Hoe Susan, Traini Daniela, Chan Hak-Kim, Young Paul M
Advanced Drug Delivery Group, Faculty of Pharmacy (A15), University of Sydney, Sydney, NSW 2006, Australia.
Eur J Pharm Sci. 2009 Sep 10;38(2):88-94. doi: 10.1016/j.ejps.2009.06.003. Epub 2009 Jun 24.
The electrical Next Generation Impactor (eNGI) was assessed against the electrical low-pressure impactor (ELPI) and next generation impactor (NGI) for its capability to characterise particle size and electrostatic charge properties of dry powder inhaler (DPI) formulations. Following assessment, the relationship between inhalational air flow rate and drug powder charge was explored using the eNGI. At a vacuum flow rate of 30L/min, doses of Pulmicort (budesonide 400 microg) and Bricanyl (terbutaline 500 microg) were dispersed into the ELPI, NGI and eNGI, from which particle size profiles and charge profiles were ascertained. Further doses of Pulmicort and Bricanyl were fired into the eNGI at vacuum air flow rates of 45, 60, 75 and 90 L/min, and the resultant size and charge profiles were determined. Particle size profiles at 30 L/min were found to be comparable between the NGI and eNGI, while charge profiles were comparable between the eNGI and ELPI. As air flow rate increased from 30 to 90 L/min, in vitro aerosol performance improved before reaching a peak at 45 L/min (Pulmicort) and 60 L/min (Bricanyl). Net charge also increased with flow rate, the cause of which may be a combination of increased turbulence and aerosol performance. This study demonstrates that the eNGI is capable of electrostatic and particle size characterization of commercial drug-only DPI products.
对电子下一代撞击器(eNGI)进行了评估,将其与电子低压撞击器(ELPI)和下一代撞击器(NGI)进行比较,以确定其对干粉吸入器(DPI)制剂的粒径和静电荷特性进行表征的能力。评估后,使用eNGI探讨了吸入气流速率与药物粉末电荷之间的关系。在30L/min的真空流速下,将普米克(布地奈德400微克)和博利康尼(特布他林500微克)的剂量分散到ELPI、NGI和eNGI中,从中确定粒径分布和电荷分布。将更多剂量的普米克和博利康尼以45、60、75和90L/min的真空气流速率喷射到eNGI中,并确定所得的粒径和电荷分布。发现在30L/min时,NGI和eNGI之间的粒径分布具有可比性,而eNGI和ELPI之间的电荷分布具有可比性。随着气流速率从30L/min增加到90L/min,体外气溶胶性能在达到45L/min(普米克)和60L/min(博利康尼)的峰值之前有所改善。净电荷也随着流速增加,其原因可能是湍流增加和气溶胶性能提高的综合作用。这项研究表明,eNGI能够对仅含药物的商用DPI产品进行静电和粒径表征。