Abstract # A-35

Skin Absorption Methodology: Improving The Lipophilicity Of The Receptor Fluid And The Accuracy Of The Skin Viability Assay. H. L. Hood, M. G. Robl, and R. L. Bronaugh. FDA, CFSAN, Laurel, MD.

The receptor fluid used in an in vitro percutaneous absorption study should not only serve as a receptor for the penetrant but also preserve the viability of the skin. Lipophilicity of the receptor fluid plays a crucial role in facilitating the release of a lipophilic compound from skin into the receptor fluid. Until now, 4% bovine serum albumin (BSA) has routinely been added to HEPES-buffered Hanksł balanced salt solution (HHBSS) to increase the aqueous solubility of lipoidal compounds. Hydroxypropyl-ß-cyclodextrin (HPCD) was compared with BSA for its ability to solubilize lipid material and also maintain skin viability. Concurrent with the development of a more lipophilic receptor fluid, a second skin viability assay was evaluated as an alternative test to the lactate assay. Ultimately, the MTT (3-{4,5-dimethylthiazol-2-yl}-2,5-diphenyltetrazolium bromide) assay was shown to be a more accurate and reliable method for assessing skin viability than the lactate assay. HHBSS + 2% HPCD proved to be more suitable than HHBSS + 4% BSA. With HHBSS + 2% HPCD, better agreement was found between the results of in vitro and in vivo skin absorption studies of a fragrance ingredient and skin viability was maintained for the entire 24-hr study.