通过有机溶剂前透来进行高度制药预度的实用透剂
Ryoichi Takada1,2, Ryosuke Takagi3, Zhaohuan Mai3
1Asahi Kasei Corporation, Tokyo 100-0006, Japan.
Membranes
|September 27, 2024
概括
有机溶剂前透 (OSFO) 预度使用聚烯糖醇 (PPG) -400在甲醇中实现了高纯度的糖八酸盐. 这种方法显著减少了杂质,符合制药生产标准.
科学领域:
- 化学工程是化学工程的重要组成部分.
- 分离过程 分离过程.
- 制药技术 制药技术 制药技术
背景情况:
- 预度对于降低制药生产成本至关重要.
- 有机溶剂前透 (OSFO) 提供非热,低成本,高度的能力.
- 以前的OSFO试图使用聚乙烯糖醇 (PEG) -400导致无法接受的溶液污染.
研究的目的:
- 为了确定一个实用的透剂OSFO前度在制药应用中.
- 为了证明一种新的透剂在达到高纯度方面的有效性.
- 为了达到严格的制药生产纯度标准.
主要方法:
- 选潜在的透剂基于实际的标准,如毒性,可溶性和粘度.
- 选择聚烯糖醇 (PPG) -400作为最佳的透剂.
- 使用PPG-400与甲醇中的糖八酸盐 (SoA) 进行OSFO预度的演示.
主要成果:
- 聚乙烯甘醇 (PPG) -400因其有利的特性被确定为一种合适的透剂.
- 在甲醇中的糖乙酸盐 (SoA) 使用OSFO.成功地从9.4%重量缩到48%重量缩.
- 最终的缩溶液仅含有0.04重量%的PPG-400,符合制药纯度要求.
结论:
- PPG-400是一种有效的透剂,用于OSFO在制药制造中的预度.
- 这项研究展示了OSFO在缩前满足制药纯度标准的首次成功演示.
- 与PPG-400一起的OSFO提供了一个可行的解决方案,用于具有成本效益和高纯度的药物中间度.
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