在线孔隙传感器用于立即释放片中的非破坏性分解测试
Prince Bawuah1, Mike Evans2, Ard Lura3
1University of Cambridge, Department of Chemical Engineering and Biotechnology, UK.
International journal of pharmaceutics: X
|July 3, 2023
概括
自动化太赫兹光谱仪提供快速,非破坏性的平板电脑孔径测量. 这种技术将毛孔度与分解时间关联起来,有助于制药质量控制.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 频谱学是一种光谱学.
背景情况:
- 平板电脑的多孔性是影响药物释放和生物可用性的关键质量属性.
- 传统的孔径测量方法往往具有破坏性和耗时性.
- 开发快速,非破坏性的技术对于高效的制药制造和质量控制至关重要.
研究的目的:
- 评估在线太赫兹时域光谱 (THz-TDS) 对测量平板电脑孔隙性的实用性.
- 为了研究制造参数 (炮塔速度,压缩压力) 对平板电脑孔隙性的影响.
- 建立一个预测模型,将平板电脑孔隙与分解时间相关联.
主要方法:
- 在传输模式中使用全自动在线太赫兹时域光谱 (THz-TDS).
- 准备并分析了六批1000片即时释放片,每批1000片,不同的炮塔速度和压缩压力.
- 执行了用于模型开发的破坏性解体时间测量.
主要成果:
- THz-TDS提供了精确的,非破坏性的测量板块折射率和多孔度.
- 制造参数显著影响了药片的多孔度,平均多孔度从5.5%到26.5%不等.
- 基于孔隙性的分解时间开发了一个合理的预测模型.
- 经过9个月的环境储存后,平板电脑的性能发生了变化.
结论:
- 自动化THz-TDS是一种可行的工具,用于快速,非破坏性的在线监测药品制造中的平板电脑孔隙.
- 了解制造参数,多孔度和分解时间之间的关系对于药片质量至关重要.
- THz-TDS可以随着时间的推移检测平板电脑特性变化,支持长期稳定性评估.
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