Pilcer Gabrielle, Vanderbist Francis, Amighi Karim
Laboratory of Pharmaceutics and Biopharmaceutics, Université Libre de Bruxelles, Boulevard du Triomphe, Brussels, Belgium.
Int J Pharm. 2008 Jun 24;358(1-2):75-81. doi: 10.1016/j.ijpharm.2008.02.014. Epub 2008 Feb 17.
The purpose of the study was to examine the suitability of the Spraytec laser diffraction technique for measuring the size distribution of aerosol particles generated from dry powder inhalators. A range of formulations with different dispersion properties were produced by spray-drying. The percentage of particles below 5.0 microm of these formulations was measured by laser diffraction (Mastersizer 2000 and Spraytec and inertial impaction (MsLI and NGI) using various inhaler devices and at different flow rates between 30 and 100 l/min. Linear relationships and correlations (R(2)>0.9) existed between the results obtained from, on one hand, the Mastersizer 2000 and the Spraytec, and, on the other hand, the MsLI and the Spraytec regardless of flow rates and inhaler devices. The Spraytec could be a reliable technique for the development, evaluation and quality control of dry powder aerosol formulations.
本研究的目的是考察Spraytec激光衍射技术用于测量干粉吸入器产生的气溶胶颗粒尺寸分布的适用性。通过喷雾干燥制备了一系列具有不同分散特性的制剂。使用各种吸入装置并在30至100升/分钟的不同流速下，通过激光衍射（Mastersizer 2000和Spraytec）和惯性撞击（MsLI和NGI）测量这些制剂中粒径小于5.0微米的颗粒百分比。一方面，Mastersizer 2000和Spraytec所得结果之间，另一方面，MsLI和Spraytec所得结果之间，无论流速和吸入装置如何，均存在线性关系和相关性（R²>0.9）。Spraytec可能是一种用于干粉气雾剂制剂研发、评估和质量控制的可靠技术。
