化蛋白配方作为以患者为中心的剂量形式:为可持续发展范式做出贡献
Maja Bjelošević Žiberna1, Pegi Ahlin Grabnar1, Mirjana Gašperlin1
11University of Ljubljana, Faculty of Pharmacy, Department of Pharmaceutical Technology, 1000 Ljubljana, Slovenia.
Acta pharmaceutica (Zagreb, Croatia)
|May 30, 2024
概括
药品配方中的蛋白质度增加会增加粘度和溶解时间,但不会提高蛋白质的稳定性. 糖糖对于冷化至关重要,与曼尼托尔一起.
科学领域:
- 制药技术 制药技术 制药技术
- 生物化学 生物化学
- 药物输送系统 药物输送系统
背景情况:
- 人口老龄化和气候变化需要创新的制药技术.
- 蛋白质药物,特别是用于皮下注射的药物,在稳定性和配方粘度方面面临挑战.
- 单克隆抗体配方的开发需要进一步的蛋白质行为数据.
研究的目的:
- 评估蛋白质度对液体和冷化配方的关键质量属性的影响.
- 调查诸如糖和曼尼托尔等辅助剂在蛋白质配方稳定性和冷化中的作用.
- 增强单克隆抗体配方开发的数据平台.
主要方法:
- 使用牛血清白蛋白作为模型蛋白质系统.
- 预溶解液体配方和冷产品的分析.
- 评估关键质量属性,包括粘度,溶解时间和蛋白质稳定性.
主要成果:
- 证实了假设:蛋白质度增加导致粘度和溶解时间更高.
- 蛋白质稳定性没有受到蛋白质度增加的显著影响.
- 糖被确定为模型蛋白质的冷化过程中的关键辅助剂.
结论:
- 蛋白质度是影响配方粘度和溶解时间的关键因素.
- 糖糖在成功的蛋白质冷化中起着至关重要的作用.
- 曼尼托在冷化中的有益作用可能取决于其相对于糖的度.
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