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溶液压缩计量剂量吸入器喷雾剂与低GWP推进剂的体外评估

Daniel J Duke¹, Lingzhe Rao², Benjamin Myatt³

¹Department of Mechanical & Aerospace Engineering, Monash University, Clayton, 3168, Victoria, Australia. daniel.duke@monash.edu.

Pharmaceutical research

|February 12, 2025

概括

在计量剂量吸入器 (pMDIs) 中使用低全球变暖潜力 (GWP) 推进剂的过渡影响了药物输送. HFO1234ze(E) 的性能与HFA134a相似,而HFA152a改变了羽毛的特性,表明了生物等效的配方和装置修改.

科学领域:

制药科学制药科学
吸入技术吸入技术
环境科学环境科学

背景情况:

压力计量剂量吸入器 (pMDIs) 正在从高全球变暖潜力 (GWP) 推进剂 (如HFA134a) 过渡到低GWP替代品,如HFA152a和HFO1234ze(E).
由于推进剂的物理化学性质发生了变化,这种转变在保持产品性能和体外生物等价性方面带来了挑战.

研究的目的:

与HFA134a相比,研究低GWP推进剂 (HFA152a,HFO1234ze(E)) 对pMDI性能的影响.
用同等的pMDI硬件和配方来评估空气动力学颗粒尺寸分布 (APSD) 和羽毛特征.

主要方法:

使用了空气动力学粒子大小分布 (APSD) 测量,激光衍射和高速成像.
对比HFA134a,HFA152a和HFO1234ze (((E) 溶液配方的贝克洛米他松二 propionate. 在此,我们将其与HFA134a,HFA152a和HFO1234ze (((E) 溶液配方进行比较.
研究的仅推进剂的安慰剂,无辅助溶剂的溶液和乙醇溶液 (8%和15%重/重).

主要成果:

与HFA134a相比,HFA152a配方显示药物沉积增加和不太稳定,可重复的羽毛.
HFO1234ze(E) 配方的APSD性能与HFA134a相比较,羽毛传播速度较慢.
添加乙醇缓和了推进剂之间的差异,影响了羽毛状特征.

结论:

羽毛稳定性和射击对射击的重复性是影响配方差异的关键因素,特别是前口罩.
对执行器孔和口腔体几何的修改可能会改善低GWP pMDIs 的体外生物等价性.
配方和设备设计的调整可以管理性能差异,为未来的低GWP pMDI开发提供基准数据.

关键词:

在HFA152a中,HFO1234ze(E) 是一种高度的物质.具有低GWP的气体变压效应在 pMDI 的情况下,pMDI 是 pMDI.推进剂是一种推进剂.

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