title: Real-time monitoring of thermodynamic microenvironment in a pan coater.
abstract: The current study demonstrates the use of tablet-size data logging devices (PyroButtons) to quantify the microenvironment experienced by tablets during pan coating process. PyroButtons were fixed at the inlet and exhaust plenums, and were also placed to freely move with the tablets. The effects of process parameters (spray rate and inlet-air humidity) on the thermodynamic conditions inside the pan coater were studied. It was shown that the same exhaust temperature (a parameter most commonly monitored and controlled during film coating) can be attained with very different tablet-bed conditions. The tablet-bed conditions were found to be more sensitive to the changes in spray rate as compared with the inlet-air humidity. Both spray rate and inlet-air humidity were shown to have an effect on the number of tablet defects (loss of logo definition), and a good correlation between number of tablet defects and tablet-bed humidity was observed. The ability to quantify the thermodynamic microenvironment experienced by the tablets during coating and be able to correlate that to macroscopic tablet defects can be an invaluable tool that can help to establish a process design space during product development.
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey 08901, USA. preetanshu.pandey@bms.com
authors.forename: Preetanshu
authors.initials: P
authors.lastname: Pandey
authors.forename: Dilbir S
authors.initials: DS
authors.lastname: Bindra
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D003199:Computer Systems; D013608:Tablets, Enteric-Coated / Q000737:chemistry*; D013816:Thermodynamics
chemical_list: D013608:Tablets, Enteric-Coated