2011 Issues

February 2011 Volume 18 Issue 1


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. Bynum2
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. Sciascia1
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 Löbenberg1
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. Shohin1,2, J. I. Kulinich1,2, G. V. Ramenskaya1,2, and G. F. Vasilenko2
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. Karunakar2
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. Pradhan3
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

May 2011 Volume 18 Issue 2



Overview of Dissolution Instrument Qualification, Including Common Pitfalls

Gregory P. Martin1 and Vivian A. Gray2
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 Glennon2
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. Gray4
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

August 2011 Volume 18 Issue 3


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 Almukainzi2
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. Patel3
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. Nargund3
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

November 2011 Volume 18 Issue 4


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

Deirdre M. D'Arcy1, Bo Liu1, Tim Persoons2, and Owen I. Corrigan1
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 Weitschies1
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. Shah10
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