Development of an Inline Dry Powder Inhaler for Oral or Trans-Nasal Aerosol Administration to Children

Development of an Inline Dry Powder Inhaler for Oral or Trans-Nasal Aerosol Administration to Children
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DOI:
10.1089/jamp.2019.1540
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发表时间:
2019-08-29
影响因子:
3.4
通讯作者:
Longest, Worth
Longest, Worth
中科院分区:
医学4区
文献类型:
--
作者:
Farkas, Dale;Hindle, Michael;Longest, Worth

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背景:干粉吸入器(DPI)具有许多优点,例如快速输送大剂量吸入药物;然而,由于肺输送效率低且设备操作困难,通常避免在儿童中使用 DPI。本研究的目的是开发一种高效的内联 DPI,用于对儿童进行气雾疗法,并可选择使用口腔或经鼻方法。方法:开发了一种内联 DPI,它由空心入口和出口毛细管、粉末室以及鼻或口腔接口组成。使用通气袋或压缩空气来驱动该装置,同时提供与 5 岁儿童一致的完全深吸气。粉末室部分填充有质量为 10 mg 的模型喷雾干燥赋形剂增强生长粉末制剂。通过级联撞击来表征装置气雾化,并评估通过口腔和鼻体外模型的气雾传播。结果:当所有驱动空气都通过粉末室(无旁路流)时,实现了最佳设备性能,从而产生气溶胶平均质量中值空气动力学直径 (MMAD)
Background: Dry powder inhalers (DPIs) offer a number of advantages, such as rapid delivery of high-dose inhaled medications; however, DPI use in children is often avoided due to low lung delivery efficiency and difficulty in operating the device. The objective of this study was to develop a high-efficiency inline DPI for administering aerosol therapy to children with the option of using either an oral or trans-nasal approach. Methods: An inline DPI was developed that consisted of hollow inlet and outlet capillaries, a powder chamber, and a nasal or oral interface. A ventilation bag or compressed air was used to actuate the device and simultaneously provide a full deep inspiration consistent with a 5-year-old child. The powder chamber was partially filled with a model spray-dried excipient enhanced growth powder formulation with a mass of 10 mg. Device aerosolization was characterized with cascade impaction, and aerosol transmissions through oral and nasal in vitro models were assessed. Results: Best device performance was achieved when all actuation air passed through the powder chamber (no bypass flow) resulting in an aerosol mean mass median aerodynamic diameter (MMAD)