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高效干粉吸入器的研发:胶囊腔室设计及吸入器表面改性的影响

Development of a high efficiency dry powder inhaler: effects of capsule chamber design and inhaler surface modifications.

作者信息

Behara Srinivas R B, Farkas Dale R, Hindle Michael, Longest P Worth

机构信息

Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, 401 West Main Street, P.O. Box 843015, Richmond, Virginia, 23284-3015, USA.

出版信息

Pharm Res. 2014 Feb;31(2):360-72. doi: 10.1007/s11095-013-1165-6. Epub 2013 Aug 16.

Abstract

PURPOSE

The objective of this study was to explore the performance of a high efficiency dry powder inhaler (DPI) intended for excipient enhanced growth (EEG) aerosol delivery based on changes to the capsule orientation and surface modifications of the capsule and device.

METHODS

DPIs were constructed by combining newly designed capsule chambers (CC) with a previously developed three-dimensional (3D) rod array for particle deagglomeration and a previously optimized EEG formulation. The new CCs oriented the capsule perpendicular to the incoming airflow and were analyzed for different air inlets at a constant pressure drop across the device. Modifications to the inhaler and capsule surfaces included use of metal dispersion rods and surface coatings. Aerosolization performance of the new DPIs was evaluated and compared with commercial devices.

RESULTS

The proposed capsule orientation and motion pattern increased capsule vibrational frequency and reduced the aerosol MMAD compared with commercial/modified DPIs. The use of metal rods in the 3D array further improved inhaler performance. Coating the inhaler and capsule with PTFE significantly increased emitted dose (ED) from the optimized DPI.

CONCLUSIONS

High efficiency performance is achieved for EEG delivery with the optimized DPI device and formulation combination producing an aerosol with MMAD < 1.5 μm, FPF<5 μm/ED > 90%, and ED > 80%.

摘要

目的

本研究的目的是基于胶囊方向的改变以及胶囊和装置的表面修饰,探索一种用于辅料增强生长(EEG)气雾剂递送的高效干粉吸入器(DPI)的性能。

方法

通过将新设计的胶囊腔室(CC)与先前开发的用于颗粒解聚的三维(3D)棒阵列以及先前优化的EEG制剂相结合来构建DPI。新的CC使胶囊垂直于进入的气流定向,并在装置上恒定压降的情况下针对不同的进气口进行分析。对吸入器和胶囊表面的修饰包括使用金属分散棒和表面涂层。评估了新型DPI的雾化性能,并与商用装置进行了比较。

结果

与商用/改良DPI相比,所提出的胶囊方向和运动模式提高了胶囊振动频率并降低了气雾剂的质量中值空气动力学直径(MMAD)。在3D阵列中使用金属棒进一步改善了吸入器性能。用聚四氟乙烯(PTFE)涂覆吸入器和胶囊显著提高了优化后的DPI的递送剂量(ED)。

结论

通过优化的DPI装置和制剂组合实现了EEG递送的高效性能,产生的气雾剂MMAD <1.5μm,细颗粒分数(FPF)<5μm/递送剂量(ED)> 90%,且ED> 80%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f80e/3946921/46bdb34a6ecf/nihms516334f1.jpg

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