表面活性原料的变化对HME连续制造中的挤出清晰度 (透明度) 的影响
Claudia A Lohmann1, Esther Bochmann2, Samuel O Kyeremateng2
1Waters Corporation, Milford, MA, USA.
Pharmaceutical development and technology
|July 12, 2024
概括
聚酸盐80的变化,一个关键成分,在热挤出制造过程中导致挤出物外观的变化. 控制原材料的一致性对于连续制造中产品质量的一致性至关重要.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学 材料科学 材料科学
背景情况:
- 热挤出 (HME) 是制药配方的连续制造工艺.
- 挤出外观是一个关键的质量属性.
- 配方成分包括科波维和聚酸盐80.
研究的目的:
- 在HME连续制造过程中监测和调查挤出材料外观的变化.
- 为了确定挤出剂配方中度的根本原因.
主要方法:
- 连续热挤出3天时间.
- 离线分析使用差分扫描热度计 (DSC) 和先进的聚合物染色学 (APCTM).
主要成果:
- 挤出剂的外观随着时间的推移从杂变为半透明,尽管过程参数是固定的.
- 度与80聚酸盐的分批变异性相关,特别是其低分子量成分含量 (23-27%).
- 杂的挤出材料显示玻璃过渡温度比预期高2°C.
结论:
- 原材料的批量变化,如聚酸盐80,可以显著影响连续制造中的挤出物外观.
- 确保料材料的一致质量对于强大的HME流程至关重要.
- 先进的聚合物色谱对于检测影响产品质量的微妙材料变异非常有价值.
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