2001 Issues

Volume 8, Issue 1, February 2001







Industry News:
- USP Revises Acceptance Range for Prednisone Calibrator Tablets Lot M

Dissolution Testing of Veterinary Products:
- Dissolution Testing of Sulfa Boluses

- Dissolution Testing of Aspirin Boluses
- Dissolution Testing of Tetracycline Boluses
Raafat Fahmy1, William Marnane1, Dennis Bensley1 and R. Gary Hollenbeck2
1Center for Veterinary Medicine, Food and Drug Administration,
Rockville, MD
2Department of Pharmaceutical Sciences, University of Maryland
School of Pharmacy, Baltimore, MD

Meeting News:
- AAPS Workshop: Assuring Quality
and Performance of Sustained and Controlled Release Parenterals
- AAPS Workshop: Dissolution:
Current and Emerging Practices - Methodology, Technology and Regulatory Issues


Volume 8, Issue 2, May 2001


Thoughts on Fiber Optics in Dissolution Testing
Schatz C.1, 2, Ulmschneider M.,1 Altermatt R.,1 Marrer S.1, 2 and Altorfer H.1, 2
1 Pharmaceutical Quality Control and Quality Assurance, F. Hoffmann-La Roche Ltd., Basel, Switzerland
2 Pharmaceutical Analysis, Swiss Federal Institute of Technology, Zurich, Switzerland


Qualification of a Zymark®, MultiDose® Automated Dissolution Workstation for Dissolution Testing of Fexofenadine HCl Capsules
Tom A. Steinman and Ernest Parente, Ph.D.
Quality Control, Aventis Pharmaceuticals, Inc., Kansas City, MO


Meeting News:
International "Hands On" Dissolution & Bioequivalence Workshops in India



Volume 8, Issue 3, August 2001

Dissolution Method Development for Poorly Soluble Compounds

Brian R. Rohrs, Ph.D.
Pharmacia, Kalamazoo, MI

Dissolution Fit Factors as Response Variables in Statistically Designed Experiments

Henry H. Flanner,(1) Charles F. Vesey,(2) and Joseph R. Loehe,(3)
(1) Drug Delivery Sciences, Shire Laboratories, Inc., Rockville, MD
(2) New Product Development, Colorcon, West Point, PA
(3) Consulting Chemical Engineer, Ellicott City, MD

Intrinsic Drug Dissolution Testing Using the Stationary Disk System

Tacey X. Viegas,(1) Roxanne U. Curatella,(1) Lise L. VanWinkle(1) and Gerald Brinker(2)
(1) BioCryst Pharmaceuticals, Inc., Birmingham, AL
(2) Distek, Inc., North Brunswick, NJ

Volume 8, Issue 4, November 2001


Dissolution: A Quality Control Test vs. A Bioequivalence Test

Vinod P. Shah, Ph. D.
Office of Pharmaceutical Science, Center for Drug
Evaluation and Research
Food and Drug Administration
Rockville, MD

A Comparison of Dissolution Results Using O-Ring vs. Clipped Basket

Vivian Gray, Mary Beggy, Robert Brockson, Nancy Corrigan and John Mullen
Bristol-Myers Squibb Company
Wilmington, DE

Analytical Performance of a Fiber Optic Probe Dissolution System

Kevin Bynum,1 Kurt Roinestad,1 Abe Kassis,1 John Pocreva,2 Lane Gehrlein,1 Frank Cheng,1 Philip Palermo,1 1 Purdue Pharma LP, International Research and Development Center, Ardsley, NY
2 Emisphere Technologies Inc., Tarrytown, NY 10591