Comparative bioavailability of two flurbiprofen products: Stereospecific versus conventional approach

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Abstract
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 > 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.