Advanced Drug Delivery Group, Faculty of Pharmacy, University of Sydney, Sydney, NSW, 2006, Australia.
Pharm Res. 2009 Dec;26(12):2639-46. doi: 10.1007/s11095-009-9979-y. Epub 2009 Oct 6.
The capability of the electrostatic next generation impactor (eNGI) has been investigated as a tool capable of measuring the electrostatic charge of single (Flixotide; containing fluticasone propionate (FP)) and combination (Seretide; FP and salmeterol xinafoate (SX)) pressurised metered dose inhalers (pMDIs) at different flow rates.
Aerosol mass distributions were investigated at 30, 60 and 90 l.min(-1) and simultaneous charge measurements recorded.
Analysis of the mass distribution data indicated a flow dependent relationship, where the aerosol performance (aerodynamic diameter <5 mum) of FP significantly increased between 30 l.min(-1) and 60 l.min(-1) for both formulations. No significant increase in SX was observed for Seretide with increased flow rate. Analysis of the charge distribution indicated both formulations to primarily charge negatively with a concurrent increase in charge with increased flow rate. Interestingly, the charge-tomass ratio remained relatively constant between 30 l.min(-1) and 60 l.min(-1) and increased at 90 l.min(-1), indicating that charging was majorly influenced at the highest flow rate.
This study has shown how the eNGI could be used as a simple Pharmacopeia based methodology for the evaluation of mass and charge profiles of single and combination pMDIs at a series of flow rates.
静电下一代撞击器（eNGI）的能力已被研究为一种能够测量单（Flixotide；含丙酸氟替卡松（FP））和组合（Seretide；FP 和沙美特罗辛那酸酯（SX））加压计量吸入器（pMDI）在不同流速下的静电电荷的工具。
在 30、60 和 90 l.min(-1) 下研究了气溶胶质量分布，并同时记录了电荷测量结果。
质量分布数据分析表明存在流速依赖性关系，在两种制剂中，FP 的气溶胶性能（空气动力学直径<5 µm）在 30 l.min(-1) 和 60 l.min(-1) 之间显著增加。随着流速增加，Seretide 中 SX 的增加并不明显。电荷分布分析表明，两种制剂主要带负电荷，随着流速的增加电荷也随之增加。有趣的是，在 30 l.min(-1) 和 60 l.min(-1) 之间，电荷与质量的比值保持相对稳定，而在 90 l.min(-1) 时增加，表明在最高流速下主要受充电影响。
本研究表明，eNGI 如何可作为一种简单的基于药典的方法，用于评估单剂量和组合 pMDI 在一系列流速下的质量和电荷分布。
