Bioequivalence of topical clotrimazole formulations: an improved tape stripping method.

ABSTRACT

PURPOSE: Investigations were carried out to assess the use of tape stripping (TS) for the determination of bioequivalence of topical products containing 1% clotrimazole. METHODS: The study design involved the establishment of an appropriate application time, which was determined by conducting a dose duration study. Subsequently, two bioequivalence studies were conducted i) using the brand (Canesten Topical - 1% clotrimazole cream) as both the test and the reference product and ii) comparing Canesten cream with a gel product containing the same concentration of clotrimazole (1%). Each tape strip was individually analyzed for clotrimazole content using an HPLC method and Transepidermal Water Loss (TEWL) measurements were used to normalize the stratum corneum thicknesses between subjects. RESULTS: The results of the TS investigations showed that, if the study is sufficiently powered, tape stripping may be used to determine bioequivalence according to the conventional bioequivalence limits of 0.8-1.25, as well as detect formulation differences between different clotrimazole products. CONCLUSIONS: The data from this study provided compelling evidence that tape stripping has the necessary attributes and potential to be used as a tool for the bioequivalence assessment of topical clotrimazole and/or other topical formulations, thereby circumventing the need to undertake expensive and time-consuming clinical trials for such products. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.