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无形固体分散物的长期物理稳定性测试的统计分析

Jingya Wu¹, Guy Van den Mooter¹

¹Drug Delivery and Disposition, KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Campus Gasthuisberg ON2, Herestraat 49 b921, 3000 Leuven, Belgium.

International journal of pharmaceutics

|June 15, 2025

概括

无形固体分散 (ASDs) 的稳定性是复杂的. 这项研究发现,分子间结和湿度显著影响ASD的物理稳定性,从而能够更好地预测药物配方结果.

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:

无形固体分散 (ASD) 对于提高药物的溶解性和生物可用性至关重要.
了解影响ASD物理稳定的因素对于有效的药物配方至关重要.
由于复杂的潜在机制,预测ASD的长期稳定性仍然是一个挑战.

研究的目的:

研究程序和分子层面因素对无形固体分散 (ASD) 的长期物理稳定性的影响.
确定影响ASD结晶率的关键变量.
开发一个统计学上可靠的框架来预测ASD稳定性.

主要方法:

六种模型药物的配方用聚乙烯基合乙烯酸 (PVPVA) 制成ASD,使用基于溶剂和机械化学方法.
在五种不同的温度和湿度条件下,在最大药物负载下进行一年的稳定性研究.
应用物流回归和生存分析来定量评估稳定性因素.

主要成果:

分子间结被确定为影响ASD稳定的重要因素,其影响因药物特定结晶趋势而有所不同.
在所有统计模型中,始终发现储存环境的湿度对ASD稳定性产生重大影响.
该研究表明,结合,湿度和ASD结晶率之间存在强烈的相关性.

结论:

分子间结和环境湿度是无形固体分散稳定性的关键预测因素.
对实验数据的统计分析为优化ASD设计和预测稳定性提供了强大的见解.
这项研究提供了一种定量方法,以加强稳定的无形固体分散剂量形式的开发.

关键词:

无形固体的分散性固体.在冷加工过程中,冷磨.结晶的趋势结晶趋势电气喷雾是一种电子喷雾.通过气结合,形成了气结合.长期物理稳定性长期物理稳定性喷雾干燥喷雾干燥统计分析统计分析

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