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垂直热挤出:创新的下一个挑战

Maël Gallas^1,2, Ghouti Medjahdi², Pascal Boulet²

¹Rondol Industrie, 2 Allée André Guinier, 54000 Nancy Cedex, France.

|July 30, 2025

概括

垂直热挤出 (HME) 成功创造了稳定的无形固体分散,提高了药物溶解度和受控释放. 这种创新的HME技术为制药制造提供了一个紧而高效的平台.

科学领域:

制药科学制药科学
材料科学材料科学材料科学

背景情况:

热挤出 (HME) 对于改善难以溶解的活性药物成分 (API) 的溶性至关重要.
纵向HME虽然比水平HME更少被探索,但在节省空间,食,温度管理和连续制造集成方面具有优势.
本研究探讨了用于优化药物聚合物相互作用的垂直HME,并创建可控释放的稳定无形分散.

研究的目的:

研究用于制药配方的垂直热挤出 (HME).
优化药物聚合物相互作用,以获得稳定的无形分散.
使用垂直HME开发可控药物释放配置文件.

主要方法:

使用一个垂直热挤出机 (Rondol Industrie).
使用乙撒利酸 (ASA) 作为Soluplus®和Kollidon® 12 PF聚合物的模型API.
使用粉末X射线衍射 (PXRD) 和小角度X射线散射 (SAXS) 进行特征化挤出.
通过USP Apparatus II溶解测试进行体外药物释放的评估.

主要成果:

垂直的HME产生了均的无形固体分散.
PXRD证实没有结晶性;SAXS表示药物负载和热输入影响了聚合物纳米结构.
在体外溶解试验显示,与晶体形式相比,ASA释放率显著提高,具有高可重现性.

结论:

垂直HME是一种可行的,紧的模块化技术,用于开发稳定的无形分散.
这种方法有助于控制药物释放和制药创新.
垂直HME显示了具有成本效益的连续制造和工业扩展的潜力.

关键词:

无形固体分散的分散.生物可用性生物可用性药物输送系统是药物输送系统.挤出加工参数挤出加工参数溶解度溶解度溶解度溶解度垂直的热挤出方式

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