We present a method to determine the cutaneous bioavailability and hence to evaluate the bioequivalence of topically applied drugs in vivo. The procedure uses serial tape-stripping and transepidermal water loss measurements to quantify the thickness of the removed stratum corneum (SC) and to determine the intact membrane thickness. Following tape-stripping, the drug is extracted from the tapes and assayed, e.g., by HPLC. This provides a drug concentration profile as a function of the normalized position within the SC. The data are fitted to a solution of Fick’s second law of diffusion in order to calculate characteristic membrane transport parameters. Integration of the concentration profile over the entire SC thickness, that is, the ‘area-under-the-curve’, provides a measure of the cutaneous bioavailability and hence can be used to assess the bioequivalence of topically applied drugs.

Keywords:
Topical bioavailability, Bioequivalence, Stratum corneum, Transepidermal water loss
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© 2001 S. Karger AG, Basel
2001
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