Understanding the thermodynamic micro-environment inside a pan coater using a data logging device. (April 2014)

• Record Type: Journal Article
• Authors: Pandey, Preetanshu; Ji, Jiangning; Subramanian, Ganeshkumar; Gour, Shruti; Bindra, Dilbir S.
• Is Part Of: Drug development and industrial pharmacy. Volume 40:Number 4(2014:Apr.)
• Page Start: 542
• Page End: 548
• Publication Date: 2014-04
• Subjects: Pharmaceutical chemistry -- Periodicals; Pharmaceutical industry -- Periodicals; Drug Industry -- Periodicals; Technology, Pharmaceutical -- Periodicals; 615.05
• DOI: 10.3109/03639045.2013.772192
• Languages: English
• ISSNs: 0363-9045

Abstract

<abstract> <title>Abstract</title> <p> <italic>Objective</italic>: The objective of the current study was to establish the use of PyroButton data-logging device to monitor and quantify the thermodynamic environment (temperature and humidity) of a pan coating process.</p> <p> <italic>Material and methods</italic>: PyroButtons were placed (fixed) at various locations in a pan coater, including exhaust plenum, spray-gun bar, baffles and were also allowed to freely move with the tablet-bed. A full factorial design of experiments (DOE) study on three process parameters, exhaust temperature, pan speed and spray rate was conducted on a 24 inch pan coater, using a coating system and a core tablet combination expected to have a narrow process operating space.</p> <p> <italic>Results</italic>: It was shown that the PyroButtons can provide a detailed and useful signature of the coating process. PyroButton data showed that the tablet-bed temperature was always lower than exhaust temperature and that the difference was a function of the operating conditions such as spray rate. Similarly, the tablet-bed humidity was found to always be higher than exhaust humidity. Some of the DOE batches showed coating defects (logo-bridging). It was shown that the relative humidity (RH), as measured by the freely-moving PyroButtons in the tablet-bed, correlated well with the logo-bridging events. A critical RH value (30%) was established, above which logo-bridging was observed for the selected formulation.</p> <p> <italic>Conclusions</italic>: This study showed that PyroButtons can provide very meaningful micro-environmental data that can be correlated to coating defects, and can aid in establishing a process design space for a given coating and tablet formulation.</p> </abstract>