Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ 08855, USA; Center for Dermal Research, Life Sciences Building, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA.
EMD Millipore Corporation, 17 Cherry Hill Drive, Danvers, MA 01923, USA.
Int J Pharm. 2018 Aug 25;547(1-2):432-437. doi: 10.1016/j.ijpharm.2018.06.012. Epub 2018 Jun 14.
The aim of this work was to investigate the correlation of permeation behavior of transdermal formulations through a novel synthetic membrane (Strat-M® EMD Millipore, MA) and human cadaver skin. Strat-M® membranes were designed with the intent to share similar structural and chemical characteristics found in the human skin however, omitting any biological behavior due to the absence of viable cells. Both human skin and the membrane display a layered structure with a very tight top layer. Additionally, the Strat-M® membrane contains a combination of lipids in a specific ratio similar to what is found in the human stratum corneum (SC). Formulations containing nicotine and a chemical penetration enhancer (CPE) were used for evaluating drug penetration to understand how each enhancer impacts the permeability of nicotine as a model compound. The permeability measurements of human cadaver skin and Strat-M® membrane were performed with Franz diffusion cell methods accompanied by HPLC analysis. A good correlation of the permeability data was obtained through human cadaver skin and Strat-M® membrane. Thus, Strat-M® has the potential to be used as a screening tool for evaluating topical/transdermal formulations through the human cadaver skin.
本工作旨在研究经皮制剂通过新型合成膜(Strat-M® EMD Millipore,MA)和人体尸体皮肤的渗透行为的相关性。Strat-M® 膜的设计意图是具有与人皮肤相似的结构和化学特征,但由于缺乏活细胞而不具有任何生物学行为。人体皮肤和膜都显示出分层结构,最顶层非常紧密。此外,Strat-M®膜包含特定比例的组合脂质,类似于人角质层(SC)中发现的脂质。含有尼古丁和化学渗透增强剂(CPE)的制剂用于评估药物渗透,以了解每种增强剂如何影响尼古丁作为模型化合物的渗透性。Franz 扩散池法结合 HPLC 分析进行了人体尸体皮肤和 Strat-M®膜的渗透测量。通过人体尸体皮肤和 Strat-M®膜获得了良好的渗透性数据相关性。因此,Strat-M®有可能被用作通过人体尸体皮肤评估局部/经皮制剂的筛选工具。