通过共聚焦拉曼光谱 (CRS) 进行的关键皮肤内生物等价性研究
J Link1, C Heusel1, D J Lunter1
1Department of Pharmaceutical Technology and Biopharmacy, University of Tuebingen, Tuebingen, Germany.
概括
与Tape Stripping (TS) 相比,对焦拉曼光谱法 (CRS) 为皮肤生物等价性研究提供了一种优越的非侵入性方法. 这项研究验证了CRS用于评估局部产品的生物等价性,符合EMA指南.
科学领域:
- 皮肤病学和制药科学 皮肤病学和制药科学
- 非侵入性的 in-vivo生物等价性评估.
- 局部药物输送和药理动力学
背景情况:
- 关于皮肤产品的EMA指导方针偏好皮层角膜 (SC) 取样 (带剥离,TS) 而不是临床研究.
- 像Confocal Raman Spectroscopy (CRS) 这样的替代方法尚未获得批准,但具有优势.
- 之前的工作表明了TS和CRS结果之间的相关性.
研究的目的:
- 证明非侵入性CRS对皮肤生物等价性评估的适用性.
- 为建立CRS作为标准方法提供关键数据.
- 用酸配方验证CRS并与EMA生物等价性要求进行比较.
主要方法:
- 一项体内实验研究,涉及12名健康志愿者和四种酸配方 (参考,试验,对照).
- 非侵入性CRS测量是在1小时 (吸收) 和4小时 (清除) 后产品移除后进行的.
- 使用785nm激光获得了SC透概况,深度为15μm,使用785nm激光.
主要成果:
- 该CRS方法成功地满足了所有EMA生物等价性要求.
- 测试产品的90%置信区间位于平均生物等价性 (ABE) 的80-125%接受范围之内.
- 该研究证实了使用CRS方法测试的配方的生物等价性.
结论:
- 本研究介绍了首次使用CRS进行皮肤,体内生物等价性评估,并遵循EMA指南.
- 这些关键数据证实CRS是一种适合和有利的皮肤生物等效方法.
- 这些发现支持建立CRS以获取生物等效数据和潜在的指南更新.
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