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

• Published in: Journal of pharmaceutical sciences Vol. 93; no. 8; p. 1945
• Main Authors: Vogelpoel, H, Welink, J, Amidon, G L, Junginger, H E, Midha, K K, Möller, H, Olling, M, Shah, V P, Barends, D M
• Format: Journal Article
• Language: English
• Published: United States 01-08-2004
• Subjects: Administration, Oral; Atenolol - administration & dosage; Atenolol - pharmacokinetics; Biopharmaceutics - classification; Dosage Forms; Humans; Intestinal Absorption; Propranolol - administration & dosage; Propranolol - pharmacokinetics; Solubility; Therapeutic Equivalency; Verapamil - administration & dosage; Verapamil - pharmacokinetics
• ISSN: 0022-3549
• DOI: 10.1002/jps.20131

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).