Chemical and Biochemical Engineering, University of Western Ontario, 1151 Richmond Street, London N6A 5B9, Canada.
Int J Pharm. 2012 Jul 15;431(1-2):45-52. doi: 10.1016/j.ijpharm.2012.04.019. Epub 2012 Apr 20.
A novel active and multi-dose dry powder inhaler (DPI) was developed and evaluated to deliver a small quantity (100-500 μg) of pure drug without any excipient. This dry powder inhaler utilized two compressed air flows to dispense and deliver drug powder: the primary flow aerosolizes the drug powder from its pocket and the secondary flow further disperses the aerosol. In vitro tests by Anderson Cascade Impactor (ACI) indicated that the fine particle fraction (FPF) (<4.7 μm) of drug delivery could reach over a range of 50-70% (w/w). Emitted dose tests showed that delivery efficiency was above 85% and its relative standard deviation (RSD) was under 10%. Confocal microscopy was used to confirm the deposition of fluorescently labeled spray-dried powder in rabbit lungs. Also, a chromatographic method was used to quantify drug deposition. The results of animal tests showed that 57% of aerosol deposited in the rabbit lung and 24% deposited in its trachea. All the results implied that this novel active dry powder inhaler could efficiently deliver a small quantity of fine drug particles into the lung with quite high fine particle fraction.
一种新型主动多剂量干粉吸入器(DPI)被开发和评估,用于输送少量(100-500μg)无赋形剂的纯药物。这种干粉吸入器利用两股压缩空气流来分配和输送药物粉末:主气流将药物粉末从其口袋中雾化,次气流进一步分散气溶胶。安德森级联撞击器(ACI)的体外测试表明,药物输送的细颗粒分数(FPF)(<4.7μm)可达到 50-70%(w/w)的范围。发射剂量测试表明,输送效率超过 85%,其相对标准偏差(RSD)低于 10%。共聚焦显微镜用于确认荧光标记喷雾干燥粉末在兔肺中的沉积。此外,还使用了一种色谱方法来定量药物沉积。动物试验的结果表明,气溶胶有 57%沉积在兔子的肺部,24%沉积在气管中。所有结果表明,这种新型主动干粉吸入器可以有效地将少量的细药物颗粒输送到肺部,且具有相当高的细颗粒分数。