结合型糖聚合物分散剂用于增强加工和储存稳定性
Claudia Giannachi1,2, Evin Allen2, Gráinne Egan2
1SSPC, the SFI Research Centre for Pharmaceuticals, School of Pharmacy, University College Cork, Cork T12 YT20, Ireland.
Molecular pharmaceutics
|May 17, 2024
概括
聚烯 (PVP) 和PVPVA增强了蛋白质疗法的无形糖的稳定性. 由于增加了结合,PVP比PVPVA更好地稳定了三糖再结晶.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 生物技术是生物技术.
背景情况:
- 蛋白质疗法需要在干燥配方中进行稳定.
- 无形固态糖如糖和三糖是稳定性的关键辅助成分.
- 使用聚合物如聚乙烯 (PVP) 和聚乙烯酸乙烯 (PVPVA) 的聚化可提高无形糖的稳定性.
研究的目的:
- 为了研究聚合糖聚合物系统的稳定性.
- 评估聚合物类型和度对冷,干燥和潮湿状态下的糖稳定性的影响.
- 了解结和高透性在无形固态稳定中的作用.
主要方法:
- 糖糖或三糖与PVP或PVPVA在不同比率 (2:8到8:2) 的结合型化.
- 使用玻璃过渡温度 (Tg') 测量的冷溶液状态稳定性的分析.
- 使用动态蒸汽吸附 (DVS) 湿度提升实验评估干燥状态稳定性和水吸附效应.
主要成果:
- 冷糖-PVPVA溶液的Tg'比糖-PVP溶液的Tg'更高.
- 所有化系统都显示了类似的Tg值.
- 糖系统在暴露于湿度时表现出比三醇系统更大的无形稳定性.
- 添加PVP比PVPVA更有效地抑制了三糖再结晶,特别是在较低度下.
结论:
- 聚合物高度和键相互作用显著影响无形分散的固态稳定性.
- 与PVPVA相比,PVP与糖的结合更强,增强了无形稳定性并抑制了再结晶.
- 这些发现对于开发稳定生物制药固态配方至关重要.
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