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 Yahya 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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