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This is the last in a series of Stimuli articles developed by the USP Expert Panel New Advancements in Product Performance Testing charged with reviewing and proposing new approaches for drug performance testing in the US Pharmacopeia. The USP Expert Panel created working groups that focused on... Full article
Magnesium stearate is the most commonly used lubricant in the formulation and manufacture of oral solid dosage forms (compressed tablets and powder-filled capsules). However, its chemical and physical properties can adversely impact the final dosage form by... Full article
The potential advantages of larger sample sizes for dissolution testing through surrogate modeling in the context of continuous manufacturing and process analytical technology is the motivation for development of a statistically based batch release acceptance criterion. A common approach... Full article
Introduction: Dissolution plays a vital role as an in vitro test in the pharmaceutical product life cycle. For the evaluation of an appropriate dissolution test, analytical quality by design (AQbD) principles can provide increased confidence when deciding whether... Full article
Metformin, a class III drug in the Biopharmaceutics Classification System, is an orally administered drug used to lower blood glucose concentrations in patients with non-insulin-dependent diabetes mellitus. Critical quality attributes were evaluated and compared for... Full article
Introduction: The objective was to conduct a comparative dissolution study of several brands of enzalutamide capsules available in the Indian market using a model-independent approach. Enzalutamide is classified as a Biopharmaceutical Classification System class 2 medicine due to its limited... Full article
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.1The IDIS Tablet Dissolution software provides an open architecture allowing users to control a wide range of dissolution testers, spectrophotometers with unique HPLC automation. New features in newly released V4 provide greater compliance in automation. Full article
Redesigned platform offers ease-of-use, enhanced software engineering, and significant productivity gains for users Full article
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, has announced the acquisition of Pro-ficiency Holdings, Inc. and... Full article
According to the SDi Global Assessment Report 2022, Logan Instruments ranked third in the dissolution testing global market. Logan Instruments specializes in pharmaceutical testing equipment, offering a wide range of products including... Full article
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Commercially available dissolution vessels used with United States Pharmacopeia (USP) apparatus 1 and 2 typically have nominal inner diameters of 100 or 104 mm. Little data are available in the literature to evaluate whether equivalent dissolution results are obtained when the same product is tested in both types of vessels. This study provides... Full article
The flow-through cell is the preferred apparatus for dissolution testing of controlled-release dosage forms, poorly soluble drugs, and many special dosage forms, such as suspensions, soft capsules, implants, microspheres, and liposomes. Although the flow-through cell apparatus has been... Full article
Dissolution of oral solid dosage forms refers to the process by which active pharmaceutical ingredient(s) are released from the dosage form into a liquid vehicle, called the dissolution medium. Dissolution is an essential test for the development and quality control of almost all dosage forms. The availability of.. Full article
Type 2 diabetes is a chronic, multifactorial disease with a genetic predisposition caused by a deficit in the action or secretion of insulin, resulting in hyperglycemia, which is characterized by increased blood glucose levels. Metformin hydrochloride is the most frequently used medication. There is a wide.. Full article
Substandard medications have a negative impact on treatment outcomes. To get the desired therapeutic effect, drugs need to have the required pharmaceutical properties and the right amount of the active pharmaceutical ingredient. Thus, this study aimed to.. Full article
The American Association of Pharmaceutical Scientists (AAPS) successfully held its PharmSci 360 Annual Meeting and Exposition event on October 22-25, 2023, at the Orange County Convention Center in Orlando, FL. This year’s meeting was held entirely inperson and did not include a hybrid element, allowing... Full article
On April 6, 2023, the United States Pharmacopeia (USP) presented a webinar entitled “New USP Dissolution Performance Verification Standard: What, Where, and When.” The webinar was sponsored by the American Association of Pharmaceutical Scientists (AAPS) and AAPS In Vitro Release and Dissolution Testing (IVRDT) Community and... Full article
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.1Logan Instruments has developed the “EPVT-1200 system” for USP apparatus 1 and 2 Performance Validation Tests, aimed at revolutionizing the validation process of dissolution testers... Full article
Research project with NIEHS includes focus on qualification of in silico methods for prioritization, assessment of risk, and identification of safety margins for chemical use Full article
Partnership will produce an enhanced, validated dermal PBBM/PBPK model to inform product development and bioequivalence decisions Full article
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Quality and performance testing of topical and transdermal products encompasses a broad set of product types, test equipment, and unique considerations. This Stimuli article is one in a series of such articles on product testing methods that explore the relevant considerations and identify opportunities for standardization with different types of... Full article
Acetaminophen (paracetamol) is an analgesic and antipyretic drug that is widely used across the globe due to its efficacy and safety within the therapeutic dose range. When acetaminophen is ingested in amounts higher than the recommended dosage over several days, severe hepatotoxic effects can result. Next to the opioid drugs... Full article
Controlled-release capsules (named brand I and II) containing caffeine, available on the Brazilian and US market as dietary supplements, were assessed following the criteria described by the United States Pharmacopeia. The capsules were evaluated by average weight, caffeine content, disintegration, and... Full article
The present study aimed to confirm the biorelevance of the pH-gradient biphasic dissolution model for three ketoconazole (KTZ) formulations with different excipients and establish an in vivo-in vitro correlation (IVIVC). Experiments were performed with a pH-gradient biphasic dissolution model for drug absorption, consisting of... Full article
This study aimed to evaluate the highly variable in vitro dissolution profiles of generics and innovator montelukast products in the Turkish drug market by comparing model-dependent and model-independent analysis methods. Seven generic montelukast sodium products were tested, labeled G1-G7, and... Full article
Regulatory requirements for drugs approval in several countries allow pharmaceutical companies to market drug products after providing evidence of compliance with pharmacopeial quality requirements and good manufacturing practices, a policy that reduces drug treatment cost and increases... Full article
The objective of this study was to determine the in vitro therapeutic equivalence of multisource amoxicillin/clavulanic acid (875 mg/125 mg) tablets to establish their interchangeability with the reference product. Six multisource products manufactured in Peru, Colombia, Argentina, Mexico, and India were... Full article
Atorvastatin calcium is a prescribed medication for hyperlipidemia that is widely used in Indonesia, both the innovator and its generic products. The performance of each product may vary, but generic products must meet quality standards of bioequivalence with the innovator. This study aimed to... Full article
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.1Logan Instruments Corp. is proud to announce the next evolution in dissolution apparatus 1, 2, 5, and 6 Full article
Partnership aims to integrate experimental data and PBPK modeling to identify key formulation factors to accelerate modified-release product development Full article
North Brunswick, NJ - Distek, Inc., a well-reputed leader in laboratory pharmaceutical instruments, is excited to announce the release of the latest software update for the Opt-Diss... Full article
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Performance testing of mucosal drug products presents the user with a multitude of challenges. Not only are there many different dosage forms to be distinguished, but also a wide variety of administration routes. The target action effect (local or systemic) is another factor to be considered. Thus, it quickly becomes apparent that there will... Full article
Budesonide is a corticosteroid regularly used in oral formulations to treat various inflammatory diseases in the gastrointestinal tract, such as Crohn’s disease and ulcerative colitis. Budesonide has also been formulated to be effective against immunoglobulin A (IgA)-related nephropathy. This study aimed to... Full article
This study aimed to examine the in vitro dissolution performance of verapamil-HCl reference tablets using USP apparatus 2 (paddle), apparatus 4 (flow-through cell), and media of physiological relevance, and to estimate plasma levels using a convolution approach. The study used apparatus 2 at... Full article
Most drugs used to treat vaginal disorders are administered orally or parenterally. Mifepristone (MFP) is a Biopharmaceutical Classification System class IV drug that is currently used to abort pregnancies under 70 days long. To improve bioavailability, a modified liquisolid compact (MLSC) formulation has been... Full article
Bilastine and montelukast are Biopharmaceutical Classification System (BCS) class II compounds with low bioavailability, especially when taken orally. It is challenging to develop a dissolution test. The purpose of this study is to select an in vitro dissolution test that would be useful for... Full article
Rosuvastatin (RST) calcium is used to treat hyperlipidemia, and several generic brands of RST calcium are available in Saudi Arabia along with the innovator. The current study aimed to compare two generic brands of RST with the innovator with respect to physicochemical parameters and... Full article
The virtual workshop, “Approaches, Regulatory Challenges, and Advances in Bioequivalence, Dissolution Testing, and Biowaiver,” was held February 22-24, 2023, via the Zoom online platform. The conference was co-organized by the University of the Philippines College of... Full article
The AAPS In-vitro Release and Dissolution Testing (IVRDT) Community met for their annual inperson meeting at 2022 PharmSci 360 conference in Boston. The meeting was attended by more than 50 active members of the community who participated in an engaged and lively meeting. At the beginning... Full article
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.1Nottingham, UK: Copley Scientific has launched a blog with the aim of building a trusted, educational resource for anyone involved with pharmaceutical testing. Via regular posts from company experts, the blog will cover... Full article
The Dry Heat Pro Series Dissolution Tester replaces the traditional water bath. Each vessel has three-zone, contemporary, dry heat elements. The unique design ensures there is... Full article
Awards Program Recognizes Research and Leadership in Pharmaceutical Science Full article
New functionality, models, and partner data power predictive accuracy from the industryleading machine learning platform Full article
Collaboration with regulatory, industry, and academic partners will support and accelerate the development and validation of workflows to conduct virtual bioequivalence studies Full article
Dr. Lukacova’s outstanding contributions to pharmaceutical research and innovation to be recognized with seven others at AAPS PharmSci 360 Full article
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Nanoparticles can be used in pharmaceuticals to provide a targeted and prolonged release of active pharmaceutical ingredient (API). Nanoparticles are growing in application in the field of oncology due to developments in the field, but still there are issues faced with studying the in vitro release of long-acting injectables... Full article
Milk or milk-containing beverages can be used as vehicles for drug product administration and as a component of human fed-state simulated gastric fluids. Unprocessed bovine milk is also the matrix within which drugs must be solubilized or released when formulations are administered into the bovine... Full article
The objective of this study was to investigate the implications of changing dissolution parameters, including pH ramp time, absence and presence of simulated intestinal fluid (SIF), and the addition of a partitioning phase, using an automated dissolution-testing platform. The molar absorption coefficients, pKa, and dissolution... Full article
Low calcium intake is common worldwide and may lead to osteoporosis. Therefore, calcium supplementation is a vital resource to prevent fractures in patients with osteoporosis. The present study aims to assess whether the dissolution profiles of calcium tablets available in the Brazilian pharmaceutical market are... Full article
In vitro dissolution testing is an important tool for any oral drug product. It is useful for product development and to ensure the in vivo performance of drug products throughout their commercial life without conducting clinical or bioequivalence studies after regulatory approval. It also plays a role in... Full article
The purpose of this study was to perform a comparative dissolution study of various brands of valsartan tablets marketed in Pakistan. This drug belongs to BCS class II, which has high permeability and low solubility. Four different brands of valsartan tablets (80 mg) were collected from the local market of... Full article
Atorvastatin, a hypolipidemic medication, is commonly used as oral anti-atherosclerotic and cardiovascular protectant, with multiple marketed tablet brands available. This study aimed to assess critical quality attributes, including in-vitro dissolution characteristics, for five atorvastatin calcium tablet brands... Full article
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.1Prioritising a stronger customer interface and enhanced application expertise as company grows at pace. Full article
Delivering enhanced, customer-centric service across the company’s complete portfolio. Full article
April 2023, Logan Instruments proudly launched the Transdermal Diffusion Flow-Through Cell System, which is available in 6, 8, 12, 16, and 24-cells configurations, offering scalability and flexibility to accommodate diverse research needs. Full article
Registration for Oct. 22-25 Conference Now Open Full article
Acquisition increases breadth and depth of QSP expertise and range of therapeutic applications Full article
Lancaster, CA -- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced the release of a new integrated pulmonary software and services package. This targeted package will... Full article
The Verder Group is proud to announce the successful acquisition of ERWEKA, a highly regarded German company renowned for its development and manufacturing of premium tablet testing equipment. Full article
The Eastern Analytical Symposium and Exposition (EAS) is held annually to showcase leading-edge research and development in analytical chemistry and its allied sciences through the presentation of lectures, workshops, and short courses. An Exposition featuring the latest innovations in laboratory instrumentation and supplies related to these sciences is held concurrently with the symposium. Full article
North Brunswick, NJ - Distek, Inc., a reputable leader in laboratory pharmaceutical instruments, is pleased to announce the award of U.S. Patent 11,454,570 for their G2 sampling probe designed for dissolution testing and related applications. Full article
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Sleep problems, in particular the difficulty in initiating and maintaining sleep are important comorbidities in children and adolescents with attention deficit hyperactivity disorder (ADHD), accompanied by a range of negative consequences for both patients and their caregivers. Melatonin, a naturally occurring hormone that is important... Full article
The aim of the present study was to propose a Q dissolution value as a quality control test for 400-mg ibuprofen soft gel capsules using the dissolution recommendations included in the FDA dissolution database. Two commercial batches of the reference product and two batches of three generic products... Full article
In the current work, a laser monitoring technique was used to study dissolution and solubility of celecoxib (CBX) in 2-propanol and propylene glycol mixtures at temperatures of 293.2-313.2 K. The solubility data were fitted to mathematical models, i.e., the van’t Hoff model, the mixture surface model, the Jouyban-Acree... Full article
Gliclazide (GLZ) is an ampholyte with pH-dependent solubility in the gastrointestinal pH range. Although the effects of different pH values on GLZ release have been thoroughly investigated in compendial dissolution media, the effects of gastrointestinal fluid components and pH are not well known. Multiple response... Full article
Generic formulations share the same active pharmaceutical ingredient (API), but differences in excipients can impact the quality and efficacy of formulations. In this study, four gastro-resistant pantoprazole tablet formulations were selected from the Serbian drug market to compare... Full article
Introduction: Ciprofloxacin is a fluoroquinolone class of antibiotics with broad-spectrum antibacterial activity. Biowaiver studies of generic ciprofloxacin products can be used to establish bioequivalence with the reference product. Methods: The experiments are carried out using the... Full article
The virtual workshop, “A Quest for Biowaiver, Including Next Generation Dissolution Characterization and Modelling,” was held on November 16-17th, 2022, via the MS Teams platform. The conference was co-sponsored by Jagiellonian University Medical College (JUMC) in Cracow, Poland and the American Association of... Full article
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.1The Logan PERMETRO™ system consists of a proprietary dynamic dissolution-permeation apparatus and novel artificial intestinal membrane. PERMETRO was developed to overcome the limitations and bottlenecks of traditional IVIVC permeation testing by improving prediction of particle engineering, reformulation effects, and bioavailability enhancement. Full article
Data sharing partnership will expand chemical coverage space and improve model performance in support of new approach methodologies to ensure product safety Full article
Drug discovery services partnership with Sino-American Cancer Foundation focuses on the development of actionable hits against the MTHFD2 target Full article
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As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug product manufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability in CM. As such, the CM Working Group of the New Advancements in Product Performance Testing (NAPPT)... Full article
The objective of the current study was to develop an optimized formulation for orally disintegrating tablets (ODTs) containing melatonin. Different particle sizes of mannitol (i.e., filler) were used to study the effects on dissolution and tablet properties using a quality by design (QbD) approach. The quality target... Full article
This study aims to optimize the concentrations of hydroxypropyl methyl cellulose (HPMC) K4M and Eudragit L100-55 (methacrylic acid) in formulation of extended-release tablets containing guanfacine hydrochloride by employing a 32-factorial design approach. Extended-release tablets of guanfacine hydrochloride reduce the need for... Full article
The purpose of this study was to evaluate critical quality attributes (CQAs) of dapsone gel compared to its marketed reference gel, in accordance with United States Pharmacopeia and draft guidance established by United States Food and Drug Administration, which are based on suggestions about quality and performance of the... Full article
The dissolution rate of a drug directly affects its absorption and utilization in vivo. The dissolution test is used to evaluate the quality of formulation and production process. Entecavir is approved by the United States FDA for the treatment of chronic hepatitis B. Entecavir monohydrate (ETV-H) is used in commercial ETV tablets... Full article
Amoxicillin is a penicillin antibiotic widely prescribed to treat many infections. Several brands of oral forms of amoxicillin are available on the local market. The aim of this study was to evaluate the physicochemical quality and in vitro bioequivalence of several brands of amoxicillin capsules (500 mg) marketed in...
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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.1Quality Lab Accessories (QLA) is proud to announce our QLA brand expansion into the Asian market with the introduction of QLA Korea. QLA Korea is headquartered in South Korea and operated by Gyujong Lee. Full article
03 January 2023; Nottingham, UK: Copley begins 2023 with news of two key appointments to the senior team: Jamie Clayton as Managing Director and Matthew Fenn as Head of Business Development. The appointments follow a period of sustained growth for Copley... Full article
Logan Instruments Corp. is pleased to introduce the newest automated AIR-1300 Delivery Dosage Uniformity (DDU) Inhaler testing system and semi-automated next generation impactor (NGI) and Andersen cascade impactor (ACI) systems. Full article
New Contract to Support Development and Regulatory Assessment of Inhaled Products Full article
LANCASTER, CA, November 15, 2022 — Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, through a joint proposal with... Full article
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Quality control dissolution testing represents a key product performance test for solid oral dosage forms and is the most likely QC test to result in laboratory investigations... Full article
Performance testing of parenteral products represents a broad arena of product types, test equipment, and analytical challenges. This Stimuli article is one in a series of Stimuli articles on product performance testing focused on common methodological approaches used and challenges encountered in the field of... Full article
This is a review of the current status of drug bioequivalence studies in Peru. A bibliographic search was conducted in PubMed (Medline database) for bioequivalence studies in Peru. Generic drugs constitute the basis of pharmacological requests in health care systems... Full article
Similarity studies are used with the intention to establish interchangeability of certain formulations in vitro, without the need to carry out in vivo studies. This interchangeability between formulations should be conserved during the product shelf life, as an integral part of the pharmaceutical stability...
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The objective of this study was to evaluate the physicochemical quality control parameters and pharmaceutical equivalence of amlodipine besylate generic tablets and capsules with the innovator brands (Norvasc and Amlor, respectively) available in Riyadh, Saudi Arabia. Five brands of amlodipine besylate tablets...
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Analytical Testing for the Pharmaceutical GMP Laboratory (Hunyh-Ba, K.; Holberg, W.; Lin, J.; Ng, L. L.; Gray, V. A.; Famili, P.; Cleary, S.; Wiley, 2022. ISBN 9781119120919) is an excellent and comprehensive book. It includes extensive, concrete instructions and examples of key documents. Full article
The AAPS In-Vitro Release and Dissolution Testing (IVRDT) Community and Stability Community jointly organized the virtual workshop “Dissolution Best Practice and International Harmonization,” held on August 16th, 2022. The workshop was designed to bring awareness to differences in dissolution testing and acceptance criteria between... Full article
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.1LANCASTER, CA, October 11, 2022 — Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of version 9.8.3 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling platform, GastroPlus®. Full article
Langen, October 11, 2022 — ERWEKA GmbH is proud to announce the release of the digital stand-alone Dissolution Offline System for DT 950/9510 Series and the next generation friability and abrasion tester TAR II. Full article
Logan Instruments is proud to announce its newest innovation is a 3-in-1 system: Automated Dissolution Solubility Permeation (ADSP) system, designed to improve efficiency and accelerate development for pharmaceutical R&D. The ADSP system seamlessly integrates... Full article
SANTA CLARA, Calif., October 12, 2022 — Agilent Technologies Inc. (NYSE: A) today announced the opening of the Dissolution Center of Excellence (CoE) facility in Craven Arms, United Kingdom. The newly modernized premises will... Full article
Nottingham, UK, September 14, 2022: EnviroMate™ is a benchtop environmental control chamber from Copley, the world’s leading manufacturer and supplier of inhaler testing equipment, designed specifically to improve... Full article
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The purpose of this paper is to provide an overview of the activities of the USP Expert Panel on New Advancements in Product Performance testing. Full article
Liqui-Pellet technology has recently been developed and has shown to be promising in achieving a rapid drug release rate with water insoluble drugs. At present, only naproxen and ketoprofen have been applied to an oral solid dosage form for immediate release. The present investigation aims to explore the... Full article
A novel approach to test the similarity of clopidogrel batches by comparing drug dissolution profiles, based on the combination of principal component analysis with hierarchical cluster analysis (PCA-HCA), is presented. Dissolution curves corresponding to five brands of... Full article
Acetylsalicylic acid is one of the most prescribed medications in the world. It is used for prevention of acute myocardial infarction, colorectal cancer, antipyretic, and as an analgesic. This study aimed to investigate the in vitro bioequivalence of three formulations of acetylsalicylic acid, simulating physiological conditions...
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Acetaminophen is a widely used oral analgesic and antipyretic medication; however, quality control parameters may differ across various brands. The aim of the present study was to evaluate and compare critical quality attributes, including in-vitro dissolution characteristics, of five acetaminophen tablet brands...
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To date, few examples of dissolution models for real-time release testing (RTRT) have been approved for commercial drug products or published in literature. Thus, a structured approach has not been established by which a novice to the field could design, develop, validate, and implement an RTRT dissolution model. Full article
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.1Martinsried/Munich, Germany - RIGGTEK is is proud to introduce the new Dissolution Tester “Dissilio”. Full article
Funded partnership with large pharmaceutical company will enhance mechanistic dissolution models for injectable formulations Full article
PERMETRO introduces a new way for drug development, such as IVIVC, BE, and the interferences of food or during drug absorption. The system collects samples incrementally and cumulatively at the same time. For the first time, the Logan Permetro system uses a... Full article
Dissolution testing constitutes one of the most widely used in vitro performance tests during drug development and routine quality control testing. It monitors the rate and extent of in vitro drug release (batch release test), and it is often used to... Full article
In the case of most phosphate-binding agents, in vitro phosphate-binding studies are essential for establishing bioequivalence between generic and reference drug formulations. Traditionally, an incubator shaker is used to conduct phosphate-binding studies, but this method is limited by manual sample collection... Full article
In addition to removing excess extracellular fluid and mobilizing immune cells throughout the body, lymphatic fluid provides a means for drug transport. Lymphatic drug delivery can impart higher efficacy and bioavailability, especially following oral administration. Currently, there is no standardized composition... Full article
Liqui-Pellet formulations have been introduced as a technology to improve the dissolution rate of poorly water-soluble drugs. This study aimed to incorporate sodium bicarbonate (NaHCO3) into the Liqui-Pellet formulation to explore the potential impact on the drug release rate. Naproxen Liqui-Pellet formulations containing... Full article
Rosuvastatin (RST), a BCS class II drug, is a poorly water-soluble antihyperlipidemic agent. The aim of the present work was to determine and compare the drug release kinetics from the RST calcium innovator (Crestor) and generic products (Ivarin and Resova) marketed in Saudi Arabia by employing various... Full article
Losartan potassium (LOK) is an antihypertensive agent from the group of selective angiotensin AT1 receptor antagonists, widely used in the form of tablets for oral administration. The available data for BCS classification are confusing, though class III or IV are most likely. The quality attributes of... Full article
The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting and exposition event, PharmSci 360, at the Pennsylvania Convention Center in Philadelphia, PA, October 17-20, 2021. This year the PharmSci 360 meeting was both in-person and virtual. The PharmSci 360 annual meeting... Full article
Logan Instruments Corp. is pleased to introduce the UDT-1500 Automated Dissolution Tester (pictured below), the newest apparatus for dissolution testing required by USP. This 15-vessel dissolution tester is designed for easy operation by running one or two methods on a single unit. Full article
Attendees from 57 countries spend 2 days focused on advancing model-informed drug development Full article
Collaborative research effort will further enhance the ACAT model to aid scientists in the detailed understanding of local drug disposition in the gastrointestinal tract Full article
Pion, Inc. ("Pion"), a leading provider of analytical instrumentation for formulation development and quality control in the life sciences industry, has developed a fiber optic method to accurately perform in vitro dissolution testing to gain rich insights into particle molecule behavior, which is not usually seen until in vivo. By gaining pharmacokinetic insights before the clinical trial stage... Full article
CompareNetworks, Inc. (comparenetworks.com), a leading provider of online B2B marketplaces for the scientific and healthcare industries, announced the asset acquisition of Tablets & Capsules (T&C) magazine, a former CSC Publishing publication. Full article
This stimuli article is the first in a series to be written by the USP Expert Panel on New Advancements in Product Performance Testing. Today, a wide variety of nanomaterial-based drug products enter the US market, creating the need for reliable standards and technologies to... Full article
Apixaban is an anticoagulant agent that inhibits factor Xa, commercially available as coated tablets at the dosages of 2.5 and 5.0 mg. There is no official monograph of the formulation in the current international pharmacopoeias. From research and development to finished product quality control... Full article
Excipients play a very important role in the release pattern of an active pharmaceutical ingredient from topical semisolid dosages forms, and their physical and chemical properties can influence the release. The aim of this paper was to provide a validated, sensitive, and reproducible method to assess the... Full article
The aim of this study was to formulate and evaluate bisoprolol hemifumarate emulgel using carbopol 934P with the enhancers, thymus oil and olive oil. Thymus oil and olive oil were used as permeation enhancers. The emulsion formulations were added to a base gel. The emulgel was characterized for... Full article
This study aimed to determine the therapeutic equivalence of four multi-source drugs containing moxifloxacin (400 mg tablets) in vitro studies to establish their interchangeability with the reference product. Four multi-source products were acquired in pharmaceutical establishments in metropolitan Lima, each from different manufacturing sites...Full article
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.1San Bruno, California — Clearview Pharma Solutions LLC (www.clearviewpharmallc.com), a pharma/biotech consulting company for drug development announces that is offering two types of retainer services: “Pay for Work” and “Access” Retainer... Full article
Logan Instruments is proud to announce its newest innovation is a 3-in-1 system: Automated Dissolution Solubility Permeation (ADSP). The ADSP system is designed to improve efficiency and accelerate development for pharmaceutical R&D. The ADSP system seamlessly integrates the automated dissolution system, automated solubility testing system, and permeation/absorption system (PERMETRO). It has online UV detection and data analytic capabilities... Full article
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical and biotechnology industries, today announced the formation of the University+ Program as part of its 25th anniversary celebration... Full article
The Next Innovation in Validation Technology has arrived! The BT1000 Dissolution Validation and Reporting Bluetooth System is a critical tool for any laboratory looking for an easy way to maintain compliance in the digital age. The full suite of specialized, easy-to-use tools and intuitive software platform delivers the speed and flexibility you need to perform quick, efficient, and accurate dissolution tester calibration routines... Full article
IDIS Networking Solution Maximizes Efficiencies January 13, 2022, UK - Automated Lab Systems announces IDIS Data Management Software advanced networking capabilities. Having seen how crucial digital connection is to the modern world today, Automated Lab Systems has adopted IDIS software with Domain Authentication to propel it into an industry leader position for tablet dissolution automation and networking. The company recognizes that... Full article
Langen, January 20th, 2022 — ERWEKA GmbH is proud to start the year 2022 with two amazing new products - ERWEKA’s first digital high-volume dissolution tester DT 9510, with its innovative AirLift system for easy raising and lowering of the dissolution head, and the new ZT 730 disintegration tester with AirBasket - ERWEKAs first cable-free disintegration basket with automatic determination of the disintegration time. Full article
Apex vessels (previously known as PEAK vessels) are an important element of the dissolution scientist’s toolbox and are frequently used in pharmaceutical drug product development settings. However... Full article
Three groups of pessaries with clindamycin phosphate as the active substance, and with different concentrations of polysorbate 80 as a surfactant incorporated in the glycerol-gelatin base, were prepared simultaneously. Potential differences... Full article
The aim of the present study was to experimentally compare the attributes, drawbacks, and limitations of the most commonly employed in vitro drug release test methods for nanoparticle systems and to explore the possibility of... Full article
Biowaivers based on the Biopharmaceutics Classification System (BCS) class can be used to establish therapeutic equivalence based on dissolution tests, which can be used as a surrogate to determine if... Full article
Dissolution studies have evolved from quality control testing to being an indicator of biopharmaceutical performance and an alternative to in vivo bioequivalence and interchangeability studies in clinical practice...Full article
Virtual Public Workshop Hosted by Center for Complex Generics (CRCG) and US DFA August 18—20, 2021 Full article
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.1For rapidly dissolving dosage forms of BCS Class III drugs (high solubility, low permeability), intestinal permeability is considered to be the major rate-controlling step in oral drug absorption. Absorption kinetics of BCS Class III drugs from the gastrointestinal (GI) tract is controlled by biopharmaceutic and physiologic properties of... Full article
Logan Instruments is proud to present the filter changer system. The filter changer consists of 20 trays stacked on top of each other, with six syringe filters per tray. This system has an automated... Full article
Langen, July 12th, 2021 - ERWEKA GmbH is proud to announce the release of the new ERWEKA DT 950 dissolution systems powered by our latest Disso.NET software version 4.6. The software controlled, semi-automatic dissolution systems are the perfect entry to dissolution automation... Full article
There has been a growing interest in the use of biorelevant dissolution media in drug formulations research and development. Biorelevant media mimic the physiological conditions of the human gastrointestinal tract, which allows for a more discriminating... Full article
Efavirenz (EFV) was approved by the United States Food and Drug Administration in 1998 with no polymorphic forms, but further research defined 23 different forms, including amorphous and solvated forms. This study aims to determine the ability of dissolved EFV polymorphs... Full article
The aim of this study was to develop a method for set up and optimization of a pH-gradient biphasic dissolution model by orthogonal test design in light of the correlation with published in vivo data of ketoconazole (KTZ). A pH-gradient biphasic dissolution test... Full article
Biorelevant media, such as fasted state simulated intestinal fluid (FaSSIF), are often used to forecast in vivo behavior of oral solid formulations in the gastrointestinal tract. This study uses conventional surfactants... Full article
The purpose of this study was to establish the preparation process of ZGDHu-1 nanoparticles and to study its physicochemical properties. The nanoparticles were prepared using a high-pressure homogenization method. Natural phospholipid and soybean oil were... Full article
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.1Logan Instruments is proud to present the C&D 360 patch coat and drying (C&D) system with a built-in dryer. The C&D 360 consists of a motorize dual-peak-blade, which controls the thickness of the coating and an online heater to dry the patches. It is designed for small scale production of transdermal patches in the lab. Full article
Germany, Hainburg, July 2021 - Pharma Test announces an improved PT-DDS4 Media Preparation and Degassing System with an optimized tank and pipe outlet with bigger wheels for better daily handling. Full article
Agilent’s Dissolution Workstation Software (DWS) version 1.7 is now available to further facilitate compliance in your laboratory. This release provides significant updates to all three versions of the DWS platform - the core software for traditional manual or semi-automated systems as well as the 280-DS Mechanical Qualification System (MQS) and 400- DS small volume USP apparatus 7. Full article
Langen, July 12th, 2021 - ERWEKA GmbH is proud to announce the release of the new ERWEKA DT 950 dissolution systems powered by our latest Disso.NET software version 4.6. The software controlled, semi-automatic dissolution systems are the perfect entry to dissolution automation - no matter what type of system you want to run, from offline, to online... Full article
July 15, 2021, North Brunswick, NJ - From the company that has brought you over 45 years of excellence in laboratory pharmaceutical instruments, Distek, Inc. is proud to introduce the BIOne Mixing System. Full article
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
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
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
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
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.
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.
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
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
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.101 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
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
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
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
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
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
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
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
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
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
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
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
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.1Copley 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
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 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
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
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
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
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
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
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
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.1Generic 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 Gray1October 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 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’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
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
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
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
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
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
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.1These guidelines are effective September 1, 2020. Please forward questions and comments to the Research Editor, Vivian Gray, vagray@rcn.com
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
20-year FDA Master Reviewer will advise the planning of drug development programs with sponsor companies Full article
A Dissolution and Permeation All-In-One System Full article
After months of research, LOGAN is proud to present the SYSTEM 4000, an automated USP apparatus 4 sampling system. Full article
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
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
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
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
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
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
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
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.1March 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
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 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
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
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
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
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
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
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
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.1Agilent 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
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
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
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
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1The updated catalog includes all the Agilent dissolution apparatus, sampling instrumentation, accessories, and online UV systems as well as qualification tools. Full article
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 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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Highest quality, state-of-the art production, modern open space offices and sustainable thinking. Full article
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
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
Japanese government organization to train reviewers to efficiently analyze PBPK model submissions. Full article
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
November 18-20, 2019 Crowne Plaza Princeton Conference Center, Plainsboro, NJ Full article
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1North 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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Pion 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
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
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, 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
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 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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Copley 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
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, 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, 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., 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., 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1For 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., 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, 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
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 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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Nottingham, 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
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
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
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
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’ 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
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1The 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
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
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
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
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1There are several new product changes from Agilent. The 708-DS Dissolution Apparatus has a new evaporation cover. The Chinese Pharmacopeia (CP) specifies... Full article
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1PHOENIX, 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
Will Expand on Pion's Global Leadership Position in Analytical Instrumentation and Build Opportunities in Large Molecule Space Full article
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
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
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
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
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
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
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
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
Along with my recent retirement, I have reviewed and reminisced about all that has happened in our industry these last fifty years... Full article
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Agilent’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
For dissolution labs running Vision equipment, Hanson’s new software manages all instruments, users, and protocols in a single desktop view. Full article
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
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
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
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
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Alliance 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
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
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
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, the premium brand of test equipment for the pharmaceutical and life science industries, has launched the new Dissolution Vessel Cleaner DVC-24. Full article
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1The 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, 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, 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., 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 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 and Vortex Sales Group LLC today jointly announced an agreement making Vortex the U.S. distributor for the Dissolution Accessories product line. Full article
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
Vertical diffusion cells (VDC) have been envisaged as in vitro surrogates for ensuring product quality and performance for topical preparations. Full article
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1AGE 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
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
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, 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 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., 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., has developed a benchtop-scale, single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production. Full article
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, 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 has launched the C+, an automated centrifuge module for clarification of samples during fully automated sample preparations. Full article
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
March 20-22, 2017 | USP Meetings Center | Rockville, Maryland, USA Full article
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1April 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
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
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
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
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
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
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
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
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
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
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
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
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
Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.
Margareth Marques1 William Brown1Software 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
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
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
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
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
