Division of Pharmaceutical Technology, University of Hamburg, Bundesstraße 45, 20146 Hamburg, Germany.
Fette Compacting GmbH, Grabauer Strasse 24, 21493 Schwarzenbek, Germany.
Int J Pharm. 2019 Jan 30;555:220-227. doi: 10.1016/j.ijpharm.2018.11.017. Epub 2018 Nov 9.
The present study focused on the effect of different feed frame components on the residence time distribution of a three-chamber feed frame system (Fill-O-Matic). A production-scale rotary tablet press was used to simulate the industrial manufacture of tablets. The powder residence time distribution was used to characterize the powder behavior in the Fill-O-Matic. Therefore, two powder blends based on microcrystalline cellulose, one of them serving as a plain powder blend (MCC blend) and the other blend (tracer blend) spray colored with an indigo carmine solution by a fluid bed granulator, were used. With these powder blends, the effect of the reduction of the Fill-O-Matic volume with a perspex disc on the residence time distribution was compared with the standard configuration of the Fill-O-Matic. Furthermore, the filling wheel design with regard to the rod shape and different gap size configurations between the feed frame and the die disc were investigated. Interestingly, the reduction of the feed frame volume led to a remarkable decrease of the mean residence time and the mean centered variance. Moreover, the results of the filling wheel design showed that the rod shape of the filling wheels had a high influence on the intermixing of the powder particles in the filling chamber, whereas the corresponding tablet weights and their relative standard deviation were not affected. The gap size between the feed frame and the die disc had low influence on the residence time distribution but an effect on the tablet weights and their standard deviation.
本研究主要关注不同给料器组件对三室给料器系统(Fill-O-Matic)停留时间分布的影响。采用生产规模的旋转压片机模拟工业规模的片剂制造。通过粉末停留时间分布来描述 Fill-O-Matic 中粉末的行为。因此,使用了两种基于微晶纤维素的粉末混合物,一种是普通粉末混合物(MCC 混合物),另一种是通过流化床造粒机喷涂靛蓝胭脂红溶液的示踪剂混合物。使用这些粉末混合物,比较了使用有机玻璃圆盘减小 Fill-O-Matic 体积对停留时间分布的影响与 Fill-O-Matic 的标准配置。此外,还研究了装料轮的设计,包括装料轮的杆形和给料器与模孔盘之间的不同间隙尺寸配置。有趣的是,给料器体积的减小导致平均停留时间和平均中心方差显著降低。此外,装料轮设计的结果表明,装料轮的杆形对装料室中粉末颗粒的混合有很大的影响,而相应的片剂重量及其相对标准偏差不受影响。给料器与模孔盘之间的间隙尺寸对停留时间分布的影响较小,但对片剂重量及其标准偏差有影响。