Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
J Invest Dermatol. 2020 Dec;140(12):2487-2495. doi: 10.1016/j.jid.2020.04.009. Epub 2020 Apr 28.
Sunscreen products contain UV filters as active ingredients for the protection of the skin against UVR. The US Food and Drug Administration (FDA) issued a new proposed rule in 2019 (84.FR.6204) for sunscreens and identified the need for additional safety data for certain UV filters including their dermal absorption data. Dermal absorption data reveal systemic exposure of UV filters in humans, which can be obtained from clinical maximal usage trials. FDA guidance recommends conducting in vitro skin permeation tests (IVPTs) to help select formulations for maximal usage clinical trials as IVPT results may be indicative of in vivo absorption. This case study reports in vitro methodologies used for the selection of sunscreen products for an FDA-sponsored proof-of-concept maximal usage clinical trial. An IVPT method was developed using human cadaver skin. Commercially available sunscreen products were tested to determine the skin absorption potential of common UV filters using the IVPT. All the studied sunscreen products demonstrated a certain degree of skin absorption of UV filters using IVPT, and a formulation rank order was obtained. These sunscreen products were also characterized for several formulation properties including the globule size in emulsions, which was found to be an indicator for the rank order.
防晒霜产品含有紫外线过滤剂作为活性成分，用于保护皮肤免受 UVR 的伤害。美国食品和药物管理局（FDA）在 2019 年发布了一项新的防晒产品拟议规则（84.FR.6204），并确定需要对某些紫外线过滤剂（包括其皮肤吸收数据）进行额外的安全数据。皮肤吸收数据揭示了人类对紫外线过滤剂的全身暴露情况，这些数据可以从临床最大使用试验中获得。FDA 指南建议进行体外皮肤渗透试验（IVPT），以帮助选择最大使用临床试验的配方，因为 IVPT 结果可能表明体内吸收情况。本案例研究报告了用于选择 FDA 赞助的概念验证最大使用临床试验的防晒霜产品的体外方法学。使用人体尸体皮肤开发了一种 IVPT 方法。对市售的防晒霜产品进行了测试，以使用 IVPT 确定常见紫外线过滤剂的皮肤吸收潜力。所有研究的防晒霜产品都通过 IVPT 显示出一定程度的紫外线过滤剂皮肤吸收，并且获得了配方等级顺序。还对这些防晒霜产品进行了几种配方特性的表征，包括乳液中的液滴大小，发现其是等级顺序的指示符。
