Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol

✍ Scribed by H. Vogelpoel; J. Welink; G.L. Amidon; H.E. Junginger; K.K. Midha; H. Möller; M. Olling; V.P. Shah; D.M. Barends

• Book ID: 102400984
• Publisher: John Wiley and Sons
• Year: 2004
• Tongue: English
• Weight: 123 KB
• Volume: 93
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.20131

✦ Synopsis

Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA's the assumption was made that these tablets were bioequivalent to the innovator product. The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP).