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主要容器封闭系统对PS80氧化和机械理解的影响

Ryan Mould¹, Peter William Sargent¹, Yining Huang¹

¹Lilly Research Laboratories: Eli Lilly and Company, Indianapolis, Indiana, USA.

Pharmaceutical research

|July 11, 2023

概括

聚酸80 (PS80) 的氧化,导致药物降解,受到主要容器关闭系统的显著影响. 玻璃瓶加速PS80氧化,而聚合物瓶将其最小化,提供了一个新的缓解策略.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
分析化学分析化学

背景情况:

聚酸盐氧化是制药行业的一个关键问题,可能导致蛋白质降解和药物效能的丧失.
影响聚酸盐氧化的因素包括元素杂质,过氧化物含量,pH值和光照.
主要容器关闭系统 (CCS) 对聚酸盐氧化物的影响仍未得到充分研究.

研究的目的:

为了研究不同初级容器封闭系统对聚酸盐80 (PS80) 氧化的影响.
为了确定加速或减轻PS80降解的特定容器材料.

主要方法:

避孕药PS80配方被储存在各种玻璃和聚合物瓶中.
油酸含量被监测为PS80氧化的一个替代物.
诱导合等离子体质谱学 (ICP-MS) 和金属结研究被用于将金属可浸物与PS80氧化率相关联.

主要成果:

在高膨胀系数 (COE) 的玻璃瓶中,PS80的氧化速度最快,其次是低COE的玻璃瓶.
在大多数条件下,聚合物瓶显示了PS80氧化率最低的情况.
玻璃瓶中的金属化物含量较高与PS80氧化率的增加相关,和铁具有协同的催化效应.

结论:

主要容器关闭系统显著影响PS80氧化率.
这项研究确定容器材料是PS80稳定性的重要因素.
使用适当的初级容器,如聚合物瓶,可以作为缓解策略,以提高生物药物产品的稳定性.

关键词:

容器容器容器是一个容器.玻璃玻璃玻璃玻璃玻璃的玻璃.金属是金属,金属是金属.氧化过程中的氧化.聚酸盐是一种聚酸盐.

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