2005 Issues

February 2005 Volume 12 Issue 1


USP Dissolution Calibrators: Re-examination and Appraisal

Tom Foster and Will Brown
USP, Rockville, MD

Evaluation of Dissolution Hydrodynamics in the USP, Peak™ and Flat-Bottom Vessels Using Different Solubility Drugs

Tahseen Mirza, Ph.D,Yatindra Joshi, Ph.D, Qian (Julie) Liu, Ph.D. and Richard Vivilecchia, Ph.D.
Pharmaceutical and Analytical Development,Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ

Geometric Irregularities Common to the Dissolution Vessel

Peter Scott
Quality Assurance Sciences, AstraZeneca,Westborough, MA

Comparison of the Adsorption of Several Drugs to Typical Filter Materials

Marc Lindenberg1, Cornelia Wiegand2, Jennifer B. Dressman1
1. Department of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main,Germany
2. Schleicher & Schuell MicroScience GmbH,Dassel,Germany

Evaluation of Induced Variance of Physical Parameters on the Calibrated USP Dissolution Apparatus 1 and 2

Bryan Crist and Dan Spisak
Varian Inc., Analytical Instruments, Cary, NC

Observations of Systematic Errors in Calibrator Tablet Testing

John Burmicz
Pharma Test Apparatebau GmbH,Hainburg,Germany

Activities of the USP Project Team on Dissolution Calibration

USP, Rockville,MD

AAPS In Vitro Release and Dissolution Focus Group ñ First Meeting Highlights

Vivian Gray
Dissolution Technologies, Hockessin, DE

Question & Answer Section

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

May 2005 Volume 12 Issue 2

Special Edition on Flow Through Cell, USP Apparatus 4


A Comparison of Dissolution Testing on Lipid Soft Gelatin Capsules Using USP Apparatus 2 and Apparatus 4

Jack Hu,Ali Kyad,Vivian Ku, Peter Zhou ,Nina Cauchon
Pharmaceutics Department, Amgen Inc.,One Amgen Center Drive,Thousand Oaks, CA

Application of USP Apparatus 4 and In Situ Fiber Optic Analysis to Microsphere Release Testing

B. S. Zolnik1, J-L. Raton2, and D. J. Burgess1
1Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT USA, 06269
2Sotax AG Basel, Binningerstr 106 CH-4123 Allschwil 1, Switzerland

The Flow Through Cell Methodology in the Evaluation of Intralumenal Drug Release Characteristics

Nikoletta Fotaki and Christos Reppas
School of Pharmacy, Laboratory of Biopharmaceutics and Pharmacokinetics, University of Athens, Panepistimiopolis, 157 71 Zografou,Greece

Dissolution Study of Active Pharmaceutical Ingredients Using the Flow Through Apparatus USP 4

E. Beyssac and J. Lavigne
ERT CIDAM, Biopharmaceutics Department, Faculty of Pharmacy, PO Box 38, 63000 Clermont-Ferrand, France

USP Apparatus 4 Flow Through Cell: Some Thoughts on Operational Characteristics

Will Brown
USP, Rockville,MD

Experiences with USP Apparatus 4 Calibration

Johannes Kr�mer and Erika Stippler
PHAST GmbH, , Kardinal-Wendel-Str. 16, 66424 Homburg/Saar,Germany

Qualification and Validation of USP Apparatus 4

Jon S. Kauffman, Ph.D., Director
Pharmaceutical Method Development and Validation, Lancaster Laboratories, 2425 New Holland Pike, Lancaster, PA 17605

Simultaneous Sampling and HPLC Injection from USP Apparatus 4 using a Dual Sampling Rack

Dr.Andrew Hodson and Keith A Wilkinson
Icalis Data Systems LTD., Berkshire,UK

Question & Answer Section

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

August 2005 Volume 12 Issue 3


Effects of Dissolved Gases in Surfactant Dissolution Media

Kyle A. Fliszar*, Richard J. Forsyth, Zhong Li, Gregory P. Martin
Pharmaceutical Analysis & Control, PR&D, Merck & Co.,West Point, PA

Dissolution Method Development for Immediate Release Solid Oral Dosage Forms

David Fortunato
Johnson and Johnson Pharmaceutical Research and Development, Spring House, PA

Highlights of AAPS in Vitro Release and Dissolution Testing Focus Group Meeting

Vivian A. Gray1 and Diane Worrell2
1V. A. Gray Consulting, Inc,Hockessin, DE
2Manager, Analytics-Dissolution, Quintiles, Inc., Kansas City, MO

USP Dissolution Test with Pooled Samples, Statistical Analysis of the Third Stage

Nora S. Meneces, Carlos D. Saccone and Julio Tessore
University of the Republic of Uruguay, Faculty of Engineering, Industrial Production Department, Montevideo,Uruguay

Question & Answer Section

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

Letter to the Editor

November 2005 Volume 12 Issue 4


Dissolution Testing of Poorly Soluble Drugs: PhRMA Workshop Report

Effect of the Irregular Inner Shape of a Glass Vessel on Prednisone Dissolution Results

Makoto Tanaka, Hiroyasu Fujiwara, and Morimasa Fujiwara
Takao Manufacturing Co., Ltd. 62, Nihonmatsu-cho,Yoshida, Sakyo-ku, Kyoto, Japan

Assessment of Similarity Factor Using Different Weighting Approaches

Mukesh C.Gohel, Krishnakant G. Sarvaiya, Neelima R. Mehta, Chirag D. Soni, Vinita U. Vyas and Rikita K. Dave
L. M.College of Pharmacy, Navrangpura, Ahmedabad, INDIA

Controlled Release Society Annual Meeting Report: Dissolution Highlights

Sandra Klein, Ph.D.
Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology, Frankfurt,GERMANY

Question & Answer Section

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

Letter to the Editor