Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 104, Issue 8, Pages 2513-2522Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.24503
Keywords
coating; imaging methods; physical characterization; process analytical technology (PAT); quality by design (QBD); tablet; Processing; Unit operations
Funding
- UK Technology Strategy Board [AB293H]
- Engineering and Physical Sciences Research Council [EP/L019922/1]
- Newton Trust Cambridge
- Gonville & Caius College, Cambridge
- EPSRC [EP/L019787/1, EP/L019922/1] Funding Source: UKRI
- Engineering and Physical Sciences Research Council [EP/L019787/1] Funding Source: researchfish
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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
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