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Surface Characterization of Skin Substitute Materials.

Alexander Jaekel1, Michaela Wirtz1

  • 1Department of Natural Sciences, University of applied Sciences Bonn-Rhein-Sieg, Rheinbach, Germany.

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PubMed
Summary

Developing reliable skin substitutes is crucial for transdermal drug delivery adhesion testing. This study evaluates materials like gelatine and VitroSkin, finding they offer comparable surface functionality but require further mechanical property enhancement.

Keywords:
CutometerIR spectroscopyin vitromicroscopyroughnessskin substituteskin surface

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Area of Science:

  • Materials Science
  • Biomedical Engineering
  • Pharmaceutical Sciences

Background:

  • Transdermal therapeutic systems require robust skin adhesion for reliable active pharmaceutical ingredient delivery.
  • Current in vitro adhesion testing methods using steel lack correlation with in vivo performance, necessitating improved skin substitutes.
  • Extensive in vivo studies are often required due to poor in vitro-in vivo correlation, increasing product development costs and time.

Purpose of the Study:

  • To evaluate and compare the skin-like properties of various synthetic materials for in vitro adhesion testing.
  • To establish a comprehensive Skin Similarity Index for assessing the suitability of skin substitutes.
  • To provide a baseline for developing advanced skin substitutes for transdermal adhesion assessment.

Main Methods:

  • Utilized synthetic leather, silicone (Dragon Skin), gelatines, and VitroSkin as skin substitute materials.
  • Employed reflected light microscopy and confocal light microscopy for topographical analysis.
  • Applied infrared spectroscopy for functional group analysis, and dermatological probes for friction, pH, and elasticity measurements, coupled with data fusion.

Main Results:

  • All tested substitute materials exhibited common topographic characteristics with human skin but had limitations.
  • Gelatine and VitroSkin demonstrated comparable surface functionality to human skin.
  • Significant deficits were observed in the mechanical properties of all tested substitute materials.

Conclusions:

  • A comprehensive evaluation of topography, chemical functionality, and mechanical properties revealed varying degrees of skin similarity in substitutes.
  • The developed Skin Similarity Index offers a versatile approach for evaluating skin substitutes.
  • Further research incorporating additional characteristics and materials is recommended to enhance the utility of skin substitutes in adhesion testing.