268605 Understanding Thermodynamics of Aqueous Film Coating Process Using Data Logger

Tuesday, October 30, 2012: 1:00 PM
Shadyside (Omni )
Ganeshkumar A. Subramanian, Drug Product Science and Technology, Bristol Myers Squibb, New Brunswick, NJ

Understanding Thermodynamics of Aqueous Film Coating Process Using Data Logger

Authors: G. Subramanian, P. Pandey, S. Gour, D. Bindra, S. Badawy

Abstract:

Pharmaceutical film coating process is typically monitored by inlet and exhaust condition of temperature and humidity with measurement devices located outside the coating pan. Current configurations of coating pans do not allow continuous measurement of the temperature and humidity within the tablet bed.  Vast differences in heat and mass transfer efficiencies across different coating pan sizes can result in differences in drying and film forming dynamics across various coating pans at the same outlet temperature and humidity. Similarly, different local temperature and humidity conditions (and hence film forming dynamics) can be expected for coating operations carried out at same exhaust temperature, if such temperature is achieved by different means such as changing inlet air volume, air temperature, suspension spray rate or suspension solids concentration. Considerable insight into the dynamics of the coating process can be gained by using data loggers that can be incorporated in the tablet bed and placed such that they can collect temperature and humidity conditions in the tablet bed continuously. A design of experiments (DOE) with coating process performed at various macro-environmental conditions was carried out to determine their effects on the local-environmental thermodynamics in the tablet bed. The data collected from the data loggers enabled correlation between the changes to the macro-environment with changes in the local environment temperature and humidity in the tablet bed. Data from the data logger was used to develop a simple thermodynamic model based on heat and mass balance at different coating conditions across different pan sizes.


Extended Abstract: File Not Uploaded
See more of this Session: Process Robustness in Pharmaceutical Manufacturing
See more of this Group/Topical: Process Development Division