在无形固体分散中,水诱导的无形相分离的动力学,通过拉曼映射
Adrian Krummnow1,2, Andreas Danzer1, Kristin Voges2
1Laboratory of Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund University, Emil-Figge-Street 70, D-44227 Dortmund, Germany.
Pharmaceutics
|May 27, 2023
概括
这项研究量化了水诱导的无形相分离的动力学在无形固体分散 (ASDs) 里托纳维尔 (RIT) 和聚乙烯酸 (PVPVA). 这些发现与热力学预测一致,为ASD稳定性和药物生物可用性提供了洞察力.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 物理化学 物理化学
背景情况:
- 无形固体分散 (ASD) 增强了药物的生物可用性,但易受API结晶或相分离的影响.
- 水诱导的无形相分离可能会损害药物释放和疗效.
- 之前的研究已经确定了RIT/poly (PVPVA) ASDs中RIT/poly (PVPVA) 释放崩的热力学驱动因素.
研究的目的:
- 在RIT/PVPVA ASD中量化水诱导的无形相分离的动力学.
- 在相隔过程中确定演变无形相的组成.
- 为了验证在潮湿条件下ASD行为的热力学预测.
主要方法:
- 协焦拉曼光谱法用于现场监测无形相隔离.
- 间接硬模型被用于光谱数据评估.
- 在RIT/PVPVA ASD上进行了实验,在25°C和94%的相对湿度下,药物负载为20%和25%.
主要成果:
- 对于RIT/PVPVA ASDs,无形相分离的动力学已经成功量化.
- 在现场测量分离无形相的组成与三元相位图的预测非常相匹配.
- 该研究提供了第一个动态数据,用于水诱导无形相分离在这个ASD系统.
结论:
- 在RIT/PVPVA ASD中,水诱导的无形相分离的动力学和组成可以准确量化.
- 实验结果验证了PC-SAFT建模对ASD稳定性的预测能力.
- 了解这些动力学对于设计具有可预测药物生物可用性的稳定ASD配方至关重要.
相关概念视频
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