作为平板电脑质量分析仪的过程分析仪的THz-TDS转折测量
Moritz Anuschek1, Thomas Kvistgaard Vilhelmsen2, J Axel Zeitler3
1Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk A/S, ET Oral Product Development, Måløv, Denmark.
International journal of pharmaceutics
|September 26, 2024
概括
太赫兹时域光谱 (THz-TDS) 提供了一种新的快速方法来测量药片质量,这对于药品质量至关重要. 这种技术可以在制造过程中实时监测药片的重量和高度.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 频谱学是一种光谱学.
背景情况:
- 药片含量的一致性对于药物的有效性和市场上市至关重要.
- 目前用于控制平板电脑质量的方法缺乏稳定性,灵敏性和速度.
- 过程分析技术 (PAT) 对于实时制药制造控制至关重要.
研究的目的:
- 研究太赫兹时域光谱法 (THz-TDS) 作为用于测量平板电脑质量的过程分析工具.
- 评估使用THz-TDS在线监测平板电脑物理属性的可行性.
- 探索THz-TDS在平板电脑质量和高度的同时测量方面的潜力.
主要方法:
- 使用太赫兹时域光谱学 (THz-TDS) 在反射设置中分析平板电脑.
- 测量了前侧反射和后侧反射信号的时间延迟.
- 与背部转折的时间延迟与药片质量相关联.
主要成果:
- 药片质量的增加与背面转折信号的时间延迟增加直接相关.
- 取得了大约1毫克的根平均平方误差,用于测定片的质量.
- 证明了用于快速分析的高采集率 (50 Hz) 的潜力.
- 展示了使用前侧反射同时测量平板高度的方法.
结论:
- THz-TDS是间接测量平板电脑质量的可行和敏感方法.
- 该技术可以在线监测平板电脑的质量和高度,支持内容统一性的策略.
- 这种方法可以根据物理属性对平板电脑压缩过程进行实时控制.
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