance tests were conducted on the samples including dissolution testing. Results are presented, and the value of dissolution testing as part of a quality assessment is discussed. Full article

Kent Alleman1
1Zoetis, Analytical Sciences, Kalamazoo, MI
BOOK REVIEW Poorly Soluble Drugs: Dissolution and Drug Release

This book will be a valuable training or reference addition for everyone involved with development or application of dissolution tests for poorly soluble drugs. Full article

Gregory Martin1
1Complectors Consulting, Pottstown, PA
Meeting Report: USP Workshop on In Vitro Testing for Meeting Future Challenges for Veterinary Dosage Forms

The United States Pharmacopeial Convention hosted the USP Workshop on In Vitro Testing for Meeting Future Challenges for Veterinary Dosage Forms at its headquarters in Rockville, MD, USA, on March 14 and 15, 2016. Full article

Margareth R. C. Marques1
1U.S. Pharmacopeia, Rockville, MD, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Alliance Calibrations Group and Logan Instruments Form Partnership

Alliance Calibrations Group (ACG), a multi-OEM equipment service company for analytical laboratories, and Logan Instruments, one of the world’s leading experts in dissolution, are announcing a partnership for the maintenance, calibration, validation, repair, and distribution of Logan’s product lines in the northeastern United States. Full article

Agilent Dissolution Vessels—the TruAlign Difference

As the dissolution industry continues to trend toward mechanical qualification (MQ) and away from the USP Performance Verification Test (PVT), vessel quality is under more scrutiny than ever before. With no standardized chemical testing, how are vessel irregularities—most of which are invisible to the naked eye—detected? Full article

Agilent 280-DS MQS Capabilities Extended

The measurement device that has taken the dissolution industry by storm now has even more capabilities. The 280-DS Mechanical Qualification System (MQS) provides laboratories with a solution to rethink how qualification of USP Apparatus 1 and 2 is managed. Full article

Hanson Research Acquired by Teledyne Instruments

The acquisition of Hanson Research by Teledyne Instruments signals a new era of expanded growth and accelerated innovation in dissolution and diffusion-testing segments. Full article

ERWEKA Has Launched the DVC-24—Dissolution Vessel Cleaning Faster Than Ever Before

ERWEKA, the premium brand of test equipment for the pharmaceutical and life science industries, has launched the new Dissolution Vessel Cleaner DVC-24. Full article


November 2016 volume 23 issue 4

Development of a Discriminating Dissolution Method for Immediate-Release Soft Gelatin Capsules Containing a BCS Class II Compound

The purpose of this study was to develop a robust dissolution procedure for liquid-filled, soft gelatin capsules (SGCs) that can distinguish small but real changes in drug product formulation. Full article

Festo Damian1 Mohammad Harati2 Vinayak Pathak2 Jeff Schwartzenhauer2 Doug Durham2 Vince Quiquero2 Owen Van Cauwenberghe1,2 Shawn D. Wettig1,3
1School of Pharmacy, University of Waterloo, 200 University Ave. W, Waterloo, ON N2L 3G1, Canada
2Accucaps Industries Ltd., 2125 Ambassador Dr., Windsor, ON N9C 3R5, Canada
3Waterloo Institute for Nanotechnology, University of Waterloo, 200 University Ave. W, Waterloo, ON N2L 3G1, Canada
In Vitro Simulation of Human Digestion: Chemical and Mechanical Behavior

The drug release pattern from an orally administrated pharmaceutical dosage form can be significantly affected by simultaneous food intake and drug administration due to the changes in the gastrointestinal physiology, in particular because of the pH profile evolution and of the mixing conditions. Full article

Sara Cascone1 Annalisa Dalmoro2 Gaetano Lamberti1 Giuseppe Titomanlio1 Matteo d'Amore2 Anna Angela Barba2
1Department of Industrial Engineering, Via Giovanni Paolo II 132, University of Salerno, 84084 Fisciano (SA), Italy
2Department of Pharmacy, Via Giovanni Paolo II 132, University of Salerno, 84084 Fisciano (SA), Italy
Applicability of Bottom-View Cameras for Evaluation of Tablet Performance During Dissolution Testing

Visualization techniques are frequently used to provide additional information on dissolution processes. The camera system used here, placed underneath the dissolution bath, enabled a bottom view into each separate vessel with the possibility for continuous video recording throughout dissolution testing. Full article

Tjaša Felicijan1 Ana Krese1 Aleš Mrhar1 Marija Bogataj1
1Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, Ljubljana, SI-1000 Ljubljana, Slovenia
Optimization of a Dissolution Method in Early Development Based on IVIVC Using Small Animals: Application to a BCS Class II Drug

The aim of the present study was to develop optimal dissolution conditions for a BCS Class II drug in early development. The model drug efavirenz was formulated in two dosage forms: a classical immediate-release suspension and modified-release cubosomes. Full article

Supriya Deshmukh1 Amelia Avachat1 Atul Garkal1 Naveen Khurana2 Jean-Michel Cardot3
1STES’s Sinhgad College of Pharmacy, Vadgaon (BK), Pune 411041, India
2Lupin Research Park, Pune, India
3University of Auvergne, 28 Place H. Dunant, BP 38, 63001 Clemont-Ferrand, France
Book Review: Desk Book of Pharmaceutical Dissolution Science and Applications

As the editors indicate in the forward, this book is intended to address the state of dissolution testing beyond tablets and capsules dosage forms. The book, supported by the Society for Pharmaceutical Dissolution Science (SPDS), covers the current status of dissolution science related to such timely topics as bioavailability, mathematical treatment of data, novel dosage forms, international guidelines and harmonization, automation, and other important dissolution topics. Full article

Vivian A. Gray1
1Dissolution Technologies Hockessin, DE 19707
AAPS Focus Group
Meeting Report: AAPS-NIFDC Joint Workshop on Dissolution Testing, Biowaiver, and Bioequivalence

A joint workshop of the American Association of Pharmaceutical Scientists (AAPS) and the Chinese National Institutes for Food and Drug Control (NIFDC) on dissolution testing, biowaiver, and bioequivalence took place in Tianjin, China, from June 21 to 22, 2016. Full article

Xujin Lu1 Vivian A. Gray2 Nikoletta Fotaki3 Jian-Hwa Han4 Johannes Krämer5 Erika Stippler6
1Bristol-Myers Squibb Company, New Brunswick, NJ, USA
2V. A. Gray Consulting, Hockessin, DE, USA
3University of Bath, Bath, UK
4Abbvie, Inc., North Chicago, IL, USA
5PHAST GmbH, Homburg, Germany
6U.S. Pharmacopeia, Rockville, MD, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Agilent Dissolution Systems Digital Source Book Now Available

The Dissolution Systems Source Book has been released in three different formats: printed catalog, PDF, and now an interactive version we are excited to call our Digital Source Book. Full article

Simulations Plus Releases PKPlus™ Version 1.0 Next-Generation Software for Preclinical and Clinical Trial Data Analysis

Simulations Plus, Inc. (NASDAQ: SLP), the premier provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, today announced that it has released version 1.0 of PKPlus, its next-generation software for analysis of preclinical and clinical trial data. Full article

Hanson Research Releases New Phase One™ Disintegration Tester

Hanson Research, well known for its broad line of dissolution-testing and diffusion-testing instruments, announced today it has extended its offerings to include disintegration testing. Full article

Distek, Inc. Releases Opt-Diss 410 In Situ UV Fiber Optic System for Dissolution Testing

Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry as well as an experienced provider of validation and qualification services, announced today the release of the Opt-Diss 410 next generation in situ UV fiber optic system for dissolution testing. Full article

Waters and SOTAX Group Sign Co-Marketing and Re-Seller Agreement

Waters Corporation (NYSE:WAT) announced today that it has entered into an exclusive agreement with the SOTAX Group, a global developer and manufacturer of equipment for dissolution testing, automated sample preparation, and physical testing of pharmaceutical dosage forms. Full article

Dissolution Accessories Appoints Vortex as Its U.S. Distributor

Dissolution Accessories and Vortex Sales Group LLC today jointly announced an agreement making Vortex the U.S. distributor for the Dissolution Accessories product line. Full article


August 2016 volume 23 issue 3

A Brief Review of the FDA Dissolution Methods Database

The FDA Dissolution Database was reviewed using the following criteria: dosage forms, apparatus, rotation/pulsation speed, dissolution media, sampling time points, and trends for special dosage forms. In July 2015, there were 1084 drug products in the database, more than 50% thereof in tablet form. Full article

I. E. Shohin1 D. Yu. Grebenkin2 E. A. Malashenko3 Ya. M. Stanishevskii2 G. V. Ramenskaya3
1Center of Pharmaceutical Analytics Ltd, Moscow, Russia
2Institute of Biochemical Technology and Nanotechnology Peoples’ Friendship University of Russia, Moscow, Russia
3I. M. Sechenov First Moscow State Medical University, Moscow, Russia
Influence of Test Parameters on Release Rate of Hydrocortisone from Cream: Study Using Vertical Diffusion Cell

Vertical diffusion cells (VDC) have been envisaged as in vitro surrogates for ensuring product quality and performance for topical preparations. Full article

Preethi Naik1 Sanket M. Shah1 John Heaney2 Royal Hanson2 Mangal S. Nagarsenker1
1Department of Pharmaceutics, Bombay College of Pharmacy, Mumbai, India
2Hanson Research Corporation, Chatsworth, CA
Development and Assessment of a USP Apparatus 3 Dissolution Test Method for Sustained-Release Nevirapine Matrix Tablets

Dissolution testing is a quality control tool used to assess batch-to-batch performance of dosage forms, thereby providing continued assurance of product quality. Analytical methods for the assessment of pharmaceutical product quality must be validated according to regulatory guidelines to ensure that tests are reliable and valid. Full article

Chiluba Mwila1 Sandile M. M. Khamanga1 Roderick B. Walker1
1Division of Pharmaceutics, Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa
In Vitro Dissolution Similarity as a Surrogate for In Vivo Bioavailability and Therapeutic Equivalence

Generic immediate-release solid oral dosage forms containing BCS Class I and III drugs that have similar in vitro dissolution profiles might receive market authorization without in vivo bioequivalence testing. Full article

Sally A. Helmy1,2 Heba M. El Bedaiwy1
1Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
2Department of Clinical and Hospital Pharmacy, Faculty of Pharmacy, Taibah University, AL-Madinah AL-Munawarah, Kingdom of Saudi Arabia
Comparative In Vitro Dissolution Testing of Hydrophilic Controlled-Release Venlafaxine Matrix Tablets and Effexor XR Using QbD

A hydrophilic matrix-based, controlled-release formulation for venlafaxine HCl (Ven HCl) was developed using a combination of various forms of hydroxypropyl methylcellulose (HPMC K4M, K15M, and K100M). Full article

Shashikant Barhate1 Maria Husain2
1Department of Pharmaceutics, Shri Suresh Dada Jain Institute of Pharmaceutical Education and Research, Maharashtra, India
2Department of Pharmaceutics, Y.B. Chavan College of Pharmacy, Maharashtra, India
Dissolution Technologies: Update on New Features and Activities

In the August 2014 issue of Dissolution Technologies (1), which celebrated our twenty-year anniversary, was an article that commented on past achievements and gave some indication of future activies. In this article, we will update you on new features that will be of interest to the readers, authors, and advertisers. Full article

Vivian A. Gray1
1Dissolution Technologies, Hockessin, DE, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

850-DS 8-Channel Filter Plates

AGE Whatman has increased its offering of 8-channel filter plates for use in the Agilent 850-DS autosampler and now offers a variety of filter plates with a pore size of 0.2 µm. Full article

Logan Instruments Corp. Introduces New Dry Heat Automated Topical and Transdermal System

The System 914 combines the features of the DHC-6T, a waterless system, with a new automated sampling system where the syringe pump takes samples from the cells to a sample collector using program parameters selected with the sampling controller. Full article

Pion Inc. Is on the Verge of Releasing Brand New FLUX Technology

The need to test finished drug products for their absorption potential in order to predict pharmacokinetic performance has been a topic of great interest to the drug development community. Full article

Simulations Plus Releases DDDPlus Version 5.0

Simulations Plus, Inc. (NASDAQ: SLP), the premier provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, today announced that it has released Version 5.0 of its DDDPlus™ in vitro dissolution experiment simulation software. Full article

Hanson Research to Host USP Dissolution Courses October/November 2016

Hanson Research Corporation has been selected to host USP courses on Dissolution Theory and Best Practices, and Validation of Dissolution Procedures at Hanson’s headquarters in Chatsworth, California during the last week of October and first week of November, 2016. Full article

Distek, Inc., Awarded U.S. Patent for Multi-Motion Assembly Design

Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry as well as an experienced provider of validation and qualification services, has been awarded U.S. Patent 9,333,469 for its multi-motion assembly design. Full article

Distek, Inc. Releases BIOne Single-Use Bioreactor System

Distek, Inc., has developed a benchtop-scale, single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production. Full article

Copley Scientific Celebrates Seven Decades of Responsive Service to the Pharmaceutical Industry

Copley Scientific, a family-owned company that began supplying glassware to the UK pharmaceutical industry in 1946, is celebrating the seven decades of success that have led to its current position as the global leader in inhaled product testing equipment. Full article

ERWEKA Presented Three New Products at Analytica in Munich

ERWEKA, the premium brand for test equipment for the pharmaceutical and life science industries, presented three new products at this year’s Analytica in Munich. Full article

SOTAX Releases C+, Centrifuge Additon for Fully Automated Sample Preparation Clarification

SOTAX has launched the C+, an automated centrifuge module for clarification of samples during fully automated sample preparations. Full article

Dissolution Accessories Introduces Certified Automation Syringe Filter, Suited for All Automation Machines

Dissolution Accessories introduces a cost-effective automation syringe filter. The Dissolution Accessories syringe filter has exact dimensions to ensure proper alignment and a smooth filter-to-filter release. Full article

Nanomedicines: Technical and Regulatory Perspectives Workshop

March 20-22, 2017 | USP Meetings Center | Rockville, Maryland, USA Full article


May 2016 volume 23 issue 2

Monitoring Drug Release from Electrospun Fibers Using an In Situ Fiber-Optic System

Electrospun fiber mats are currently gaining attention as advanced drug delivery systems. Dissolution testing for such systems is generally performed in small vials by immersing the fiber mats in buffered solutions. Full article

Salem Seif1,2 Florian Graef3 Sarah Gordon3 Maike Windbergs1,2,3
1Saarland University, Department of Biopharmaceutics and Pharmaceutical Technology, Saarbruecken, Germany
2PharmBioTec GmbH, Saarbruecken, Germany
3Helmholtz Centre for Infection Research (HZI) and Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Department of Drug Delivery (DDEL), Saarbruecken, Germany
Development and Validation of a Discriminating Dissolution Method for Atorvastatin Delayed-Release Nanoparticles Using a Flow-Through Cell: A Comparative Study Using USP Apparatus 4 and 1

Atorvastatin, an HMG CoA reductase inhibitor, is widely used for the treatment of dyslipidemia and prevention of cardiovascular disease. It belongs to Class 2 of the Biopharmaceutics Classification System owing to its low solubility and high permeability. Full article

Sandip Gite1 Manasi Chogal1 Vandana Patravale1
1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N. P. Marg, Matunga, Mumbai, India
Assessment of the Pharmacopeial Analytical Methodologies in the Dissolution Test of Enteric-Coated Lansoprazole Preparations

The performance of the analytical methodologies recommended by the United States Pharmacopoeia (USP) monograph(1) for dissolution testing of lansoprazole (LPZ) enteric-coated solid dosage forms (capsules/tablets) was critically evaluated. Full article

Alaa M. Abu Hammad1 Imad I. Hamdan1 Dina El-Sabawi1
1Faculty of Pharmacy, The University of Jordan, Amman, Jordan
Discriminatory Dissolution Method Development and Validation of Etoricoxib Tablets

The availability of a discriminatory dissolution method for use in either quality control testing or product evaluation in quality by design trials is mandatory for products intended for the developed market. Full article

Yasvanth Ashokraj1 Atul Daroi1 Raja Gupta1 Aruna Khanolkar1 Amol Kulkarni1 Swati Laud1 Milind Pokale1 Sanjeet Shedge1 Praveen Date1
1CIPLA Ltd, Mumbai, India
Evaluation of Pharmaceutical Quality of Conventional Dosage Forms Containing Paracetamol and Caffeine Available in Turkish Drug Market

The aim of this study was to evaluate the quality of conventional paracetamol- (PA) and caffeine- (CA) containing combined dosage forms in the Turkish drug market. Full article

Emrah Akgeyik1 Mustafa Sinan Kaynak1 Mustafa Çelebier2 Sacide Altinöz2 Selma Şahin3
1İnönü University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Malatya, Turkey
2Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, Ankara, Turkey
3Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Turkey
Dissolution Highlights from the 2015 AAPS Annual Meeting in Orlando

The meeting is a premier gathering of pharmaceutical scientists from around the world and works to address the needs of the attendees, including members of over 40 focus groups in nine sections, or scientific disciplines, including two focused on dissolution testing: the In Vitro Release and Dissolution Testing and QbD and Product Performance groups. Full article

Nikoletta Fotaki1 Vivian Gray2 Johannes Krämer3 Dorys Diaz4 Talia Flanagan5 Geoffrey Grove 66
1Department of Pharmacy and Pharmacology, University of Bath, Bath, UK
2Dissolution Technologies, Hockessin, DE, USA
3PHAST, Homberg, Germany
4Pfizer, Groton, CT, USA
5Astra Zeneca, Macclesfield, UK
6Sotax, Westborough, MA, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Logan Instruments Corp. Merges Its Latest Suspension System with USP 4 Testing Methods

April 6, 2016—With the success of the SUS-4000 Suspension System, Logan Instruments Corp. has advanced its design to accommodate USP 4 testing methods within the same system. In operation, the dry heat module stays in the horizontal position for suspension-cell tests. For USP 4 application, the dry heat module is moved to the vertical position, where end users can insert flow-through cells. Full article

Redefining Dissolution Qualification

Originally webcast on January 26th, 2016, to a wide audience, this webinar provides an in-depth examination of the USP Performance Verification Test and the ramifications of moving to the enhanced Mechanical Qualification (eMQ) alternative. Viewers will gain insight to the historical background and current practices regarding qualification of USP Dissolution Apparatus 1 and 2 as well as an improved model moving forward. Full article

Pion Inc. Acquires the Service Business of Vortex Sales Group

Billerica, MA, USA—April 6, 2016—Pion Inc. announced today the acquisition of the services division of Vortex Sales Group on February 2, 2016. Financial terms of the deal have not been disclosed. With the acquisition of these service contracts and service and support team members, Pion Inc. is broadening its offerings into the pharmaceutical laboratory with new instrumentation services geared toward the Analytical R&D and Quality Control laboratories. Full article

Desk Book of Pharmaceutical Dissolution Science and Applications

Question: What can you expect when expert scientists across the globe come together to publish a book on pharmaceutical dissolution science and applications? Answer: A masterpiece book—Desk Book of Pharmaceutical Dissolution Science and Applications. Full article

Hanson Research Launches New HRCare 360 Support Program

Los Angeles, CA—May 9, 2016—Hanson Research Corporation today announced the launch of HRCare 360 Support, a comprehensive program covering all dissolution and diffusion testing systems manufactured by Hanson Research. The release comes in the same year as Hanson's announcement of a three-year warranty for all instruments sold in 2016 in celebration of its 65th year in business. Full article

Distek, Inc., Celebrates 40 Years in Business

North Brunswick, NJ—March 22, 2016—Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories, and validation services, is proud to celebrate 40 years in business. Full article

Distek, Inc., Releases Next Generation Sample Probe & Filter for Manual and Semi-Automated Sampling

North Brunswick, NJ—February 23, 2016—Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories, and validation services, announced today the release of its next generation sample probe and filter as the preferred product for manual and semi-automated sampling. Full article


February 2016 volume 23 issue 1

Dissolution Model Development: Formulation Effects and Filter Complications

This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Full article

Ragna Berthelsen1 René Holm2 Jette Jacobsen1 Jakob Kristensen3 Bertil Abrahamsson4 Anette Müllertz11,5
1Department of Pharmacy, University of Copenhagen, Denmark
2Biologics and Pharmaceutical Sciences, H. Lundbeck A/S, Copenhagen, Denmark
3cJakob Pharma, Seattle, WA, USA
4AstraZeneca Pharmaceutics, R&D, Mölndal, Sweden
5Bioneer: FARMA, Department of Pharmacy, University of Copenhagen, Denmark
In Vitro Dissolution Curve Comparisons: A Critique of Current Practice

We review previously published work on dissolution profile similarity testing and provide a detailed critique of current methods in order to set the stage for a Bayesian approach. Full article

Dave LeBlond1 Stan Altan2 Steven Novick3 John Peterson4 Yan Shen2 Harry Yang5
1CMC Statistics Consultant, Wadsworth, IL 60083
2Janssen Research & Development LLC, Raritan, NJ 08869
3GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC 27709
4GlaxoSmithKline Pharmaceuticals, Collegeville, PA 19426
5MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
pH Dependence of the Dissolution Rate of EntericCoated Drug Spheres Determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Enteric coatings are widely used in formulations of drug delivery spheres. The coating protects an active pharmaceutical ingredient (API) from acidic conditions in the low pH environment of the stomach. Full article

Rachel Evans-Hurson1 Seán McSweeney1 Bastiaan Vos1 Jacob Krüse2 J. J. Keating1,3 Dara Fitzpatrick1
1Department of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland
2Kinetox, Beilen, The Netherlands
3School of Pharmacy, University College Cork, Ireland
Modulation of pH-Independent Release of a Class II Drug (Domperidone) from a Polymeric Matrix Using Acidic Excipients

Drug release from polymeric matrix systems is the rate-limiting step for drug bioavailability and is determined by drug solubility; most drugs show pH-dependent solubility. Full article

Amjad Khan1 Zafar Iqbal2 Abad Khan3 Muhammad Akhlaq Mughal2 Abbas Khan2 Zia Ullah2 Ismail Khan2
1Department of Pharmacy, Abasyn University, Peshawar-25120, Pakistan
2Department of Pharmacy, University of Peshawar, Peshawar-25120, Pakistan
3Department of Pharmacy, University of Swabi, Swabi, Pakistan
Influence of Various Media on the Dissolution Profiles of Immediate-Release Quetiapine Tablets in India

Dissolution testing was performed to evaluate the drug release from tablets. To mimic actual in vivo conditions, various foods and beverages were added to the dissolution media, and the release profiles were investigated. Indian people tend to have milk, curds, or eggs during their meals and then take their medications immediately after meals, whereas Americans tend to take medications with beverages. Full article

Zubin Shah1 Vaishali Londhe1
1Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, India
AAPS Focus Group
Meeting Report: AAPS In Vitro Release and Dissolution Testing Focus Group Face-to-Face Meeting

The AAPS In Vitro Release and Dissolution Testing (IVRDT) Focus Group had a Face-to-Face (F2F) Meeting on November 19, 2015, hosted by Bristol-Myers Squibb in New Brunswick, NJ. Xujin Lu (Bristol-Myers Squibb) was the Chair of the Organizing Committee, and the other members were Nikoletta Fotaki (University of Bath), Marie DiMaso (Corealis Pharma), and Vivian Gray (V. A. Gray Consulting). Full article

Vivian Gray1 Xujin Lu2 Jian-Hwa Han3 Dorys Diaz4 Geoffrey Grove5
1Dissolution Technologies, Hockessin, DE, USA
2Bristol-Myers Squibb, New Brunswick, NJ, USA
3AbbVie, North Chicago, IL, USA
4Pfizer, Groton, CT, USA
5Sotax, Westborough, MA, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA


Industry news

Upcoming Audit? Get Prepared with the New Dissolution Workstation

Software The new Agilent Dissolution Workstation software can help you meet your regulatory requirements. This paperless, compliant solution organizes all your dissolution methods and test data while controlling access and preventing unwarranted changes or errors. There’s no easier way to satisfy the necessary requirements for data storage and traceable records than this easy-to-implement software solution. Full article

Expanding In Product Development for Logan Instruments Corp. with Balloon Catheter Instrumentation and More

Somerset, NJ—January 17, 2016—Logan Instruments Corp. has diversified its portfolio through the expanding use of their Disso III-7 instrument. This year Logan Instruments Corp. has worked with customers on the development of instrumentation for the characterization and testing of combination products. With vast engineering knowledge, Logan Instruments Corp. has provided customers with Disso III-7 equipment for the evaluation of balloon catheters without the large cost of reinventing a brand new system. Full article

Pharma Test Announces Acquisition of J&M

Hainburg, Germany—January 2016—Pharma Test Apparatebau AG, a leader in the field of high-quality testing equipment for the pharmaceutical industry, announced today that it has acquired J&M Analytik AG, a German manufacturer and developer of fiberoptic diode-array spectrometer systems for laboratory and process applications. Full article

Hanson Research Announces Three-Year Warranty for Release-Rate Testing Instruments

Los Angeles, CA—February 1, 2016—Hanson Research announced today that it has increased the warranty period on its dissolution testing and diffusion testing instruments from one year to three years at no additional cost for all purchases invoiced and shipped during 2016. The 65th Anniversary Warranty program triples the industry average of one year, and in conjunction with Hanson Research’s global network of service and support professionals, it provides increased peace of mind and greater security for investments in laboratory equipment. Full article

USP Releases Online Database of Dissolution Methods

Rockville, MD-December 16, 2015—The USP Dissolution Methods Database is now available online. The database contains the test conditions (except Tolerances or Acceptance Criteria) as stated in the sections of the United States Pharmacopeia—National Formulary (USP-NF) referring to dissolution, disintegration, or drug release tests in the respective USP drug product monograph. Full article

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