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.