湿颗粒工艺变量的对传输量测试模型的影响 药品片的拉曼光谱
Ryo Ohashi1, Tatsuo Koide2, Toshiro Fukami3
1Department of Molecular Pharmaceutics, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588 Japan; Formulation R&D Laboratory, R&D Division, SHIONOGI & CO., LTD., Hyogo 660-0813, Japan.
概括
传输拉曼光谱 (TRS) 是一种强大的工具,用于在片中进行非破坏性药物含量分析. 即使在湿颗粒过程中存在差异,TRS模型也能准确预测药物度,证明了其在制药生产中的多功能性.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 传输拉曼光谱 (TRS) 是一种非破坏性分析工具,用于评估药物含量.
- 大多数现有的TRS研究集中在直接压缩的片中,使湿颗粒对模型性能的影响在很大程度上未被探索.
研究的目的:
- 调查上游工艺变化的影响,特别是在湿颗粒过程中,对TRS定量模型对药物含量在片中的预测准确性的影响.
主要方法:
- 开发部分最小平方 (PLS) 校准模型,用于1%w/w药片中的药物度 (70-130%标签声明).
- 用不同的粒度参数 (尺度,厚度) 制造的片剂中药物含量的预测.
主要成果:
- 颗粒化参数的变化导致预测药物恢复的实际可接受偏差.
- 开发的TRS校准模型在不同的颗粒量表和平板厚度上表现出强大的预测性能.
结论:
- 对于上游颗粒处理过程和下游平板制剂参数的变化,TRS定量模型表现出强度.
- 传输拉曼光谱是一种多功能,非破坏性的方法,适用于在整个药片制造过程中进行定量分析.
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