设计质量 - 喷雾干燥用于吸入的固剂量组合西普罗夫洛克萨-奎尔丁
Nasser Alhajj1, Niall J O'Reilly2, Helen Cathcart1
1Pharmaceutical and Molecular Biotechnology Research Centre (PMBRC), South East Technological University (SETU), Main Campus, Cork Road, Waterford X91 K0EK, Ireland.
International journal of pharmaceutics
|June 26, 2023
概括
喷雾干燥有效地产生无载体可吸入的药物颗粒,用于固定剂量组合. 优化的喷雾干燥参数产生了具有出色的气溶性能,用于肺部输送的西普罗夫洛克萨辛-奎尔塞丁颗粒.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 粒子工程 粒子工程
背景情况:
- 喷雾干燥是创建固定剂量药物组合的关键技术,特别是无载体可吸入颗粒.
- 优化喷雾干燥对于实现肺部管理所需的颗粒特性至关重要.
研究的目的:
- 为了优化喷雾干燥过程,用于肺部输送的西普罗夫洛克萨-奎尔塞丁固定剂量组合.
- 了解过程参数和粒子特征之间的关系.
主要方法:
- 为了研究过程变量,采用了24-1的分数因数设计.
- 多变量数据分析,包括主要组件分析,用于关联参数和结果.
- 研究的关键变量包括溶液度,溶液流速,原子化空气流速和入口温度.
主要成果:
- 入口温度显著影响了剩余水分含量和产量.
- 颗粒大小分布 (D(v,50),D(v,90)) 受流速和入口温度的影响.
- 优化的配方实现了2.42μm的D(v,50),跨度为1.81,产量>70%,剩余水分含量低 (3.4%).
结论:
- 这项研究成功地优化了固剂量普洛素-奎尔塞丁组合的喷雾干燥参数.
- 优化的配方表现出了卓越的体外气溶性能,具有高排放剂量 (> 80%) 和微粒分数 (> 70%).
- 喷雾干燥是一种可行的方法,用于生产可吸入的固定剂量药物组合,具有理想的空气动力学特性.
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