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 abs...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2005-10, Vol.94 (10), p.2121-2131
Main Authors: Potthast, H., Dressman, J.B., Junginger, H.E., Midha, K.K., Oeser, H., Shah, V.P., Vogelpoel, H., Barends, D.M.
Format: Article
Language:English
Subjects:
absorption
Administration, Oral
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Anti-Inflammatory Agents, Non-Steroidal - chemistry
Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics
Biopharmaceutics - classification
biopharmaceutics classification system(BCS)
Databases, Bibliographic
Dosage Forms
Excipients - chemistry
Humans
Hydrogen-Ion Concentration
ibuprofen
Ibuprofen - administration & dosage
Ibuprofen - chemistry
Ibuprofen - pharmacokinetics
Ibuprofen - standards
Intestinal Absorption
permeability
Solubility
Surface-Active Agents - chemistry
Therapeutic Equivalency
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Summary: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. © 2005 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 94:2121‐2131, 2005
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.20444