使用重建的人体皮肤与人类尸体皮肤模型进行防晒的体外透测试
Kartik R Roy1, Apipa Wanasathop1,2, Lijing Xu1
1Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.
AAPS PharmSciTech
|February 10, 2026
概括
重建的人体皮肤 (RHS) 为体外透测试 (IVPT) 提供了可靠的替代方案. EpiDermFT (带皮层的RHS) 提供了与人类尸体皮肤 (HCS) 相比的一致结果.
科学领域:
- 皮肤药物递送和配方科学.
- 生物材料和组织工程.
- 药理动力学和药物代谢.
背景情况:
- 试验室透测试 (IVPT) 对于局部产品开发和监管评估至关重要.
- 切除的人体皮肤 (EHS) 和人体尸体皮肤 (HCS) 是IVPT中常见的扩散障碍.
- 有限的EHS供应和HCS捐赠者的变异性对一致的IVPT结果构成挑战.
研究的目的:
- 评估重建的人体皮肤 (RHS) 作为IVPT的可行的替代扩散屏障.
- 通过HCS和RHS模型比较防晒的透度.
- 评估不同RHS模型的一致性和灵敏性.
主要方法:
- 通过两个人体尸体皮肤 (HCS) 模型和两个重建的人体皮肤 (RHS) 模型 (EpiDermFT和EpiDerm) 进行防晒透的比较.
- 评估批量内和批量间透的一致性.
- 对配方pH值变化的敏感度的评估.
主要成果:
- EpiDermFT (带皮层的RHS) 显示出一致的批量内和批量间透结果.
- 与HCS相比,EpiDermFT的累积透率呈现出类似的排名顺序.
- EpiDerm (没有皮肤层的RHS) 对配方pH的变化表现出比HCS更高的灵敏度.
结论:
- 在IVPT中,EpiDermFT显示出作为HCS可靠替代品的潜力,提供可比的透数据.
- EpiDerm可以作为一种敏感的工具来检测局部产品中的配方pH差异.
- 需要进一步研究各种配方和剂型,以确定RHS在IVPT中的广泛适用性.
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