聚合物作为喷雾干燥蛋白质配方的稳定辅料
Chanakya D Patil1, Yijing Huang1, Kinnari Santosh Arte1
1Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN, 47907, USA.
Pharmaceutical research
|December 22, 2025
概括
新的聚合物辅助剂 (2-基) -β-环氧 (HPβCD) 和水解凝增强了喷雾干燥牛血清白蛋白 (BSA) 的稳定性. 这些替代品比生物药物产品的传统糖稳定剂更有希望.
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:
- 生物制药产品在储存期间需要稳定,通常通过干燥技术实现.
- 喷雾干燥是一种高通量替代冷干燥的方法,可提高药物产品的稳定性.
- 稳定辅助剂对于保护敏感蛋白质在加工和储存期间免受降解至关重要.
研究的目的:
- 评估基于多糖和蛋白质酸盐的聚合物辅料作为替代传统稳定剂如三和曼尼托尔的替代品.
- 评估 (2-hydroxypropyl) -β-cyclodextrin (HPβCD) 和水解凝对喷雾干燥牛血清白蛋白 (BSA) 的稳定潜力.
- 为了比较新型辅助剂与传统的糖稳定剂在喷雾干燥和储存期间保护蛋白质的疗效.
主要方法:
- 使用HPβCD,水解凝,20kDa的德克斯或碳糖甲基纤维素 (NaCMC) 制备喷雾干燥的BSA配方,含有或不含有三醇或曼尼托尔.
- 通过监测在压力储存条件下 (40°C3个月) 的单体损失来评估蛋白质稳定性.
- 分析结晶性 (PXRD),二次结构变化 (ssFTIR),粒子特征和复制时间.
主要成果:
- 与单独的三糖或曼尼托尔相比,含有HPβCD或水解凝的配方表明BSA单体损失明显较低.
- 德克斯特兰20 kDa和NaCMC配方表现出蛋白质稳定性较差.
- 粉末X射线衍射揭示了盐结晶,固态里埃变换红外光谱学表明了随着时间的推移BSA的二次结构变化.
结论:
- HPβCD和水解凝有效地提高了喷雾干燥的BSA的物理稳定性.
- 这些聚合物辅料显示出与传统的基于糖的稳定剂相比,作为优质稳定剂添加剂的潜力.
- 这些发现支持使用HPβCD和水解凝来增强蛋白质制药的稳定性.
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