在生成蛋白质微粒的方面,基于重力和围静脉用于静脉输注之间的比较研究
Shavron Hada1, Sunkyong Ji1, Ye Na Lee1
1BK21 FOUR Team and Integrated Research Institute for Drug Development, College of Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea.
周围在生物制药中产生的可见颗粒比重力输液系统更少. 一个直线过器可以显著减少这些颗粒,特别是那些≥10μm的颗粒,保护药物的完整性.
科学领域:
- 生物制药的使用方法
- 药物输送系统是药物输送系统.
- 颗粒分析 颗粒分析
背景情况:
- 生物制药中的不可见颗粒可以导致免疫性,炎症和器官功能障碍.
- 输液系统的选择可以影响药物管理期间的颗粒生成.
研究的目的:
- 为了比较围静电和基于重力的输液系统之间的粒子生成.
- 为了评估在线过器在减少可见微粒方面的有效性.
主要方法:
- 比较Medifusion DI-2000 (环静电) 和Acu-Drip (重力) 输液套件.
- 静脉注射免疫球蛋白 (IVIG) 作为模型药物的使用.
- 在各种应力条件下,使用或不使用5μm直线过器进行颗粒水平评估.
主要成果:
- 环静电产生的微粒明显比重力系统更小.
- 5μm直线过器有效地减少了颗粒,特别是≥10μm的颗粒.
- 过器在暴露于油,落冲击和动后保持了颗粒减少效率.
结论:
- 输液系统的选择对于尽量减少生物制药中可见粒子生成至关重要.
- 在线过器对于保持颗粒控制至关重要,特别是对于敏感药物产品.
- 建议采用配有过器的适当输液系统,以确保生物制药的安全使用.
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