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In Vitro Testing of Sunscreens for Dermal Absorption: Method Comparison and Rank Order Correlation with In Vivo
Yang Yang1, Ann-Marie Ako-Adounvo2, Jiang Wang2
1Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA. Yang.Yang@fda.hhs.gov.
A reliable in vitro permeation test (IVPT) accurately predicts sunscreen UV filter dermal absorption. A single finite dose with heat-separated human epidermis best correlated with in vivo absorption data.
Area of Science:
- Dermal toxicology
- Cosmetic science
- Pharmacokinetics
Background:
- Evaluating sunscreen UV filter dermal absorption is crucial for safety assessments.
- In vitro permeation tests (IVPT) are needed to predict in vivo skin absorption.
- Existing IVPT methods require validation for bio-predictability.
Purpose of the Study:
- To compare two IVPT methods for evaluating dermal absorption of UV filters.
- To correlate in vitro absorption data with in vivo absorption data.
- To identify the most bio-predictable IVPT method for sunscreen UV filters.
Main Methods:
- Compared single finite dose vs. infinite dose application in IVPT.
- Compared heat-separated human epidermis vs. dermatomed skin models.
- Evaluated dermal absorption of six UV filters in commercial sunscreens using IVPT and in vivo studies.
Main Results:
- Both in vivo and in vitro studies showed UV filter absorption after single application.
- The IVPT method using a single finite dose and heat-separated human epidermis correlated well with in vivo clinical data.
- Rank orders for cumulative in vitro skin permeation and in vivo AUC were comparable for several UV filters (oxybenzone, homosalate, octisalate, octinoxate).
Conclusions:
- The validated IVPT method using a single finite dose and heat-separated human epidermis provides bio-predictable results for sunscreen UV filter dermal absorption.
- This method can be used to rank UV filters based on their absorption potential.
- Further optimization of IVPT parameters may improve predictions for UV filters with low skin permeation.
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