An evaluation of process parameters to improve coating efficiency of an active tablet film-coating process

被引:43
作者
Wang, Jennifer [1 ]
Hemenway, Jeffrey [1 ]
Chen, Wei [1 ]
Desai, Divyakant [1 ]
Early, William [1 ]
Paruchuri, Srinivasa [1 ]
Chang, Shih-Ying [1 ]
Stamato, Howard [1 ]
Varia, Sailesh [1 ]
机构
[1] Bristol Myers Squibb Co, Drug Prod Sci & Technol, New Brunswick, NJ 08903 USA
关键词
Active film-coating; Coating efficiency; Perforated pan coater; Multivariate analysis; Computational fluid dynamics; UNIFORMITY;
D O I
10.1016/j.ijpharm.2012.01.033
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Effects of material and manufacturing process parameters on the efficiency of an aqueous active tablet film-coating process in a perforated pan coater were evaluated. Twenty-four batches representing various core tablet weights, sizes, and shapes were coated at the 350-500 kg scale. The coating process efficiency, defined as the ratio of the amount of active deposited on tablet cores to the amount of active sprayed, ranged from 86 to 99%. Droplet size and velocity of the coating spray were important for an efficient coating process. Factors governing them such as high ratios of the suspension spray rate to atomization air flow rate, suspension spray rate to pattern air flow rate, or atomization air flow rate to pattern air flow rate improved the coating efficiency. Computational fluid dynamics modeling of the droplets showed that reducing the fraction of the smaller droplets, especially those smaller than 10 mu m, resulted in a marked improvement in the coating efficiency. Other material and process variables such as coating suspension solids concentration, pan speed, tablet velocity, exhaust air temperature, and the length of coating time did not affect the coating efficiency profoundly over the ranges examined here. (C) 2012 Elsevier B.V. All rights reserved.
引用
收藏
页码:163 / 169
页数:7
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