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相对湿度对干粉吸入器气雾剂静电荷特性的影响。

Effect of relative humidity on the electrostatic charge properties of dry powder inhaler aerosols.

作者信息

Kwok Philip Chi Lip, Chan Hak-Kim

机构信息

University of Sydney, Building A15, Sydney, NSW 2006, Australia.

出版信息

Pharm Res. 2008 Feb;25(2):277-88. doi: 10.1007/s11095-007-9377-2. Epub 2007 Jul 10.

Abstract

PURPOSE

At present, there is no published data examining the effect of relative humidity on the electrostatic charges of dry powder inhaler aerosols. The charging behaviour of two commercial products, Pulmicort and Bricanyl Turbuhalers, were investigated using an electrical low pressure impactor (ELPI).

METHODS

ELPI was successfully modified to disperse the aerosols at 60 l/min. Four doses from each new inhaler were sampled at 15, 40, 65, and 90% RH. Particles deposited on the impactor stages according to their aerodynamic diameters and their charges were measured simultaneously by the electrometers. The drug in each size fraction was quantified using HPLC.

RESULTS

Both products generated bipolar charges. The charging behaviour of the two types of inhaler showed different humidity dependence although the mass output was not significantly affected. The absolute specific charge of budesonide fine particles from Pulmicort was the lowest at 40% RH but increased at lower and higher RHs. In contrast, the terbutaline sulfate fine particles from Bricanyl followed the expected trend of charge reduction with increasing RH.

CONCLUSIONS

The distinct trends of charging of aerosols from Pulmicort and Bricanyl Turbuhalers was explained by differences in hygroscopicity and other physicochemical factors between the two drugs.

摘要

目的

目前,尚无已发表的数据研究相对湿度对干粉吸入器气溶胶静电荷的影响。使用低压冲击器(ELPI)研究了两种商业产品(普米克和博利康尼都保)的充电行为。

方法

成功对ELPI进行了改进,使其能以60升/分钟的速度分散气溶胶。在相对湿度为15%、40%、65%和90%的条件下,对每个新吸入器的四剂药物进行采样。根据颗粒的空气动力学直径,沉积在冲击器级上的颗粒及其电荷由静电计同时测量。使用高效液相色谱法对每个粒径级分中的药物进行定量。

结果

两种产品均产生双极性电荷。尽管质量输出没有受到显著影响,但两种吸入器的充电行为表现出不同的湿度依赖性。普米克中布地奈德细颗粒的绝对比电荷在相对湿度为40%时最低,但在较低和较高相对湿度下均增加。相比之下,博利康尼中的硫酸特布他林细颗粒随着相对湿度的增加呈现出预期的电荷减少趋势。

结论

普米克和博利康尼都保气溶胶充电的不同趋势是由两种药物在吸湿性和其他物理化学因素上的差异所解释的。

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