Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätstr. 1, 40225 Düsseldorf, Germany.
Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia.
Int J Pharm. 2017 Nov 30;533(2):377-382. doi: 10.1016/j.ijpharm.2017.06.016. Epub 2017 Jun 9.
A fast method for pellet coating uniformity analysis, using a commercial computer scanner was developed. The analysis of the individual particle coating thicknesses was based on using a transparent orange colored coating layer deposited on white pellet cores. Besides the analysis of the coating thickness the information of pellet size and shape was obtained as well. Particle size dependent coating thickness and particle size independent coating variability was calculated by combining the information of coating thickness and pellet size. Decoupling coating thickness variation sources is unique to presented method. For each coating experiment around 10000 pellets were analyzed, giving results with a high statistical confidence. Proposed method was employed for the performance evaluation of classical Wurster and swirl enhanced Wurster coater operated at different gap settings and air flow rates.
一种快速的颗粒包衣均匀性分析方法,使用商业计算机扫描仪进行开发。通过使用涂覆在白色丸芯上的透明橙色涂层来分析各个颗粒的涂层厚度。除了分析涂层厚度外,还获得了丸粒大小和形状的信息。通过将涂层厚度和丸粒大小的信息相结合,计算了与颗粒大小相关的涂层厚度和与颗粒大小无关的涂层可变性。这种方法独特之处在于能够解耦涂层厚度变化的来源。对于每个包衣实验,大约分析了 10000 个丸粒,结果具有很高的统计置信度。该方法用于评估在不同间隙设置和空气流速下运行的经典 Wurster 和旋流增强 Wurster 包衣机的性能。