Evaluation of In Vitro Equivalence for Drugs Containing BCS Class II Compound Ketoprofen

This paper describes the evaluation of the in vitro equivalence of capsules containing a BCS Class II compound, k etoprofen, marketed in Russia under biowaiver conditions and the innovator product. The in vitro equivalence test was carried out according to WHO Technical Report Series, No. 937, Annex 8. Dissolution profiles of test and reference (innovator) ketoprofen capsules are considered equivalent at pH 6.8 without statistical treatment, equivalent at pH 4.5 (f1 = 3 and f2 = 80), and not equivalent at pH 1.2 (f1 = 22 and f2 = 41). Generally, the evaluated capsules did not meet biowaiver criteria for drugs containing BCS Class II API, possibly due to the effect of surfactant (sodium lauryl sulfate) contained in the test preparation on the solubility.