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经鼻高流量系统输送粉末气雾剂:体外可行性及工艺条件的影响。

Powder aerosol delivery through nasal high-flow system: In vitro feasibility and influence of process conditions.

机构信息

Advanced Drug Delivery Group, Faculty of Pharmacy, The University of Sydney, Sydney, 2006 NSW, Australia; Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku-ku, Nagoya 468-8503, Japan.

Advanced Drug Delivery Group, Faculty of Pharmacy, The University of Sydney, Sydney, 2006 NSW, Australia.

出版信息

Int J Pharm. 2017 Nov 25;533(1):187-197. doi: 10.1016/j.ijpharm.2017.08.079. Epub 2017 Aug 19.

Abstract

We aimed to obtain fundamental information for potential pulmonary delivery of powder aerosols using a clinically-approved nasal high-flow system (AIRVO), with spray-dried mannitol (SD-Man) being a model powder. Compressed air exiting the AIRVO at set 'dispersion' air flow rates dispersed SD-Man loaded in an Osmohaler into a human nasal airway replica (NAR) coupled downstream to a Next Generation Impactor (NGI) running at specific 'inspiratory' flow rates. Increasing the dispersion flow rate from 30 to 60L/min increased powder deposition in the NAR from 50 to 70% of the emitted dose, while decreased the NGI deposition from 50 to 30% of the emitted dose. The inspiratory flow rate did not affect powder deposition in the NAR and NGI. In contrast, as the inspiratory flow rate was increased from 15 to 40L/min, powder recovery, emitted fraction, and fine particle fraction below 5μm (as aerosol performance indices) were increased from 90, 30 and 5% to 97, 45 and 8% of the loaded dose, respectively. The dispersion flow rate did not change the performance indices. Importantly, heating and humidification of dispersion airflow, loaded doses, and nasal cannula sizes did not greatly affect the aerosol characteristics.

摘要

我们旨在使用临床批准的鼻高流量系统 (AIRVO) 获得粉末气溶胶潜在肺部给药的基本信息,以喷雾干燥甘露醇 (SD-Man) 为模型粉末。从 AIRVO 中以设定的“分散”空气流速逸出的压缩空气将装入 Osmohaler 中的 SD-Man 分散到与人鼻气道模型(NAR)下游耦合的下一代撞击器(NGI)中,以特定的“吸气”流速运行。将分散流速从 30 增加到 60L/min ,使 NAR 中粉末沉积从发射剂量的 50%增加到 70%,而 NGI 沉积从发射剂量的 50%减少到 30%。吸气流速不影响 NAR 和 NGI 中的粉末沉积。相比之下,随着吸气流速从 15 增加到 40L/min ,粉末回收、发射分数和小于 5μm 的细颗粒分数(作为气溶胶性能指标)分别从加载剂量的 90%、30%和 5%增加到 97%、45%和 8%。分散流速不会改变性能指标。重要的是,分散气流、加载剂量和鼻插管尺寸的加热和加湿并没有极大地影响气溶胶特性。

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