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使用过程分析技术工具,通过流化床颗粒制造的无形固体分散物中阿姆洛迪平酸酸盐含量的量化

Sandi Svetič^1,2, Laura Medved¹, Klemen Korasa^1,2

¹KRKA, d. d., 8501 Novo Mesto, Slovenia.

|January 8, 2025

概括

本研究介绍了拉曼和近红外 (NIR) 光谱方法,用于在使用流化床颗粒剂 (FBG) 的无形固体分散 (ASD) 制备过程中量化活性药物成分 (API) 含量. 这些过程分析技术 (PAT) 工具可以实时监控和控制以提高质量.

科学领域:

制药技术制药技术制药技术
过程分析技术 (PAT) 是一种分析技术.
频谱学是一种光谱学.

背景情况:

活性药物成分 (API) 含量是无形固体分散 (ASD) 中的关键质量属性 (CQA).
ASD的制备包括在流体床颗粒器中将API-聚合物溶液喷到辅助剂上.
精确量化API含量对于工艺控制和产品质量至关重要.

研究的目的:

开发和评估用于ASD制备的流化床颗粒化 (FBG) 过程中量化API含量的光谱方法.
评估拉曼和近红外 (NIR) 过程分析仪对实时监控的适用性.
调查部分最小方程 (PLS) 建模用于API量化的应用.

主要方法:

使用了拉曼和三个近红外 (NIR) 过程分析仪.
开发了四个部分最小平方 (PLS) 模型,使用来自多个颗粒批次的数据.
使用RMSEP,RMSECV和RPD等指标评估模型性能.

主要成果:

线下和线上NIR模型证明了其适用于过程控制.
在线拉曼测量准确地预测了喷阶段的终点.
PLS模型显示了API内容的良好可预测性.

结论:

这是第一个使用PAT工具在FBG期间监测API含量以准备ASD的研究.
拉曼和NIR光谱与PLS建模相结合,为监测和控制ASD制造提供了新的见解.
开发的方法支持实时质量评估和流程优化.

关键词:

拉曼光谱法拉曼光谱法无形固体分散的无形固体分散流体化床颗粒化液体化床颗粒化多变量分析多变量分析.接近红外光谱学近红外光谱学过程分析技术技术分析

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