Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol.
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).
Vogelpoel
H
H
RIVM-National Institute for Public Health and the Environment, Center for Quality of Chemical-Pharmaceutical Products, P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
Welink
J
J
Amidon
G L
GL
Junginger
H E
HE
Midha
K K
KK
Möller
H
H
Olling
M
M
Shah
V P
VP
Barends
D M
DM
D000284:Administration, Oral; D001262:Atenolol / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001702:Biopharmaceutics / Q000145:classification*; D004304:Dosage Forms; D006801:Humans; D007408:Intestinal Absorption; D011433:Propranolol / Q000008:administration & dosage* / Q000493:pharmacokinetics; D012995:Solubility; D013810:Therapeutic Equivalency; D014700:Verapamil / Q000008:administration & dosage* / Q000493:pharmacokinetics
D004304:Dosage Forms; D001262:Atenolol; D011433:Propranolol; D014700:Verapamil