Application of Powder-Layering Technology and Film Coating for Manufacture of Sustained-Release Pellets Using a Rotary Fluid Bed Processor

Abstract The main objective of this study was to prepare pellets in a Roto-processor using the powder-layering process onto inert nonpareils and to evaluate the applicability of the Roto-processor setup for film coating. Nonpareils were loaded with phenylpropanolamine hydrochloride and coated with ethyl cellulose polymeric dispersion (Surelease®). The drug loading was analyzed to test the eficiency 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 for powder layering were greater than 90%. The dissolution studies on the Blm-coated pellets showed sustained release over a 10-hr period. The time required for 50% of drug release increased and the mean pore diameter decreased with an increase in polymer coating.