Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products.

ABSTRACT:

Purpose

To examine the potential of stratum corneum (SC) sampling via tape-stripping in humans to assess bioequivalence of topical acyclovir drug products, and to explore the potential value of alternative metrics of local skin bioavailability calculable from SC sampling experiments.

Methods

Three acyclovir creams were considered in two separate studies in which drug amounts in the SC after uptake and clearance periods were measured and used to assess bioequivalence. In each study, a "reference" formulation (evaluated twice) was compared to the "test" in 10 subjects. Each application site was replicated to achieve greater statistical power with fewer volunteers.

Results

SC sampling revealed similarities and differences between products consistent with results from oth

SUBMITTER: Pensado A 

PROVIDER: S-EPMC6856025 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature