Privatsphäre-Einstellungen

FIP/AAPS Guidelines for Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

Dr. Martin Siewert¹, Prof. Dr. Jennifer Dressman², Cynthia K. Brown³, and Dr. Vinod P. Shah⁴

1 Aventis Pharma AG, Frankfurt/Main (Germany)
2 Johann Wolfgang Goethe University, Frankfurt/Main (Germany)
3 Eli Lilly and Company, Indianapolis, I N (USA)
4 Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD (USA)

In the pharmaceutical industry, dissolution testing is a very important tool in drug development and quality control. Although initially developed for immediate release (IR) solid oral dosage forms and then extended to controlled/modified release solid oral dosage forms, in recent years the application of dissolution testing has widened to a variety of “novel” or “special” dosage forms. The in vitro drug release test for some novel/special dosage forms such as semi-solid dosage forms and transdermal drug delivery systems has proven to be equally valuable as the dissolution test for solid oral dosage forms. The in vitro drug release test also shows promise for other dosage forms, such as chewable tablets, suspensions and suppositories. For yet other dosage forms, such as chewing gums, powders, and parenterals, further method development and refinement will be needed to make the drug release test a generally applicable, robust and valuable tool.This article represents the scientific opinion of many experts and, in particular, is derived from a series of workshops held under the auspices of FIP co-sponsored by the Royal Pharmaceutical Society (UK), BPI Colloqium Pharmaceuticum (Germany), AAPS American Association of Pharmaceutical Scientists (US) and the Food and Drug Administration (US). It is now presented as an FIP and AAPS position paper to support activities, programs and decisions in the scientific, technical and regulatory community.