FIP Guidelines for Dissolution Testing of Solid Oral Products

• Published in: Journal of pharmaceutical sciences Vol. 107; no. 12; pp. 2995 - 3002
• Main Authors: Friedel, Horst Dieter, Brown, Cynthia K., Barker, Amy R., Buhse, Lucinda F., Keitel, Susanne, Kraemer, Johannes, Morris, John Michael, Reppas, Christos, Sperry, David C., Sakai-Kato, Kumiko, Stickelmeyer, Mary P., Shah, Vinod P.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.12.2018
• Subjects: automation; bioavailability; biopharmaceutics classification system (BCS); dissolution; drug delivery system(s); formulation; in vitro–in vivo correlation(s) (IVIVC); solid dosage form(s); surfactant(s); drug delivery system(s); automation; bioavailability; surfactant(s); dissolution; formulation; biopharmaceutics classification system (BCS); solid dosage form(s); in vitro–in vivo correlation(s) (IVIVC)
• ISSN: 0022-3549; 1520-6017; 1520-6017
• DOI: 10.1016/j.xphs.2018.08.007

Dissolution testing is an important physiochemical test for the development of solid oral dosage forms, tablets, and capsules. As a quality control test, the dissolution test is used for assessment of drug product quality and is specified for batch release and regulatory stability studies. In vitro dissolution test results can often be correlated with the biopharmaceutical behavior of a product.This article provides a summary of views from major global agencies (Europe, Japan, United States), pharmacopoeias, academia, and industry. Based on available guidance and literature, this article summarizes highlights for development and validation of a suitable dissolution method, setting appropriate specifications, in vitro–in vivo comparison, and how to obtain a biowaiver.