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螺旋结参数和辅助剂成分对PEGylated配方产品稳定性的影响

Zarah Schaal¹, Pieter-Jan Van Bockstal², Joris Lammens²

¹RheaVita, Poortakkerstraat 9C, 9051 Ghent, Belgium; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, 9000 Ghent, Belgium.

International journal of pharmaceutics

|August 4, 2025

概括

配方辅助剂,而不是自旋结,在冷干燥后极大地影响PEGylated的稳定性. 基于三糖的配方提供优越的稳定性比曼尼托或糖-曼尼托混合物,特别是在压力条件下.

科学领域:

制药科学制药科学
生物技术是生物技术.
材料科学材料科学材料科学

背景情况:

冷干燥是稳定敏感生物分子 (如PEGylated) 的关键过程.
辅助剂的选择显著影响药物产品的稳定性和性能.
了解处理参数和配方之间的相互作用是成功冷化的关键.

研究的目的:

评估自旋结参数和配方成分对PEGylated的稳定性的影响.
为了比较基于三糖的配方与含有曼尼托尔或糖-曼尼托尔混合物的配方的稳定性.
确定PEGylated配方的冷干燥和储存的最佳条件.

主要方法:

对三种PEG化配方 (三糖,曼尼托尔,糖-曼尼托尔) 的比较稳定性研究.
在四个不同的自旋结条件下进行加工,然后进行批量干燥.
在2-8°C和50°C保存13周,对度,单体含量和蛋糕形态进行质量评估.

主要成果:

旋转结参数对配方中的或单体水平没有显著影响.
配方成分是稳定性的主要决定因素.
特雷哈洛斯配方表现出强大的稳定性;曼尼托尔配方在50°C下适度降解;糖-曼尼托尔配方在50°C下不稳定.

结论:

辅助剂的选择对于冷干燥后的PEGylated的稳定性至关重要.
与曼尼托尔或糖糖-曼尼托尔混合物相比,三糖是稳定PEGylated的优质辅助剂.
容易降解糖的配方可能需要专门的分析方法和优化的加工/储存条件.

关键词:

生物制药产品生物制药产品连续冷干燥的方法软化液化化是什么意思梅拉德反应是梅拉德反应.酸糖化是一种酸.的稳定性的稳定性

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