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不要动摇它,不要动摇它! 机械应力测试的mRNA-脂质纳米颗粒

Anna Ruppl¹, Denis Kiesewetter¹, Franziska Strütt¹

¹Department of Pharmaceutics, Institute of Pharmaceutical Sciences, University of Freiburg, Sonnenstr. 5 79104, Freiburg i. Br., Germany.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|March 16, 2024

概括

在运输过程中震动液体脂质纳米粒子 (LNP) 可以降解核酸含量并增加颗粒大小. 淋化LNP配方表现出对机械应力的优越稳定性,突出了它们改善药品保质期的潜力.

科学领域:

制药科学制药科学
生物技术是生物技术.
药物运输药物运输药物运输

背景情况:

配方开发通常包括摇动应激研究,以评估运输期间药物产品的稳定性.
液体配方易受界面应力影响,因此需要评估机械稳定性.
脂质纳米粒子 (LNP) 是核酸的关键输送系统,需要强大的配方策略.

研究的目的:

评估各种动程序对载有核酸的LNP稳定性的影响.
为了比较液体与冷化LNP配方的机械应力易感性.
为了确定影响LNP在震动应力下降解的关键参数.

主要方法:

在不同速度 (300-600rpm) 和方向上对聚乙烯酸 (polyA) 替代物和增强绿色光蛋白 (eGFP) -LNP溶液进行轨道震动.
对封装核酸含量,LNP大小和多分散性指数 (PDI) 的分析.
评估冷化LNP剂量形式的稳定性和与液体配方的比较.

主要成果:

震动液LNP降低了封装核酸含量,增加了LNP大小,并减少了PDI.
观察到小瓶表面的白色沉积物形成,受时间,速度,温度和包装的影响.
淋化LNP保持了蛋糕完整性和产品特性,显示出比液体配方更大的稳定性.

结论:

震动应力显著影响液态核酸加载液态核酸LNP的稳定性.
软化提供了一种可行的策略,可以增强LNP对机械应力的稳定性.
在运输条件下纳入震动应力研究对于LNP配方的技术开发至关重要.

关键词:

配方开发配方开发介面应力是指面际应力.脂质纳米颗粒的使用方法淋化剂型的剂量形式.纳米粒子药物输送系统基于核酸的治疗药物.亲肠道配方可以使用.的震动在的震动中

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