Collection of Sample

Skin-stripping proceeds first with the removal of the first one to two layers of stratum corneum with two adhesive tapes strip/disc applications, using a commercially available product (e.g., D-Squame, Transpore). These first two tape strip(s) contain the generally unabsorbed, as opposed to penetrated or absorbed, drug, and therefore should be analyzed separately from the rest of the tape-strips. The remaining stratum corneum layers from each site are stripped at the designated time intervals. This is achieved by stripping the site with an additional 10 adhesive tape strips. All 10 tape strips obtained from a given time point are combined and extracted, with drug content determined using a validated analytical method. The values are generally expressed as amounts/area (e.g., ng/cm) to maintain uniformity in reported values. Data may be computed to obtain full drug concentration-time profiles, Cmax-ss, Tmax-ss, and AUCs for the test and reference products.

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