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防腐剂和单克隆抗体之间的相互作用,以支持多剂量配方开发

Sachini P Karunaratne¹, Madeleine C Jolliffe², Isabelle Trayton²

¹Department of Chemistry, The University of Kansas, Lawrence KS, USA.

International journal of pharmaceutics

|November 15, 2023

概括

多剂量配方中的抗微生物防腐剂 (AP) 可能会影响药物的稳定性. 醇对NIST mAb的影响很小,而和m-cresol增加了可见的粒子,并降低了结构稳定性.

科学领域:

制药科学制药科学制药科学
生物制剂配方生物制剂配方
药物产品的稳定性药物产品的稳定性

背景情况:

多剂量配方为患者提供方便,但需要抗微生物防腐剂 (APs) 来防止微生物污染.
选择适当的AP对于保持药物产品稳定性至关重要,这在配方开发中构成了重大挑战.

研究的目的:

评估三种常见的APs (醇,,m-cresol) 对模型免疫球蛋白G1单克隆抗体 (NIST mAb) 的构造和储存稳定性的影响.

主要方法:

使用交换质谱 (HX-MS) 和差分扫描热量计 (DSC) 来评估构造稳定性.
使用可见微粒 (SVP) 分析和尺寸排除色谱 (SEC) 在40°C下4周评估存储稳定性.

主要成果:

所有测试的AP都降低了NIST mAb的结构稳定性,增加了C_H2域的灵活性.
醇造成了最显著的不稳定,其次是m-cresol和醇.
和m-cresol在储存期间增加了不可见粒子,而醇则没有. 没有观察到任何AP的单体含量或可溶性聚合物的显著变化.

结论:

醇似乎是NIST mAb配方测试选项中最合适的防腐剂,对稳定性影响最小.
和m-cresol对NIST mAb的稳定性产生负面影响,增加粒子形成并降低结构完整性.

关键词:

抗微生物防腐剂抗微生物防腐剂配方配方是一种配方.交换质谱仪的质谱仪.一个单克隆抗体的抗体.蛋白质的稳定性蛋白质的稳定性

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