在固体分散中的多态性.
Karina Sanabria Ortiz1,2, José R Hernández Espinell1,2, Desire Ortiz Torres1,2
1Department of Chemistry, University of Puerto Rico, Río Piedras Campus, San Juan, Puerto Rico 00931, United States.
Crystal growth & design
|December 18, 2023
概括
制备方法显著影响固体分散的多态形式. 融合方法产生混合多态,而基于溶剂的方法产生单晶形式,这对于准确的相位图和药物质量至关重要.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 固体分散通过在聚合物载体中嵌入活性药物成分 (API) 来提高药物的溶解性.
- 常见的制备技术包括溶剂蒸发,溶剂融合和融合方法.
- 这些技术经常用于相位图的确定,但它们对API多态性的影响还未得到充分研究.
研究的目的:
- 研究不同制备方法对晶体固体分散 (CSD) 的多态形式的影响.
- 分析制备技术对流胺酸 (FFA) 和聚乙烯糖醇 (PEG) 系统相图测定的影响.
主要方法:
- 使用溶剂蒸发,溶剂融合和融合方法制备晶体固体分散剂 (CSD).
- 使用粉末X射线衍射 (PXRD),红外光谱 (IR) 和差分扫描热量计 (DSC) 进行物理混合物和CSD的表征.
主要成果:
- 融合方法导致CSD中同时存在的芬胺酸多态 (FFA I和FFA III).
- 溶剂蒸发和溶剂融合方法主要产生了FFA III多态.
- 准备方法显著影响了相位图的确定,平均相对偏差小于或等于8%.
结论:
- 准备方法的选择极大地影响了固体分散的多态结果.
- 精确的相位图的确定,对于工艺设计和质量控制至关重要,取决于选择适当的制备技术.
- 了解制备方法对多态性的影响,可以确保制药配方的关键质量属性.
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