Sunscreens are regulated by the FDA under the Over-the-Counter (OTC) monograph. Although chemical UV filters, the active ingredients in sunscreens, are intended to function on the skin surface, they have been detected in blood. Currently, the FDA recommends Maximal Usage Trials (MUsT) to demonstrate systemic exposure of chemical UV filters in sunscreens toward consideration as Generally Recognized As Safe and Effective (GRASE). Physiologically-based pharmacokinetic (PBPK) modeling may serve as a risk-based assessment tool for sunscreen formulations by predicting skin permeation for UV filters under ex-vivo conditions and while leveraging information on key formulation attributes. The purpose of this study was to predict systemic exposure of a sunscreen UV filter (oxybenzone) following sunscreen application in virtual subjects. Herein, we developed a PBPK model for oxybenzone which was able to predict pharmacokinetic endpoints upon single and repeated sunscreen applications.
Learning Objectives:
Upon completion, participants will be able to appreciate the application of PBPK modeling in predicting skin absorption for sunscreens.
Upon completion, participants will be able to understand FDA's regulations and current thinking on sunscreen quality and safety research.
Upon completion, participants will be able to understand how the PBPK modeling approach is used in drug development.
