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Updated: Jan 29, 2026

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制药热挤出过程的流程优化:通过SIFT-MS实时检测挥发物,并与多变量分析相结合
Aaron D Smith1, Ecaterina Bordos1, Michael Devlin1
1CMAC, University of Strathclyde, Technology and Innovation Centre, Glasgow, United Kingdom; Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
International journal of pharmaceutics
|January 27, 2026
概括
选择性离子流管质谱学 (SIFT-MS) 精确地定义了用于热挤出 (HME) 的制药聚合物加工窗口. 这种方法可以检测早期的化学变化,从而实现优化无形固体分散制造.
科学领域:
- 制药科学 制药科学
- 聚合物化学 聚合物化学
- 工艺工程是过程工程.
背景情况:
- 热挤出 (HME) 对于无形固体分散 (ASD) 制造至关重要.
- 在HME过程中为制药聚合物建立强大的加工窗口是具有挑战性的,因为传统热分析的局限性.
- 在HME过程中聚合物的早期化学变化通常无法通过标准方法检测到.
研究的目的:
- 使用选择性离子流管质谱法 (SIFT-MS) 来实时描述聚合物加工过程中的挥发性演变.
- 建立数据驱动的方法来定义药物聚合物中显著化学变化的开始.
- 确定HME精确的,聚合物特定的加工窗口,以增强ASD制造.
主要方法:
- 使用精选离子流管质谱法 (SIFT-MS) 与主要成分分析 (PCA) 相结合.
- 在热重力测量分析 (TGA) 和HME条件下监测实时波动性演变.
- 中心距离映射和PCA负载被用来识别不同的热过渡和化学变化.
主要成果:
- 在四种聚合物中,SIFT-MS和PCA成功地确定了明显的过渡,表明温度驱动的化学进化的开始:Soluplus®,AffinisolTM15LV,Kollidon® VA64和PlasdoneTM S630 Ultra.
- 具体的加工窗口被定义为:Soluplus®和PlasdoneTM S630 Ultra (150-170°C),Kollidon® VA64 (160-180°C) 和AffinisolTM15LV (170-185°C).这些窗口可以分为两种.
- 这些化学定义的极限,得到了风湿学数据的支持,比制造商提供的范围更窄,更精确.
结论:
- 在传统的热分析之前,SIFT-MS提供了一种快速的,非破坏性的方法来检测HME期间聚合物中微妙的,早期的化学变化.
- 这种技术可以精确地定义聚合物特定的挤出窗口,改善ASD的过程理解和优化.
- 这些发现促进了无形固体分散物的更强大和更有效的制造.
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