Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen.
Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in composition and/or manufacturing procedures were reported to have an effect on the rate, but not the extent of absorption; such differences are likely to be detectable by comparative in vitro dissolution tests. Also in view of its therapeutic use, its wide therapeutic index and uncomplicated pharmacokinetic properties, a biowaiver for immediate release (IR) ibuprofen solid oral drug products is scientifically justified, provided that the test product contains only those excipients reported in this paper in their usual amounts, the dosage form is rapidly dissolving (85% in 30 min or less) in buffer pH 6.8 and the test product also exhibits similar dissolution profiles to the reference product in buffer pH 1.2, 4.5, and 6.8.
Potthast
H
H
Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger-Allee 3, Bonn, Germany.
Dressman
J B
JB
Junginger
H E
HE
Midha
K K
KK
Oeser
H
H
Shah
V P
VP
Vogelpoel
H
H
Barends
D M
DM
D000284:Administration, Oral; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D001702:Biopharmaceutics / Q000145:classification*; D016206:Databases, Bibliographic; D004304:Dosage Forms; D005079:Excipients / Q000737:chemistry; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007052:Ibuprofen / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics* / Q000592:standards; D007408:Intestinal Absorption; D012995:Solubility; D013501:Surface-Active Agents / Q000737:chemistry; D013810:Therapeutic Equivalency
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004304:Dosage Forms; D005079:Excipients; D013501:Surface-Active Agents; D007052:Ibuprofen