A new process control strategy for aqueous film coating of pellets in fluidised bed.
The parameters with effect on maximum spray rate and maximum relative outlet air humidity when coating pellets in a fluidised bed were investigated. The tested variables include type of water based modified release film coating (Eudragit NE 30D, Eudragit RS 30D, Aquacoat ECD) coating principle (top spray, bottom spray), inlet air humidity and type of pellets (sugar spheres, microcrystalline cellulose pellets). The maximum spray rate was not influenced by the coating principles. The highest spray rate was obtained for the film polymer with the lowest tackiness which is assumed to be the controlling factor. The type of pellets affected the maximum spray rate. A thermodynamic model for the coating process is employed throughout the process and not just during steady state. The thermodynamic model is incorporated into a new process control strategy. The process control strategy is based on in-process calculation of degree of utilisation of the potential evaporation energy (DUE) of the outlet air and the relative outlet air humidity (RH). The spray rate is maximised using set points of DUE and RH as control parameters. The product temperature is controlled simultaneously by regulating the inlet air temperature.
Larsen
Crilles C
CC
Process Technology Development, Ferring A/S, Indertoften 10, DK-2720 Vanløse, Denmark. crilles.casper.larsen@ferring.com
Sonnergaard
Jørn M
JM
Bertelsen
Poul
P
Holm
Per
P
D004343:Drug Implants / Q000138:chemical synthesis*; D011108:Polymers / Q000138:chemical synthesis*; D011109:Polymethacrylic Acids / Q000138:chemical synthesis; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D013816:Thermodynamics
D004343:Drug Implants; D011108:Polymers; D011109:Polymethacrylic Acids; C038300:methylmethacrylate-methacrylic acid copolymer