Application of an Optimized Tape Stripping Method for the Bioequivalence Assessment of Topical Acyclovir Creams

AAPS PharmSciTech
Sumalatha NallagundlaIsadore Kanfer

Abstract

This study indicates the application of tape stripping (TS) for bioequivalence (BE) assessment of a topical cream product containing 5% acyclovir. A TS method, previously used successfully to assess BE of topical clobetasol propionate and clotrimazole formulations, was used to assess BE of an acyclovir cream (5%) formulation as well as a diluted acyclovir formulation (1.5%) applied to the skin of healthy humans. An appropriate application time was established by conducting a dose duration study using the innovator product, Zovirax® cream. Transepidermal water loss was measured and used to normalize thicknesses between subjects. The area under the curve (AUC) from a plot of amount of acyclovir/strip vs cumulative fraction of stratum corneum (SC) removed was calculated for each application site. BE was assessed using Fieller's theorem in accordance with FDA's guidance for assessment of BE of topical corticosteroids. Adco-acyclovir cream (5%) was found to be BE to Zovirax® cream, where the mean test/reference (T/R) ratio of the AUC's was 0.96 and the bioequivalence interval using a 90% confidence interval was 0.91-1.01 with a statistical power > 95%, whereas the diluted test product fell outside the BE acceptance criteria with T/R...Continue Reading

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Citations

Oct 31, 2018·Clinical Pharmacology and Therapeutics·Corinne Seng YueMurray P Ducharme
Jan 23, 2021·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Lili WuChunquan Sheng

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Methods Mentioned

BETA
Assay

Software Mentioned

GraphPad Prism
EquivTest

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