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在使用既定和新推进剂的压力计量剂量吸入器中使用脂微粒的可行性

Zahra Minootan¹, Hui Wang², Patrick Connaughton³

¹Donadeo Innovation Centre for Engineering (DICE), 9211 116 Street NW, Edmonton, Alberta, T6G1H9, Canada.

AAPS PharmSciTech

|April 10, 2024

概括

新型脂颗粒 (RLPs) 在压力计量剂量吸入器 (pMDIs) 中表现出极好的物理稳定性. 这些RLP保持其结构和悬浮,提供了一个有前途的替代方案,以当前和下一代推进剂一致的肺部输送.

科学领域:

制药技术制药技术制药技术
材料科学材料科学材料科学
药物输送系统药物输送系统

背景情况:

压力计量剂量吸入器 (pMDIs) 需要稳定的配方才能有效地传递到肺部.
开发新的药物载体对于优化pMDI性能和推进剂兼容性至关重要.

研究的目的:

调查新型脂颗粒 (RLP) 在pMDI配方中作为药物载体的可行性.
评估各种推进剂中RLP的物理和体稳定性,包括低全球变暖潜力 (GWP) 选项.

主要方法:

在不同的入口温度 (55°C和75°C) 下喷雾干燥RLP.
在3个月内评估HFA-134a,HFA-227ea和HFO-1234ze推进剂的RLP稳定性.
使用影像图像和场辐射电子显微镜与能量分散式X射线光谱学进行粒子分析.

主要成果:

在所有测试的推进剂中,RLP配方 (RLP55和RLP75) 显示出出色的悬浮稳定性.
RLPs保留了它们的 rugose 结构和合体稳定性,超过了 80% 的 trehalose/20% 的 leucine 配方.
稳定性与已建立的工程孔隙颗粒可比.

结论:

粗糖脂质颗粒 (RLP) 具有高度稳定性,适用于pMDI配方.
RLPs显示出与当前的HFA推进剂和下一代低GWP推进剂 (如HFO-1234ze.ze) 两种使用的巨大潜力.
这项研究支持RLP作为一种可行的药物输送系统,用于先进的pMDI应用.

关键词:

低GWP推进剂的推进剂这是一种pMDIs.粒子工程是什么?粒子工程是什么?脂质是一种脂质.喷雾干燥喷雾干燥

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