Impact of Processing Conditions on Inter-tablet Coating Thickness Variations Measured by Terahertz In-Line Sensing

被引:37
|
作者
Lin, Hungyen [1 ]
May, Robert K. [1 ]
Evans, Michael J. [2 ]
Zhong, Shuncong [3 ]
Gladden, Lynn F. [1 ]
Shen, Yaochun [3 ]
Zeitler, J. Axel [1 ]
机构
[1] Univ Cambridge, Dept Chem Engn & Biotechnol, Cambridge CB2 3RA, England
[2] TeraView Ltd, Cambridge CB4 0DS, England
[3] Univ Liverpool, Dept Elect Engn & Elect, Liverpool L69 3GJ, Merseyside, England
基金
英国工程与自然科学研究理事会;
关键词
coating; imaging methods; physical characterization; process analytical technology (PAT); quality by design (QBD); tablet; Processing; Unit operations; UNIFORMITY; TIME;
D O I
10.1002/jps.24503
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
A novel in-line technique utilising pulsed terahertz radiation for direct measurement of the film coating thickness of individual tablets during the coating process was previously developed and demonstrated on a production-scale coater. Here, we use this technique to monitor the evolution of tablet film coating thickness and its inter-tablet variability during the coating process under a number of different process conditions that have been purposefully induced in the production-scale coating process. The changes that were introduced to the coating process include removing the baffles from the coater, adding uncoated tablets to the running process, halting the drum, blockage of spray guns and changes to the spray rate. The terahertz sensor was able to pick up the resulting changes in average coating thickness in the coating drum and we report the impact of these process changes on the resulting coating quality. (c) 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:2513-2522, 2015
引用
收藏
页码:2513 / 2522
页数:10
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