APPLICATION OF POWDER-LAYERING TECHNOLOGY AND FILM COATING FOR MANUFACTURE OF SUSTAINED-RELEASE PELLETS USING A ROTARY FLUID-BED PROCESSOR

The main objective of this study was to prepare pellets in a Roto-proc essor using the powder-layering process onto inert nonpareils and to e valuate the applicability of the Roto-processor setup for film coating . Nonpareils were loaded with phenylpropanolamine hydrochloride and fi lm coated with ethyl cellulose polymeric dispersion (Surelease(R)). Th e drug loading was analyzed to test the efficiency of powder layering. The effect of polymer level on the drug release from the pellets and the pore size distribution in the membrane were studied. The yields fo r powder layering were greater than 90%. The dissolution studies on th e film-coated pellets showed sustained release over a 10-hr period. Th e time required for 50% of drug release increased and the mean pore di ameter decreased with an increase in polymer coating.