Development of an automation system for a tablet coater |
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Authors: | Mirja Ruotsalainen Jyrki Hein?m?ki Jukka Rantanen Jouko Yliruusi |
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Institution: | (1) Pharmaceutical Technology Division, University of Helsinki, Finland;(2) Viikki Drug Discovery Technology Center, University of Helsinki, Finland;(3) Department of Pharmacy, Pharmaceutical Technology Division, University of Helsinki, P.O. Box 56, FIN-00014, Finland |
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Abstract: | An instrumentation and automation system for a side-vented pan coater with a novel air-flow rate measurement system for monitoring
the film-coating process of tablets was designed and tested. The instrumented coating system was tested and validated by film-coating
over 20 pilot-scale batches of tablets with aqueous-based hydroxypropyl methylcellulose (HPMC). Thirteen different process
parameters were continuously measured and monitored, and the most significant ones were logged for analysis. Laser profilometry
was used to measure the surface roughness of the coated tablets. The instrumentation system provided comprehensive and quantitative
information on the process parameters monitored. The measured process parameters and the responses of the film-coated tablet
batches showed that the coating process is reproducible. The inlet air-flow rate influenced the coating process and the subsequent
quality of the coated tablets. Increasing the inlet flow rate accelerated the drying of the tablet surface. At high inlet
flow rate, obvious film-coating defects (ie, unacceptable surface roughness of the coated tablets) were observed and the loss
of coating material increased. The instrumented and automated pancoating system described, including historical data storage
capability and a novel air-flow measurement system, is a useful tool for controlling and characterizing the tablet film-coating
process. Monitoring of critical process parameters increases the overall coating process efficiency and predictability. |
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Keywords: | film coating instrumentation process automation reproducibility process parameters air flow rate |
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