Surface Characterization of Skin Substitute Materials.

Background: Transdermal therapeutic systems use substance transport through the skin to provide an active pharmaceutical ingredient. To ensure a reliable supply, adhesion to skin must be guaranteed. In practice in vivo studies as well as in vitro studies on steel (ISO-standard for self-adhesive tapes) are used. As in vitro-in vivo correlation is poor, extensive in vivo studies are applied during industrial product performance tests. Hence, a specialized skin substitute material for in vitro adhesion testing is needed.

Materials and methods: Synthetic leather (polyurethane), silicone (Dragon Skin), gelatines, and VitroSkin are used as skin substitute materials. For topographical analysis, reflected light microscopy and confocal light microscopy are applied. Infrared spectroscopy is performed for analysis of functional groups. Dermatological skin probe systems are used to analyze friction, surface pH, and elasticity. To bundle all data with regards to skin similarity, mid-level data fusion is applied.

Results: For all substitute materials, common topographic characteristics compared to human skin can be observed. However, all materials show limitations regarding their topography. Gelatine and VitroSkin feature comparable surface functionality compared to human skin. All materials show significant deficits in their mechanical properties. All characteristics can be summarized as the Skin Similarity Index to give a comprehensive overview regarding substitutes similarity to skin.

Conclusions: A comprehensive evaluation of topography, chemical functionality, and mechanical properties regarding a skin substitutes similarity to human skin was performed. This data should be considered as a baseline for further research in the field of adhesion to skin. By adding further characteristics and materials, it is a versatile approach that can be implemented in a variety of areas.