Assessment of drug permeability distributions in two different model skins
Assessment of drug permeability distributions in two different model skins
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DOI：
10.1016/j.ijpharm.2005.07.005
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发表时间：
2005-10-13
影响因子：
5.8
通讯作者：
Meidan, VM
中科院分区：
文献类型：
--
作者：
Khan, GM;Frum, Y;Meidan, VM
过去对人体皮肤的体外研究表明，药物渗透系数（K-p）分布并不总是遵循高斯正态模式。这具有重要的统计学意义，例如，使用t检验来评估显著性仅限于正态分布的人群。经皮吸收研究通常涉及使用动物或合成皮肤来模拟不太容易获得的人体皮肤。然而，在评估这些模型膜的渗透性变化方面所做的工作可以忽略不计。本文旨在填补这一空白。为此，进行了四项研究，代表两种不同的药物（咖啡因和睾酮），每种药物穿透两种不同的模型皮肤（硅胶膜和猪皮）。结果表明，在有机硅膜研究中，两种化合物的K-p分布都符合正常模式。相比之下，在猪皮研究中，每种药物之间存在显着差异。虽然睾酮的K-p值可以符合正态分布，但咖啡因的K-p数据不可能符合正态分布，它可以符合对数正态分布。从文献和物理化学角度来看，这些结果可能反映了依赖于膜和渗透特性的总体趋势。(c) 2005 Elsevier B.V.版权所有
Past in vitro studies with human skin have indicated that drug permeability coefficient (K-p) distributions do not always follow a Gaussian-normal pattern. This has major statistical implications, exemplified by the fact that use of t-tests to evaluate significance is limited to normally distributed populations. Percutaneous absorption research often involves using animal or synthetic skins to simulate less readily available human skin. However, negligible work has been performed on assessing the permeability variabilities of these model membranes. This paper aims to fill this gap. To this end, four studies were undertaken representing two different drugs (caffeine and testosterone) with each drug penetrating through two different model skins (silicone membrane and pig skin). It was determined that in the silicone membrane studies, both compounds' K-p distributions could be fitted to a normal pattern. In contrast, in the pig skin studies, there were notable differences between each drug. While the testosterone K-p values could be fitted to a normal distribution, this was not possible with the caffeine K-p data, which could be fitted to a log-normal distribution. There is some evidence from the literature as well as physicochemical considerations that these outcomes may reflect general trends that are dependent upon both membrane and penetrant properties. (c) 2005 Elsevier B.V. All rights reserved.