February 2017 volume 24 issue 1

Special Edition on Veterinary Product Dissolution

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In need of dissolution equipment?

Industry news

Alliance Calibrations Group and Logan Instruments Form Partnership

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

Agilent Dissolution Vessels—the TruAlign Difference

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

Agilent 280-DS MQS Capabilities Extended

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

Hanson Research Acquired by Teledyne Instruments

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

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

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

November 2016 volume 23 issue 4

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In need of dissolution equipment?

Industry news

Agilent Dissolution Systems Digital Source Book Now Available

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

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

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

Hanson Research Releases New Phase One™ Disintegration Tester

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

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

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

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

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

Dissolution Accessories Appoints Vortex as Its U.S. Distributor

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

August 2016 volume 23 issue 3

A Brief Review of the FDA Dissolution Methods Database

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In need of dissolution equipment?

Industry news

850-DS 8-Channel Filter Plates

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

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

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

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

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

Simulations Plus Releases DDDPlus Version 5.0

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

Hanson Research to Host USP Dissolution Courses October/November 2016

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

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

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

Distek, Inc. Releases BIOne Single-Use Bioreactor System

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

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

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

ERWEKA Presented Three New Products at Analytica in Munich

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

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

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

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

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

Nanomedicines: Technical and Regulatory Perspectives Workshop

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

May 2016 volume 23 issue 2

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In need of dissolution equipment?

Industry news

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

April 6, 2016—With the success of the SUS-4000 Suspension System, Logan Instruments Corp. has advanced its design to accommodate USP 4 testing methods within the same system. In operation, the dry heat module stays in the horizontal position for suspension-cell tests. For USP 4 application, the dry heat module is moved to the vertical position, where end users can insert flow-through cells. Full article

Redefining Dissolution Qualification

Originally webcast on January 26th, 2016, to a wide audience, this webinar provides an in-depth examination of the USP Performance Verification Test and the ramifications of moving to the enhanced Mechanical Qualification (eMQ) alternative. Viewers will gain insight to the historical background and current practices regarding qualification of USP Dissolution Apparatus 1 and 2 as well as an improved model moving forward. Full article

Pion Inc. Acquires the Service Business of Vortex Sales Group

Billerica, MA, USA—April 6, 2016—Pion Inc. announced today the acquisition of the services division of Vortex Sales Group on February 2, 2016. Financial terms of the deal have not been disclosed. With the acquisition of these service contracts and service and support team members, Pion Inc. is broadening its offerings into the pharmaceutical laboratory with new instrumentation services geared toward the Analytical R&D and Quality Control laboratories. Full article

Desk Book of Pharmaceutical Dissolution Science and Applications

Question: What can you expect when expert scientists across the globe come together to publish a book on pharmaceutical dissolution science and applications? Answer: A masterpiece book—Desk Book of Pharmaceutical Dissolution Science and Applications. Full article

Hanson Research Launches New HRCare 360 Support Program

Los Angeles, CA—May 9, 2016—Hanson Research Corporation today announced the launch of HRCare 360 Support, a comprehensive program covering all dissolution and diffusion testing systems manufactured by Hanson Research. The release comes in the same year as Hanson's announcement of a three-year warranty for all instruments sold in 2016 in celebration of its 65th year in business. Full article

Distek, Inc., Celebrates 40 Years in Business

North Brunswick, NJ—March 22, 2016—Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories, and validation services, is proud to celebrate 40 years in business. Full article

Distek, Inc., Releases Next Generation Sample Probe & Filter for Manual and Semi-Automated Sampling

North Brunswick, NJ—February 23, 2016—Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories, and validation services, announced today the release of its next generation sample probe and filter as the preferred product for manual and semi-automated sampling. Full article

February 2016 volume 23 issue 1

Dissolution Model Development: Formulation Effects and Filter Complications

This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Full article

Ragna Berthelsen1 René Holm2 Jette Jacobsen1 Jakob Kristensen3 Bertil Abrahamsson4 Anette Müllertz11,5
1Department of Pharmacy, University of Copenhagen, Denmark
2Biologics and Pharmaceutical Sciences, H. Lundbeck A/S, Copenhagen, Denmark
3cJakob Pharma, Seattle, WA, USA
4AstraZeneca Pharmaceutics, R&D, Mölndal, Sweden
5Bioneer: FARMA, Department of Pharmacy, University of Copenhagen, Denmark
In Vitro Dissolution Curve Comparisons: A Critique of Current Practice

We review previously published work on dissolution profile similarity testing and provide a detailed critique of current methods in order to set the stage for a Bayesian approach. Full article

Dave LeBlond1 Stan Altan2 Steven Novick3 John Peterson4 Yan Shen2 Harry Yang5
1CMC Statistics Consultant, Wadsworth, IL 60083
2Janssen Research & Development LLC, Raritan, NJ 08869
3GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC 27709
4GlaxoSmithKline Pharmaceuticals, Collegeville, PA 19426
5MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
pH Dependence of the Dissolution Rate of EntericCoated Drug Spheres Determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Enteric coatings are widely used in formulations of drug delivery spheres. The coating protects an active pharmaceutical ingredient (API) from acidic conditions in the low pH environment of the stomach. Full article

Rachel Evans-Hurson1 Seán McSweeney1 Bastiaan Vos1 Jacob Krüse2 J. J. Keating1,3 Dara Fitzpatrick1
1Department of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland
2Kinetox, Beilen, The Netherlands
3School of Pharmacy, University College Cork, Ireland
Modulation of pH-Independent Release of a Class II Drug (Domperidone) from a Polymeric Matrix Using Acidic Excipients

Drug release from polymeric matrix systems is the rate-limiting step for drug bioavailability and is determined by drug solubility; most drugs show pH-dependent solubility. Full article

Amjad Khan1 Zafar Iqbal2 Abad Khan3 Muhammad Akhlaq Mughal2 Abbas Khan2 Zia Ullah2 Ismail Khan2
1Department of Pharmacy, Abasyn University, Peshawar-25120, Pakistan
2Department of Pharmacy, University of Peshawar, Peshawar-25120, Pakistan
3Department of Pharmacy, University of Swabi, Swabi, Pakistan
Influence of Various Media on the Dissolution Profiles of Immediate-Release Quetiapine Tablets in India

Dissolution testing was performed to evaluate the drug release from tablets. To mimic actual in vivo conditions, various foods and beverages were added to the dissolution media, and the release profiles were investigated. Indian people tend to have milk, curds, or eggs during their meals and then take their medications immediately after meals, whereas Americans tend to take medications with beverages. Full article

Zubin Shah1 Vaishali Londhe1
1Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, India
AAPS Focus Group
Meeting Report: AAPS In Vitro Release and Dissolution Testing Focus Group Face-to-Face Meeting

The AAPS In Vitro Release and Dissolution Testing (IVRDT) Focus Group had a Face-to-Face (F2F) Meeting on November 19, 2015, hosted by Bristol-Myers Squibb in New Brunswick, NJ. Xujin Lu (Bristol-Myers Squibb) was the Chair of the Organizing Committee, and the other members were Nikoletta Fotaki (University of Bath), Marie DiMaso (Corealis Pharma), and Vivian Gray (V. A. Gray Consulting). Full article

Vivian Gray1 Xujin Lu2 Jian-Hwa Han3 Dorys Diaz4 Geoffrey Grove5
1Dissolution Technologies, Hockessin, DE, USA
2Bristol-Myers Squibb, New Brunswick, NJ, USA
3AbbVie, North Chicago, IL, USA
4Pfizer, Groton, CT, USA
5Sotax, Westborough, MA, USA
Questions and Answers

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

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

In need of dissolution equipment?

Industry news

Upcoming Audit? Get Prepared with the New Dissolution Workstation

Software The new Agilent Dissolution Workstation software can help you meet your regulatory requirements. This paperless, compliant solution organizes all your dissolution methods and test data while controlling access and preventing unwarranted changes or errors. There’s no easier way to satisfy the necessary requirements for data storage and traceable records than this easy-to-implement software solution. Full article

Expanding In Product Development for Logan Instruments Corp. with Balloon Catheter Instrumentation and More

Somerset, NJ—January 17, 2016—Logan Instruments Corp. has diversified its portfolio through the expanding use of their Disso III-7 instrument. This year Logan Instruments Corp. has worked with customers on the development of instrumentation for the characterization and testing of combination products. With vast engineering knowledge, Logan Instruments Corp. has provided customers with Disso III-7 equipment for the evaluation of balloon catheters without the large cost of reinventing a brand new system. Full article

Pharma Test Announces Acquisition of J&M

Hainburg, Germany—January 2016—Pharma Test Apparatebau AG, a leader in the field of high-quality testing equipment for the pharmaceutical industry, announced today that it has acquired J&M Analytik AG, a German manufacturer and developer of fiberoptic diode-array spectrometer systems for laboratory and process applications. Full article

Hanson Research Announces Three-Year Warranty for Release-Rate Testing Instruments

Los Angeles, CA—February 1, 2016—Hanson Research announced today that it has increased the warranty period on its dissolution testing and diffusion testing instruments from one year to three years at no additional cost for all purchases invoiced and shipped during 2016. The 65th Anniversary Warranty program triples the industry average of one year, and in conjunction with Hanson Research’s global network of service and support professionals, it provides increased peace of mind and greater security for investments in laboratory equipment. Full article

USP Releases Online Database of Dissolution Methods

Rockville, MD-December 16, 2015—The USP Dissolution Methods Database is now available online. The database contains the test conditions (except Tolerances or Acceptance Criteria) as stated in the sections of the United States Pharmacopeia—National Formulary (USP-NF) referring to dissolution, disintegration, or drug release tests in the respective USP drug product monograph. Full article

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