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