Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products

摘要

The increasing offering of patch-based medical devices is accompanied by growing numbers of reported adverse skin reactions. Procedures for testing leachables according to ISO 10993 may not be optimal for lipophilic substances that can be mobilized on skin by sweat and sebum. We propose an improved extraction method for targeted analysis of leachables using low volumes of a sweat-sebum emulsion. The approach is illustrated by the analysis of isobornylacrylate (IBOA), a compound found in some devices and suspected for allergenic potential.