Development of an automation system for a tablet coater.
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 pan-coating 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.
Ruotsalainen
Mirja
M
Pharmaceutical Technology Division, University of Helsinki, Finland. mirja.ruotsalainen@helsinki.fi
Heinämäki
Jyrki
J
Rantanen
Jukka
J
Yliruusi
Jouko
J
D001331:Automation; D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004339:Drug Compounding / Q000379:methods / Q000592:standards; D004780:Environment, Controlled; D006245:Hardness Tests / Q000592:standards; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis / Q000592:standards; D015203:Reproducibility of Results; D013499:Surface Properties; D013608:Tablets, Enteric-Coated / Q000378:metabolism*; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods*
D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated