2004 Issues

February 2004 Volume 11 Issue 1


Comparison of the Effectiveness of Various Deaeration Techniques

Owen S. Degenhardt 1, Bonnie Waters 1,Anna Rebelo-Cameirao 1, Annelene Meyer 2,Heiko Brunner 2, and Nicholas P.Toltl 1
1. Eli Lilly Canada, Lilly Analytical Research Laboratories, Scarborough,Ontario, Canada
2. Lilly Research Laboratories, Lilly Forschung GmbH,Hamburg,Germany

Developing a Discriminating Dissolution Procedure for a Dual Active Pharmaceutical Product with Unique Solubility Characteristics

Lagace, M.,Gravelle, L., Di Maso, M. and McClintock, S.
Department of Pharmaceutical Research and Development, Merck Frosst Canada & Co., Kirkland,Quebec, Canada

Introduction to the Validation of a Dissolution Apparatus

Sharon M.Averell Frost
Wyeth Vaccines, Sanford,NC

PhRMA Establishes Dissolution Expert Team

Peter Scott
QA Analytical Services, Method Services, AstraZeneca,Westborough, MA

Question & Answer Section

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

Meeting Report: Conference on Dissolution, Bioequivalence, and Bioavailability

Tahseen Mirza 1 and Vivian Gray 2
1. Novartis Pharmaceuticals, East Hanover, NJ
2. V. A. Gray Consulting, Inc., Hockessin, DE

May 2004 Volume 11 Issue 2


Comparison of US Pharmacopeia Simulated Intestinal Fluid TS (without pancreatin) and Phosphate Standard Buffer pH 6.8,TS of the International Pharmacopoeia with Respect to Their Use in In Vitro Dissolution Testing

Erika Stippler 1,2, Sabine Kopp 3, Jennifer B. Dressman 1
1. J.W. Goethe University Frankfurt/Main,Department of Pharmaceutical Technology,Germany
2. PHAST GmbH,Homburg/Saar,Germany
3. World Health Organization,Geneva, Switzerland

In Vitro Release of Nicotine From Chewing Gum Formulations

Yamini Morjaria 1,William J. Irwin 1, Paul X. Barnett 2, Rick S. Chan 3, and Barbara Conway 1
1. Medicines Research Unit, Aston University, Birmingham, UK,
2. Glaxo SmithKline Consumer Healthcare, St.Georges Avenue,Weybridge,UK
3. Glaxo SmithKline Consumer Healthcare, 1500 Littleton Rd, Parsippany, New Jersey, USA

Dissolution Media Simulating Fasted and Fed States

Margareth Marques,United States Pharmacopeia, Rockville,MD

Meeting Report: AAPS/USP/CRS Workshop on Dissolution; New Technologies and Regulatory Initiatives

C. Jeanne Taborsky 1, and Vivian A. Gray 2
1. SciRegs, Columbia, MD
2. V. A. Gray Consulting, Inc.,Hockessin,DE

Question & Answer Section

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

August 2004 Volume 11 Issue 3


The Future of Dissolution Testing: USP,Academic, FDA, and Industry Perspectives

Dissolution: a Continuing Perspective Roger L.Williams, 1 and Thomas Foster, 2
1 Chair, Council of Experts
2 Chair, Biopharmaceutics Expert Committee United States Pharmacopeia, Rockville,MD

Future Directions for Academic Researchin Dissolution Testing
Jennifer B. Dressman
J.W. Goethe University, Frankfurt am Main,Germany

Role of Dissolution Testing: Regulatory Perspectives
Vinod P. Shah
Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration, Rockville,MD

Future Directions for Dissolution Testing in the Pharmaceutical Industry
Vivian A. Gray
Dissolution Technologies,Hockessin, DE

The Development and Validation of a Dissolution Method for Clomipramine Solid Dosage Forms

Mehdi Ansari 1,Maryam Kazemipour 2, and Javad Talebnia 1
1 Department of Pharmaceutics, Faculty of Pharmacy, Kerman Medical Sciences University, Kerman, Iran
2 Department of Chemistry, Faculty of Sciences, Kerman Azad University, Kerman, Iran

Statistical Properties of the Dissolution Test of the USP

Carlos D. Saccone 1, Julio Tessore 1, Silvino A. Olivera 2, and Nora S. Meneces 1
1 University of the Republic of Uruguay, Faculty of Engineering, Industrial Production Department, Montevideo,Uruguay
2 University of the Republic of Uruguay, Faculty of Chemistry, Estrella Campos Department, Montevideo,Uruguay

Question & Answer Section

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

November 2004 Volume 11 Issue 4


Measurement of Dissolved Oxygen as a Determination of Media Equilibrium During Dissolution Testing

Thomas Curley,Richard Forsyth, Susan Sun,Kyle Fliszar, Mitch Colletto and Gregory P.Martin
Pharmaceutical Analysis & Control, PR&D, Merck & Co.,West Point, PA

A New Crescent-shaped Spindle for Drug Dissolution Testing–But Why a New Spindle?

Saeed A. Qureshi, Ph.D.
Health Products and Food Branch, Health Canada,Ottawa, Canada

A More Relevant Dissolution Method for Evaluation of a Floating Drug Delivery System

Mukesh C.Gohel, Pavak R.Mehta, Rikita K. Dave and Nehal H. Bariya
Department of Pharmaceutics and Pharmaceutical Technology, L. M.College of Pharmacy, Ahmedabad, India

FIP/WHO/CHINA Bioequivalence and Hands-on- Dissolution Workshop Report

Vinod P. Shah, Ph.D.
FIP Scientific Secretary

Controlled Release Society Annual Meeting Report: Dissolution Highlights

Vivian Gray
Dissolution Technologies, Hockessin, DE

Question & Answer Section

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