ORIGINAL ARTICLE
Utilization of Reconstructed Cultured Human Skin Models as an Alternative Skin for Permeation Studies of Chemical Compounds

Satoshi Kano, Hiroaki Todo, Kenichi Sugie, Hidenori Fujimoto, Keiichi Nakada, Yoshihiro Tokudome, Fumie Hashimoto and Kenji Sugibayashi

Faculty of Pharmaceutical Sciences, Josai University, Saitama, Japan

AATEX 15(2):61-70, 2010

Two reconstructed human skin models, EpiskinSM and EpiDermTM, have been approved as alternative membranes for skin corrosive/irritation experiments due to their close correlation with animal skin. Such reconstructed human skin models were evaluated as alternative membranes for skin permeation experiments. Seven drugs with different lipophilicities and almost the same molecular weight were used as test penetrants. Relationships were investigated between permeability coefficients (P values) of the seven drugs through six kinds of reconstructed cultured human skin models and human skin. A fairly good relationship in P values was observed between TESTSKINTM LSE-high (LSE-high) or EpiDermTM and human skin, suggesting that these reconstructed human skin models could be used as alternative membranes for skin permeation experiments. However, the partition parameter, KL, and diffusion parameter, DL-2 in these reconstructed human skin models were different to those of human skin. Especially, KL values in reconstructed human skin models were very different to those in human skin, even for LSE-high and EpiDermTM. Therefore, suitable reconstructed human skin models should be carefully selected on a case by case basis.

key words: reconstructed human skin models, skin permeation, alternative membrane. skin corrosive/irritation

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(AATEX: Altern. Animal Test. EXperiment.: Alternatives to Animal Testing and EXperimentation)