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最近在干燥和开发稳定的mRNA和siRNA脂质纳米粒子固体配方方面的进展

Kinnari Santosh Arte¹, Manlin Chen¹, Chanakya D Patil¹

¹Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN 47907, USA.

Journal of pharmaceutical sciences

|December 18, 2024

概括

将液体RNA脂质纳米颗粒 (LNP) 转化为固体形式可以改善室温储存. 了解干燥对RNA/LNP稳定性的影响对于开发稳定,固态配方至关重要.

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:

目前的RNA脂质纳米粒子 (LNP) 产品是需要超冷储存的液体配方.
这就需要开发稳定,可在室温下储存的配方,以提高可访问性和减少后勤负担.

研究的目的:

审查各种干燥技术,以将RNA/LNP配方转化为固体形式.
分析干燥过程对RNA/LNP系统稳定性和特性的影响.
确定影响稳定,固态RNA/LNP产品成功开发的关键因素.

主要方法:

干燥技术的文献综述,包括冷化,喷雾干燥和喷雾冷干燥.
分析配方,工艺参数和制造环境对干燥结果的影响.
评估固态产品的属性,如外观,水分含量,流动性质和复制时间.

主要成果:

干燥过程可以显著影响RNA/LNP配方的稳定性.
干燥技术的选择取决于输送方式,脂质成分和所需的产品特性.
过程参数极大地影响最终固态RNA/LNP产品的物理和化学稳定性.

结论:

了解干燥引起的应力对于增强RNA/LNP稳定性至关重要.
优化干燥技术和参数是实现稳定,室温可存储的RNA/LNP配方的关键.
本综述为基于RNA/LNP的系统选择合适的干燥方法提供了见解.

关键词:

干燥技术干燥技术脂质纳米颗粒是一种纳米粒子.软化液化化是什么意思这是一个RNARNARNARNARNA.喷雾干燥喷雾干燥喷雾冷干燥的喷雾方式稳定的稳定性稳定的稳定性

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