2011 Issues

Practical Considerations for the Development of a Robust Two-Step Dissolution Test for Enteric-Coated Immediate- and Extended- Release Solid Oral Dosage Formulations

Henry Zhao¹, Stephen Cafiero¹, Zeena Williams¹, and Kevin C. Bynum^2
1Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT
²OSI Pharmaceuticals, Cedar Knolls, NJ

Development of a Single In Vitro Dissolution Method for a Combination Trilayer Tablet Formulation of Clopidogrel and Pravastatin

Zongyun Huang¹, Ruben Lozano¹, Robert Francis¹, Anne-Françoise Aubry², Alyson Steckbeck¹, and Denis O. Sciascia^1
1Bristol-Myers Squibb, Research and Development, New Brunswick, NJ USA
²Bristol-Myers Squibb, Research and Development, Lawrenceville, NJ USA

Comparison of the Rupture and Disintegration Tests for Soft-Shell Capsules

May Almukainzi¹, Mahnor Salehi¹, Nadia A. B. Chacra², and Raimar Löbenberg^1
1Faculty of Pharmacy & Pharmaceutical Science, University of Alberta, Edmonton, Alberta, Canada
²Department of Pharmaceutical Science, University of Sao Paulo, Brazil

Evaluation of In Vitro Equivalence for Drugs Containing BCS Class II Compound Ketoprofen

I. E. Shohin^1,2, J. I. Kulinich^1,2, G. V. Ramenskaya^1,2, and G. F. Vasilenko^2
1Sechenov First Moscow State Medical University, Moscow, Russia
²Scientific Center for Expertise of Medical Products, Moscow, Russia

Biopharmaceutics Classification System: A Regulatory Approach

B. Basanta Kumar Reddy¹ and A. Karunakar^2
1Regulatory Affair Dpt., Indchemie Health Specialities Pvt. Ltd., (Alkem Research Laboratory), Mumbai, India
²Regulatory Affair Department, Dr. Reddy's Laboratory, Hyderabad, India

Dissolution Enhancement and Physicochemical Characterization of Valsartan in Solid Dispersions with β-CD, HP β-CD, and PVP K-30

Anjan K. Mahapatra¹, P. N. Murthy², Sudarsan Biswal², Abikesh P. K. Mahapatra², and Siba P. Pradhan^3
1School of Pharmaceutical Education and Research, Berhampur University, Berhampur, INDIA
²Royal College of Pharmacy and Health Sciences, Berhampur, INDIA
³Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh, Assam, INDIA

USP: Tribute to Thomas Foster

Vivian Gray
Dissolution Technologies, Hockessin, DE

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD

Overview of Dissolution Instrument Qualification, Including Common Pitfalls

Gregory P. Martin¹ and Vivian A. Gray^2
1Complectors Consulting LLC, Pottstown, PA
²V. A. Gray Consulting, Hockessin, DE

Practical Aspects of Dissolution Instrument Qualification - A European Perspective

Johannes Kraemer and Rolf Schwan
PHAST, Homburg, Germany

Feasibility Study on Qualification of USP Dissolution Apparatus 1 and 2 Using the Enhanced Mechanical Calibration Procedure

Brian Yan, Xujin Lu, and Ruben Lozano
Analytical & Bioanalytical Development, Bristol-Myers Squibb Company New Brunswick, NJ

Enhanced Mechanical Calibration of Dissolution Test Equipment

Alger Salt¹ and John Glennon^2
1GlaxoSmithKline, Product Development Laboratory Automation and Platforms, Research Triangle Park, NC
²GlaxoSmithKline, Global Manufacturing and Supply, Shared Stability Services, Zebulon, NC

Commentaries from Dissolution Tester Equipment Manufacturers on Enhanced Mechanical Calibration (MC) and Performance Verification Standards (PVT)

Vivian A. Gray
Dissolution Technologies, Hockessin, DE

Report on the IVRDT Dissolution Instrument Qualification Survey

Geoffrey N. Grove
SOTAX Corporation, Hopkinton, MA

2010 Pharmaceutical Sciences World Congress Provides Dissolution Programming with an International Flavor

Gregory P. Martin¹, Nikoletta Fotaki², Alger D. Salt³, and Vivian A. Gray^4
1Complectors Consulting LLC, Pottstown, PA
²Department of Pharmacy and Pharmacology, University of Bath, UK
³GlaxcoSmithKline, Raleigh, NC
⁴Dissolution Technologies, Hockessin, DE

USP Update: New USP PVT Subcommittee and Archived Webinar

Will Brown and Erika Stippler
USP, Rockville, MD, USA

BOOK REVIEW: Dissolution Technologies Questions and Answers

Ge Bai
MedImmune LLC, Gaithersburg, MD

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD

Intrinsic Dissolution as a Tool for Evaluating Drug Solubility in Accordance with the Biopharmaceutics Classification System

Michele G. Issa and Humberto G. Ferraz Pharmacy Department, Pharmaceutical Sciences School, University of São Paulo, São Paulo, Brazil

Corrigendum to "Feasibility Study on Qualification of USP Dissolution Apparatus 1 and 2 Using the Enhanced Mechanical Calibration Procedure"

Brian Yan, Xujin Lu, and Ruben Lozano
Analytical & Bioanalytical Development, Bristol-Myers Squibb Company, New Brunswick, NJ 08903-0191

Simulated Biological Fluids with Possible Application in Dissolution Testing

Margareth R. C. Marques¹, Raimar Loebenberg², and May Almukainzi^2
1U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD USA
²Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta, Canada

Drug Transport Mechanisms from Carbopol/Eudragit Verapamil Sustained-Release Tablets

Sandile M. Khamanga and Roderick B. Walker
Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa

Formulation and Optimization of Nanosuspensions for Enhancing Simvastatin Dissolution Using Central Composite Design

Vikram M. Pandya¹, Jayvadan K. Patel², and Dhaval J. Patel^3
1B.S.Patel Pharmacy College, Linch, Mehsana, Gujarat, India
²Nootan Pharmacy College, Gujarat, India
³Shree Krishna Institute of Pharmacy, Shankhalpur, Mehsana, Gujarat, India

Dissolution Method for Milnacipran Hydrochloride Capsules: Development, Validation, and Study of Changes in Dissolution Rate after Storage

Carolina Lupi Dias, Rochele Cassanta Rossi, Lisiane Bajerski, and Pedro Eduardo Fröehlich
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS). Av. Ipiranga, Porto Alegre, Brasil

Studies in Dissolution Enhancement of Ezetimibe by Solid Dispersions in Combination with a Surface Adsorbent

Komal R. Parmar, Sunny R. Shah, and Navin R. Sheth
Department of Pharmaceutical Sciences, Saurashtra University, Gujarat, India

Dissolution Behavior and Thermodynamic Stability of Fused-Sugar Dispersions of a Poorly Water-Soluble Drug

Ghanshyam Singh, Gulshan Chhabra, and Kamla Pathak
Department of Pharmaceutics, Rajiv Academy for Pharmacy, Chattikara, Mathura Uttar Pradesh, India

Gastroretentive Orlistat Microspheres: Formulation, Characterization, and In Vitro Evaluation

S. B. Sateesha¹, B. Prakash Rao1, A. J. Rajamma², and L. V. G. Nargund^3
1Department of Pharmaceutics, Acharya and BM Reddy College of Pharmacy, Bangalore, India
²Department of Pharmacognosy, KLE University College of Pharmacy, Bangalore, India
³Department of Pharmachemistry, Nargund College of Pharmacy, Bangalore, India

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD

Hydrodynamic Complexity Induced by the Pulsing Flow Field in USP Dissolution Apparatus 4

Deirdre M. D'Arcy¹, Bo Liu¹, Tim Persoons², and Owen I. Corrigan^1
1School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland
²Department of Mechanical and Manufacturing Engineering, Trinity College Dublin, Dublin, Ireland

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

Catharina Wähling, Christian Schröter, and Andrea Hanefeld
Merck KGaA, CMC Development, Darmstadt, Germany

Biorelevant Dissolution Testing of Drug-Eluting Stents: Experiences with a Modified Flow-Through Cell Setup

Anne Seidlitz¹, Stefan Nagel¹, Beatrice Semmling¹, Niels Grabow², Katrin Sternberg², and Werner Weitschies^1
1Institute of Pharmacy, Biopharmaceutics and Pharmaceutical Technology, EMA University of Greifswald, Germany
²Institute for Biomedical Engineering, University of Rostock, Germany

A Novel Method for the Elution of Sirolimus (Rapamycin) in Drug-Eluting Stents

M. Merciadez, L. Alquier, R. Mehta, A. Patel, and A. Wang
Cordis, A Johnson & Johnson Company, Warren, NJ USA

Review of Research Paper: Development of a Performance Verification Test for USP Apparatus 4

Erika S. Stippler
US Pharmacopeial Convention, Rockville, MD USA

Flow-Through Cell Apparatus (USP Apparatus 4): Operation and Features

Nikoletta Fotaki
Department of Pharmacy & Pharmacology, University of Bath, Bath, UK

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

Cynthia K. Brown¹, Horst Dieter Friedel², Amy R. Barker¹, Lucinda F. Buhse³, Susanne Keitel⁴, Todd L. Cecil⁵, Johannes Kraemer⁶, J. Michael Morris⁷, Christos Reppas⁸, Mary P. Stickelmeyer¹, Chikako Yomota⁹, and Vinod P. Shah^10
1Eli Lilly and Company, Indianapolis, Indiana, USA
²Bayer HealthCare AG, Berlin, Germany
³Food and Drug Administration/CDER/OPS, St. Louis, Missouri, USA
⁴EDQM, Council of Europe, Strasbourg, France
⁵United States Pharmacopeia, Rockville, Maryland, USA
⁶PHAST, Homburg, Germany
⁷Irish Medicines Board, Dublin, Ireland
⁸National & Kapodistrian University of Athens, Panepistimiopolis, Greece
⁹National Institute of Health Science, Tokyo, Japan
¹⁰FIP Scientific Secretary, The Hague, Netherlands

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD