Characterization of a Hot-Melt Fluid Bed Coating Process for Fine Granules

Characterization of a Hot-Melt Fluid Bed Coating Process for Fine Granules
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DOI:
10.1023/a:1015972007342
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发表时间:
1990-11
影响因子:
3.7
通讯作者:
M. Jozwiakowski;David M. Jones;R. M. Franz
M. Jozwiakowski;David M. Jones;R. M. Franz
中科院分区:
医学3区
文献类型:
--
作者:
M. Jozwiakowski;David M. Jones;R. M. Franz

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综述了在流化床造粒机中进行热熔颗粒包覆所必需的设备改造和工艺变化。提出了将部分氢化棉籽油涂覆在由疏水药物和蔗糖组成的细颗粒(平均粒径为77 μ m,范围为10 - 150 μ m,一个标准差为10 μ m)上的具体案例。主要变量是产品床层温度,蜡的温度,喷雾速度和雾化空气压力。选择产物床温度为最佳凝结速率,并通过统计设计实验对后三个变量进行了变化。考察了不同工艺变量组合制备的蜡包颗粒的物理性能。响应面分析用于确定最佳工艺设置在溶解,颗粒大小,和密度的涂层产品。实验证明,该系统完全适合于均匀包覆颗粒的生产,在雾化空气120°C,熔融包覆温度,喷雾速度为30 g/min,雾化空气压力为5 bar的优化条件下,可获得最佳产品。
The equipment modifications and process changes necessary to perform hot-melt particle coating in a fluid bed granulator are reviewed. A specific case is presented in which partially hydrogenated cottonseed oil is coated onto fine granules (mean particle size, 77 µm; range, 10–150 µm; one standard deviation is 10 µm) composed of a hydrophobic drug and sucrose. The major variables were product bed temperature, temperature of the wax, spray rate, and atomization air pressure. The product bed temperature was selected to give the optimum congealing rate, and the latter three variables were varied in a statistically designed experiment. The physical properties of wax-coated granules fabricated using combinations of process variables were examined. Response surface analysis was used to determine the optimum process settings in terms of dissolution, particle size, and density of the coated product. This system proved quite adequate for the production of uniformly coated granules, with the best product being obtained at the optimized conditions using 120°C atomization air and molten coating temperature, 30 g/min as the spray rate, and an atomization air pressure of 5 bar.