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玻璃油免费预装注射器作为自动注射器中的主要容器

Xi Zhao^1,2, Yueli Chen³, Hassen Hamzaoui³

¹Pharmaceutical Sciences & Clinical Supply, Merck & Co., Inc., Rahway, NJ, 07065, USA. xi.zhao7@lilly.com.

Pharmaceutical research

|December 5, 2024

概括

与标准的化预填注射器 (PFS) 相比,无油 (SOF) 注射器提供了更好的蛋白质稳定性. SOF注射器表现出类似的功能,为生物治疗药物提供提供了一个有希望的替代方案.

科学领域:

制药科学制药科学
生物技术是生物技术.
材料科学材料科学材料科学

背景情况:

预填注射器 (PFS) 广泛用于生物治疗药物输送.
化PFS由于油水界面相互作用,可能会对蛋白质稳定性产生负面影响.
无油 (SOF) 系统为提高生物制药产品稳定性提供了一个潜在的解决方案.

研究的目的:

评估SOF玻璃注射器与化注射器对蛋白质稳定性的影响.
评估SOF注射器作为生物治疗的主要容器的设备功能.
为了比较SOF和化PFS在组合产品中的性能.

主要方法:

在SOF和化注射器中,在各种温度条件下,长达六个月的时间内评估了蛋白质的稳定性.
使用微流成像 (MFI) 和超高性能尺寸排除色谱 (UP-SEC) 量化了可见的粒子和可溶性聚合物.
评估了设备的功能 (破解力,挤出力,输送时间),包括SOF注射器溶液粘度的影响.

主要成果:

SOF注射器表现出优异的蛋白质兼容性,并且颗粒数量明显低于化PFS.
虽然SOF注射器的初始破解和挤出力较高,但随着时间的推移,它们的功能保持稳定.
与化注射器不同的是,在稳定性测试期间没有观察到SOF注射器功能的显著变化.

结论:

SOF玻璃注射器,搭配PTFE涂层的堵塞器,提供了一个可行的主要容器关闭系统.
该系统确保了足够的蛋白质稳定性,并保持了理想的设备功能.
SOF注射器是生物制品的有希望的替代包装,提供更高的稳定性和可靠的性能.

关键词:

自动注射器的自动注射器突破松动力的力量交付时间交付时间挤出力是一种挤出力.预先填充注射器 (PFS) 的使用这是一种蛋白质配方.没有油 (SOF) 的玻璃注射器.在注射器的功能.

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