An evaluation of process parameters to improve coating efficiency of an active tablet film-coating process.
Effects of material and manufacturing process parameters on the efficiency of an aqueous active tablet film-coating process in a perforated pan coater were evaluated. Twenty-four batches representing various core tablet weights, sizes, and shapes were coated at the 350-500 kg scale. The coating process efficiency, defined as the ratio of the amount of active deposited on tablet cores to the amount of active sprayed, ranged from 86 to 99%. Droplet size and velocity of the coating spray were important for an efficient coating process. Factors governing them such as high ratios of the suspension spray rate to atomization air flow rate, suspension spray rate to pattern air flow rate, or atomization air flow rate to pattern air flow rate improved the coating efficiency. Computational fluid dynamics modeling of the droplets showed that reducing the fraction of the smaller droplets, especially those smaller than 10 μm, resulted in a marked improvement in the coating efficiency. Other material and process variables such as coating suspension solids concentration, pan speed, tablet velocity, exhaust air temperature, and the length of coating time did not affect the coating efficiency profoundly over the ranges examined here.
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ 08903, United States. jennifer.wang@bms.com
Jennifer
J
Wang
Jeffrey
J
Hemenway
Wei
W
Chen
Divyakant
D
Desai
William
W
Early
Srinivasa
S
Paruchuri
Shih-Ying
SY
Chang
Howard
H
Stamato
Sailesh
S
Varia
D002214:Capsules; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods; D004777:Environment; D005079:Excipients; D011108:Polymers; D013499:Surface Properties; D013535:Suspensions; D013608:Tablets, Enteric-Coated; D013678:Technology, Pharmaceutical / Q000379:methods
D002214:Capsules; D005079:Excipients; D011108:Polymers; D013535:Suspensions; D013608:Tablets, Enteric-Coated