高度度有机溶剂向前透用于制药前度
Ryoichi Takada1,2, Ryosuke Takagi3, Hideto Matsuyama1,3
1Department of Chemical Science and Engineering, Kobe University, Kobe 657-8501, Japan.
Membranes
|January 22, 2024
概括
这项研究引入有机溶剂前透 (OSFO) 用于缩制药成分. 新的膜工艺实现了52%的模型活性药物成分 (API) 的重量度,来自11%的重量溶液,没有泄漏.
科学领域:
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
- 分离过程 分离过程.
背景情况:
- 制药净化占该行业资本投资的一半以上.
- 目前的净化方法通常需要高能量投入,并且依赖温度,对敏感化合物构成挑战.
- 非常需要具有成本效益的非热净化技术,能够处理高度缩的溶液.
研究的目的:
- 调查高度有机溶剂前透 (OSFO) 膜工艺用于制药预度的有效性.
- 为了评估在有机溶剂环境中新型聚烯基薄膜复合材料空心纤维膜的性能.
- 为温度敏感活性药物成分 (API) 和其中间产品展示一种非热性,成本效益高的净化方法.
主要方法:
- 使用基于聚烯的薄膜复合材料空心纤维膜与聚胺选择性层.
- 采用甲醇 (MeOH) 作为溶剂,糖八酸盐 (SoA) 作为模型API,以及2M聚乙烯基醇400 (PEG-400) /MeOH溶液作为吸水溶液 (DS).
- 在室温 (23±3°C) 进行OSFO,以评估膜的性能和度能力.
主要成果:
- 成功将11%的SoA/MeOH溶液缩到52%的重量,没有任何SoA泄漏到吸水溶液中.
- 达到前所未有的度水平,明显高于OSFO之前报告的研究.
- 最终的料溶液含有17%的PEG-400,表明有效的分离和度.
结论:
- 有机溶剂前透 (OSFO) 显示出作为一种非热性,具有成本效益的药物预缩方法具有显著的前途.
- 开发的基于聚烯的空心纤维膜对有机溶剂具有很高的耐受性和有效的度能力.
- 需要进行进一步的研究,以应对在制药行业成功实施OSFO的技术挑战.
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