Berg E, Lamb P, Ali A, Dennis J, Tservistas M, Mitchell J
Analytical Development, AstraZeneca R&D, Scheelevägen 2, Lund, S-221 87 Sweden.
Pharmeur Sci Notes. 2008 Feb;2008(1):21-5.
The European Pharmaceutical Aerosol Group (EPAG) has been undertaking a series of investigations in support of developing robust methods for the droplet size analysis of nebuliser-produced aerosols for the proposed European Pharmacopoeia general chapter 2.9.44 covering preparations for nebulisation. The present two-centre study, which was designed to confirm whether or not coating the collection cups of the Next Generation pharmaceutical Impactor (NGI, the recommended impactor for the proposed monograph) is required, forms part of these investigations. The study evaluated NGI-measured aerodynamic droplet-size distributions of aerosols of a generic salbutamol solution for nebulisation generated by two different jet nebulisers. The results demonstrated that there was no indication of biased stage deposition when silicone oil was used to coat the impaction surfaces, as compared to uncoated surfaces. The conclusion was that there is no need to coat the NGI cups when nebulised products are investigated.
欧洲药用气雾剂小组（EPAG）一直在进行一系列调查，以支持为拟议的欧洲药典通则2.9.44（涵盖雾化制剂）开发用于雾化器产生的气雾剂液滴大小分析的可靠方法。目前的这项双中心研究旨在确认是否需要对下一代药用撞击器（NGI，拟议专论中推荐的撞击器）的收集杯进行涂层处理，它是这些调查的一部分。该研究评估了由两种不同的喷射雾化器产生的雾化沙丁胺醇通用溶液气雾剂的NGI测量的空气动力学液滴大小分布。结果表明，与未涂层的表面相比，使用硅油对撞击表面进行涂层时，没有出现阶段沉积偏差的迹象。结论是，在研究雾化产品时，无需对NGI收集杯进行涂层处理。
