期刊
PHARMACEUTICS
卷 14, 期 7, 页码 -出版社
MDPI
DOI: 10.3390/pharmaceutics14071370
关键词
percutaneous absorption; artificial skin membrane; Fick's first law of diffusion; finite dose condition; safety assessment
A novel mathematical model was established in this study, considering the permeation parameters and water evaporation, to evaluate the potential application of parameters obtained from artificial membrane Strat-M(R) in the safety assessment of cosmetic and dermopharmaceutical products.
Estimation of the percutaneous absorption is essential for the safety assessment of cosmetic and dermopharmaceutical products. Currently, an artificial membrane, Strat-M (R), has been focused on as the tool which could obtain the permeation parameters close to the skin-derived values. Nevertheless, few practical methodologies using the permeation parameters for assessing percutaneous absorption under in-use conditions are available. In the present study, based on Fick's first law of diffusion, a novel mathematical model incorporating the permeation parameters as well as considering the water evaporation (T-eva) was constructed. Then, to evaluate the applicability domain of our model in the case where Strat-M (R)-derived parameters were used, the permeation parameters were compared between the skin from edible porcine and Strat-M (R). Regarding chemicals (-0.2 <= Log K-ow <= 2.0), their permeation profiles were equivalent between Strat-M (R) and porcine skin. Therefore, for these chemicals, the percutaneous absorption was calculated using our model with the permeation parameters obtained using Strat-M (R) and the T-eva determined by measuring the solution weight. The calculated values revealed a good correlation to the values obtained using porcine skin in finite dose experiments, suggesting that our mathematical approach with Strat-M (R) would be useful for the future safety assessment of cosmetic and dermopharmaceutical products.
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