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)

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...