聚酸盐稳定性: 包装材料,缓冲器,对冲器和pH值的影响
Blaž Lebar1, Tinkara Lekić1, Pija Košir2
1Novartis Pharmaceutical Manufacturing LLC, Verovškova ulica 57, 1000, Ljubljana, Slovenia; Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000, Ljubljana, Slovenia.
International journal of pharmaceutics
|September 12, 2024
概括
塑料瓶中的可浸物和酸盐缓冲剂抑制了聚酸盐 (PS) 的降解,影响了药物配方的稳定性. 这项研究揭示了在温度压力下影响PS水解的关键因素.
科学领域:
- 制药科学 制药科学
- 生物制药开发 生物制药开发
- 药物的稳定性 药物的稳定性
背景情况:
- 聚酸盐 (PS) 是药物配方中至关重要的辅助成分.
- 复杂的降解途径对聚酸盐的稳定性构成了重大挑战.
- 了解聚酸盐水解对于有效的生物制药开发至关重要.
研究的目的:
- 在热应力下研究聚酸盐 (PS) 水解.
- 为了评估初级包装,缓冲器,对冲器和pH对PS稳定性的影响.
- 阐明不同配方中聚酸盐降解的机制.
主要方法:
- 在不同条件下在50°C进行的水解实验.
- 使用西格形配件分析聚酸盐降解动力学.
- 主要组件分析 (PCA) 以确定关键影响因素.
- 玻璃与塑料瓶的比较以及化物与酸盐的比较.
主要成果:
- 塑料瓶中的可溶性物质在histidine和酸缓冲器中显著抑制了聚酸盐降解.
- 对于histidine和酸缓冲剂,观察到明显的降解机制.
- 马拉酸,与histidine结合,证明了对聚酸盐水解的抑制作用.
- 动力分析显示了降解速率和模式的显著差异.
结论:
- 助剂和初级包装材料极大地影响了聚酸盐的稳定性.
- 塑料瓶中的可浸物对聚酸盐降解具有保护作用.
- 酸盐对子可以调节多酸盐水解速率.
- 这些发现为优化生物制药配方和确保药品保质期提供了必要的见解.
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