在线NIR光谱用于全面了解低剂量配方连续生产中半连续混合的过程
Louis Bouckaert1, Alexander De Man2, Lisa De Souter2
1Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
International journal of pharmaceutics
|June 20, 2025
概括
近红外 (NIR) 光谱监测器在半连续制造中实现混合均性. 这个过程分析技术 (PAT) 工具提高了对混合动态的理解,确保了产品质量.
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.
- 频谱学是一种光谱学.
背景情况:
- 过程分析技术 (PAT) 对于连续制造中的质量控制至关重要.
- 在线监控工具对于实时过程评估至关重要.
研究的目的:
- 实施近红外 (NIR) 线性光谱技术,以检测混合物的一致性.
- 在半连续机中评估对流和分散混合.
- 了解工艺参数对混合性能的影响.
主要方法:
- 使用线性近红外 (NIR) 光谱学.
- 应用了局部最小方形 (PLS) 回归和移动块标准偏差 (MBSD) 来检测终点.
- 研究了一种含有2%咖啡因的二进制配方.
主要成果:
- 增加螺旋轮转速减少了对流混合时间.
- 较大的粉末体积增加了对流混合时间.
- 较高的填充水平在较低的螺旋轮转速下延长了分散混合时间.
结论:
- 实时NIR监控增强了半连续混合过程的过程理解.
- 像NIR光谱这样的PAT工具对于确保混合物均性和产品质量至关重要.
- 优化过程参数可以提高混合效率.
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