拉尼比祖马布在从港口交付平台的连续交付期间的稳定性
Aaron R Hieb1, Judit Horvath1, Jennifer Rea1
1Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
概括
拉尼比祖马布的港口输送系统 (PDS) 显示,拉尼比祖马布在植入物内稳定长达12个月. 这种创新的药物输送系统可以减少视网膜血管疾病的治疗负担.
科学领域:
- 眼科医生 眼科 眼科
- 药物输送系统 药物输送系统
- 生物材料是一种生物材料.
背景情况:
- 带有拉尼比祖马布 (PDS) 的港口输送系统提供了一种新的方法来治疗视网膜血管疾病,通过提供连续的眼内药物输送.
- PDS植入物是一种永久性设备,旨在在现场进行补充,旨在减少与频繁注射相关的治疗负担.
研究的目的:
- 在港口交付平台 (PD-P) 植入物中使用时,描述拉尼比祖马布的稳定性和降解.
- 评估拉尼比祖马布与PD-P的组件的兼容性,并评估其光稳定性.
主要方法:
- 模拟给药研究,以评估拉尼比祖马布与PD-P和商业成分的兼容性.
- 在12个月的体外释放研究中,使用酸盐缓冲盐水来模仿人类玻璃体.
- 建模研究,以评估植入物内的降解和光稳定性.
主要成果:
- 拉尼比祖马布与所有经过测试的PD-P和商业管理组件具有高度兼容性.
- 实验室研究表明,拉尼比祖马布在12个月内主要降解为酸性变体,其强度仍然很高.
- 由于PDS植入物的持续释放机制,尽管发生了一些退化,但释放的变体的每日质量很低.
结论:
- 港口输送系统与拉尼比祖马布兼容,并且在长时间内保持药物的效力.
- 拉尼比祖马布在PDS植入物中表现出可接受的稳定性,降解产品形成缓慢,每日释放率低.
- PDS代表了持续的拉尼比祖马布输送的可行选择,可能减少视网膜血管疾病的治疗负担.
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