In vivo stratum corneum distribution of lidocaine, assessed by tape stripping, from a new bioadhesive film.

摘要

BACKGROUND/PURPOSE: The aim of this work was to study the in vivo performance of an innovative drug-delivery system, denominated Patch-non-Patch, using the tape-stripping technique. METHODS: The stratum corneum distribution of lidocaine, chosen as the model drug, was studied on human volunteers, using the tape-stripping technique. The amount of lidocaine recovered in tape strips was quantified using high-pressure liquid chromatography. RESULTS: When lidocaine was included in the film, the model drug was found in the stratum corneum already after 5 min of contact time. The increase in the application time increased lidocaine recovery in the stratum corneum, although only the extreme application times (5-10 min and 24 h) were significantly different. The profile of lidocaine recovered in the stratum corneum from the film was comparable with that obtained from the equivalent water solution, confirming the conclusion of in vitro permeation data that the film does not reduce lidocaine mobility inside the film and its partitioning into the stratum corneum. CONCLUSION: The bioadhesive film studied in this work seems to be an effective system for the delivery of drugs to the skin.