Chow Keat Theng, Zhu Kewu, Tan Reginald B H, Heng Paul W S
Institute of Chemical and Engineering Sciences, Jurong Island, Singapore, Singapore.
Pharm Res. 2008 Dec;25(12):2822-34. doi: 10.1007/s11095-008-9651-y. Epub 2008 Jun 26.
This study aims to elucidate the electrostatic behavior of a model lactose carrier used in dry powder inhaler formulations by examining the effects of ambient relative humidity (RH), aerosolization air flow rate, repeated inhaler use, gelatin capsule and tapping on the specific charge (nC/g) of bulk and aerosolized lactose.
Static and dynamic electrostatic charge measurements were performed using a Faraday cage connected to an electrometer. Experiments were conducted inside a walk-in environmental chamber at 25 degrees C and RHs of 20% to 80%. Aerosolization was achieved using air flow rates of 30, 45, 60 and 75 L/min.
The initial charges of the bulk and capsulated lactose were a magnitude lower than the charges of tapped or aerosolized lactose. Dynamic charge increased linearly with aerosolization air flow rate and RH. Greater frictional forces at higher air flow rate induced higher electrostatic charges. Increased RH enhanced charge generation. Repeated inhaler use significantly influenced electrostatic charge due to repeated usage.
This study demonstrated the significance of interacting influences by variables commonly encountered in the use DPI such as variation in patient's inspiratory flow rate, ambient RH and repeated inhaler use on the electrostatic behavior of a lactose DPI carrier.
本研究旨在通过考察环境相对湿度(RH)、雾化气流速率、吸入器重复使用、明胶胶囊和敲击对散装和雾化乳糖比电荷(nC/g)的影响,阐明用于干粉吸入剂配方的模型乳糖载体的静电行为。
使用连接到静电计的法拉第笼进行静态和动态静电荷测量。实验在步入式环境试验箱内于25℃和20%至80%的相对湿度下进行。使用30、45、60和75 L/min的气流速率实现雾化。
散装和胶囊化乳糖的初始电荷比敲击或雾化乳糖的电荷低一个数量级。动态电荷随雾化气流速率和相对湿度呈线性增加。较高气流速率下更大的摩擦力导致更高的静电荷。相对湿度增加会增强电荷产生。吸入器重复使用由于反复使用而显著影响静电荷。
本研究证明了在使用干粉吸入器时常见的变量(如患者吸气流量变化、环境相对湿度和吸入器重复使用)对乳糖干粉吸入剂载体静电行为的相互作用影响的重要性。