使用直角分析技术对干粉吸入器配方进行微结构性表征
Gonçalo Farias1,2, William J Ganley3,4, Robert Price3,4
1Pharmaceutical Surface Science Research Group, Department of Pharmacy & Pharmacology, University of Bath, Bath, UK. goncalo.farias01@aptar.com.
Pharmaceutical research
|October 7, 2024
概括
形态定向拉曼光谱 (MDRS) 和溶解是有效的直角技术,用于评估干粉吸入器 (DPI) 气溶剂剂量的微观结构等价性. 这些方法有助于将材料特性与体内性能联系起来.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 分析化学 分析化学
背景情况:
- 干粉吸入器 (DPI) 需要强大的分析方法来评估药物产品的性能.
- 了解材料特性和加工对体内性能的影响对于局部起作用的DPI至关重要.
- 气溶剂剂量的微观结构等价性是DPI疗效的一个关键因素.
研究的目的:
- 探索形态定向拉曼光谱 (MDRS) 和溶解作为直角技术的实用性.
- 评估DPI的气溶剂剂量的微观结构等价性.
- 了解材料特性和加工对体内性能的影响.
主要方法:
- 商业DPI含有流动 propionate (FP) 和沙米特醇新酸 (SX) 的来源.
- 进行了空气动力学颗粒尺寸分布 (APSD),溶解和MDRS研究.
- 原则组件分析被用来识别有歧视性的聚合物类.
主要成果:
- 单独的APSD测试可能无法完全解释体内性能差异.
- 溶解研究显示,不同商业FP/SX产品的溶解率不同.
- MDRS结果支持溶解发现,将溶解速率与可溶性成分分数相关联.
结论:
- MDRS和溶解成功地成为分析DPI喷雾剂量的直角技术.
- 这些体外方法提供了材料属性/工艺参数与体内性能之间的有价值的联系.
- 进一步开发DPI的体外评估工具被强调为重要.
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