从光学孔隙度测量中预测体外溶解和药片硬度
Stephan Sacher1, Andreas Kottlan1, Jean-Baptiste Diop2
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2 8010, Graz, Austria.
International journal of pharmaceutics
|June 13, 2024
概括
先进的制造需要快速的质量检查. 这项研究使用光学孔隙性,一种非破坏性方法预测平板电脑的硬度和药物释放,支持实时释放测试.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 连续制造需要快速评估药品的质量.
- 当前的过程分析技术 (PAT) 不能测量所有关键质量属性 (CQA),如平板硬度和体外溶解,这需要破坏性离线测试.
- 溶解测试是特别耗时和劳动密集的.
研究的目的:
- 用光学孔隙度测量来预测药片的关键质量属性 (CQAs),特别是体外溶解和药片硬度.
- 评估在连续平板制造过程中使用光学多孔度作为PAT工具的可行性.
- 探索光学多孔性的潜力,以支持实时释放测试 (RTRT) 策略.
主要方法:
- 用SpectraPore仪器测量了平板电脑的光学孔隙性,使用一种新的气体在散射介质吸收光谱 (GASMAS) 和飞行光谱的光子时间 (pTOFS) 的组合.
- 开发的方法在连续片剂生产线上实施和测试.
- 建立了光学孔隙度和CQA (溶解,硬度) 之间的相关性.
主要成果:
- 该研究在预测特定溶解时间释放的药物量方面显示出有希望的结果.
- 通过光学孔隙度测量,可以准确预测平板硬度.
- 光学孔隙度测量技术显示了集成到连续制造中的潜力.
结论:
- 使用GASMAS和pTOFS进行光学孔隙度测量,可以作为一个可行的PAT工具来预测关键平板电脑CQAs.
- 这种方法可以减少需要耗时的离线测试的需求,例如溶解.
- 光学孔径的测量支持实时释放测试 (RTRT) 在制药连续制造中的实施.
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