Comparative bioavailability of two flurbiprofen products: stereospecific versus conventional approach.
Author(s): Jamali F, Collins DS, Berry BW, Molder S, Cheung R, McColl K, Cheung H
Affiliation(s): Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada.
Publication date & source: 1991-08, Biopharm Drug Dispos., 12(6):435-45.
Publication type: Clinical Trial; Comparative Study ; Randomized Controlled Trial
In this randomized, crossover study comparing the bioavailability of a film-coated (Ansaid) with a sugar-coated (Froben) 100 mg tablets of racemic flurbiprofen in 23 healthy young men, no significant differences were found for Cmax, tmax or AUC, using a nonstereoisomeric assay for flurbiprofen. Minor differences in the appearance of flurbiprofen in serum during the first 30-min post-dosing period were noted, with Ansaid appearing earlier than Froben. These differences likely reflect dissolution rate dissimilarity between the two products. Stereospecific determinations demonstrate a small (7.8 per cent) but significant difference in AUC of the active S-configuration (Froben greater than Ansaid). No significant differences between Ansaid and Froben were found for tmax or Cmax for the S-flurbiprofen. In bioequivalency studies of chiral drugs, stereospecific approaches provide a more accurate assessment of products.
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