通过使用PAT工具的流化床颗粒制造的无形固体分散物中量化阿姆洛迪平酸盐的结晶性
Sandi Svetič1, Laura Medved2, Franc Vrečer3
1Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia; KRKA, d. d., 8501 Novo Mesto, Slovenia.
概括
这项研究开发了拉曼和NIR光谱法,用于在无形固体分散 (ASD) 中量化晶体氨基氨酸酸. 这些过程分析技术 (PAT) 工具通过检测不需要的结晶来确保ASD的物理稳定性.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 工艺工程是过程工程.
背景情况:
- 无形固体分散 (ASD) 的物理稳定性对于药物产品的性能至关重要.
- 在ASD中,残留结晶性可以充当核化部位,从而损害长期稳定性.
- 有效监测ASD制造对于防止结晶至关重要.
研究的目的:
- 开发和验证用于ASDs中的晶体氨基氨酸酸的定量方法.
- 在ASD制造过程中应用拉曼和近红外 (NIR) 光谱技术进行线内工艺监测.
- 通过结晶检测来评估ASD配方的物理稳定性.
主要方法:
- 使用拉曼和NIR光谱学的四个定量模型的开发.
- 使用部分最小方程 (PLS) 回归用于模型构建.
- 作为ASD制剂的制造工艺,采用流化床颗粒化.
- 使用诸如根平均平方预测误差 (RMSEP) 和剩余预测偏差 (RPD) 等指标的模型验证.
主要成果:
- 证明了氨基酸的无形和晶体形式之间的明显光谱差异.
- 成功开发了四个具有不同数据集大小的PLS模型进行量化.
- 在ASD中实现了结晶性 amlodipine maleate含量的可靠预测.
- 确定了晶体杂质的检测极限.
结论:
- 拉曼和NIR光谱与PLS相结合,是监测流化床颗粒化过程中ASD结晶的有效工具.
- 这项研究为ASD制造提供了工艺分析技术 (PAT) 的新应用.
- 开发的方法有助于确保ASD配方的物理稳定性和质量.
相关概念视频
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