Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. Potthast, H., Dressman, J. B., Junginger, H. E., Midha, K. K., Oeser, H., Shah, V. P., Vogelpoel, H., & Barends, D. M. J Pharm Sci, 94(10):2121–31, October, 2005. doi abstract bibtex 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.
@article{potthast_biowaiver_2005-1,
title = {Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen},
volume = {94},
issn = {0022-3549 (Print) 0022-3549 (Linking)},
doi = {10.1002/jps.20444},
abstract = {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.},
number = {10},
journal = {J Pharm Sci},
author = {Potthast, H. and Dressman, J. B. and Junginger, H. E. and Midha, K. K. and Oeser, H. and Shah, V. P. and Vogelpoel, H. and Barends, D. M.},
month = oct,
year = {2005},
keywords = {*Intestinal Absorption, Administration, Oral, Anti-Inflammatory Agents, Non-Steroidal/administration \&, Biopharmaceutics/*classification, Databases, Bibliographic, Dosage Forms, Excipients/chemistry, Humans, Hydrogen-Ion Concentration, Ibuprofen/administration \& dosage/chemistry/*pharmacokinetics/standards, Solubility, Surface-Active Agents/chemistry, Therapeutic Equivalency, dosage/chemistry/*pharmacokinetics},
pages = {2121--31},
}
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