在线监测平板电脑压缩与太赫兹时域光谱测量物理平板电脑特征
Moritz Anuschek1, Thomas Kvistgaard Vilhelmsen2, J Axel Zeitler3
1Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk A/S, CMC Oral Product Development, Måløv, Denmark.
International journal of pharmaceutics
|October 16, 2025
概括
太赫兹时域光谱学 (THz-TDS) 在制造过程中提供精确,快速的平板电脑物理性能在线监测. 这一进步支持药品生产中的稳健的工艺设计和实时质量控制.
科学领域:
- 制药制造科学 制药制造科学
- 过程分析技术 (PAT) 是一种分析技术.
- 药物输送系统是药物输送系统.
背景情况:
- 工艺分析仪在制药PAT中对于稳健的工艺设计和连续制造至关重要.
- 现有的传感器主要集中在化学成分上,对监测平板电脑物理性能的选择有限.
研究的目的:
- 为了报告和对比特拉赫兹时域光谱 (THz-TDS) 在实验室尺度压缩过程中对平板电脑物理性质进行直线监测.
- 评估THz-TDS在平板电脑制造中的校准,直线应用和好处.
主要方法:
- 利用THz-TDS进行实验室规模的平板电脑压缩过程中的物理性质在线监测.
- 将THz-TDS性能与用于平板电脑属性分析的现有传感器进行比较.
主要成果:
- THz-TDS实现了对安慰剂片的厚度,质量,多孔性,破裂力和分解时间的准确监测.
- 对于所有测量的属性,获得了低根平均平方预测误差 (RMSEP),平均测量速度为每片1.5秒.
结论:
- THz-TDS提供了一种可行的实时监测关键物理平板电脑性能的可行方法.
- 未来的实施可以增强过程理解,实现实时控制,并支持实时发布测试.
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