Fabrication of Multiunit Controlled-Release Phenylpropanolamine Hydrochloride Tablets

Abstract

Phenylpropanolamine hydrochloride (PPA) pellets were prepared in a fluidized-bed rotary granulator. Microcrystalline cellulose and distilled water were used as pelletization enhancer and binder, respectively. The pellets were coated with methacry-late ester copolymer (Eudragit® RS 100) solution containing a 1:1 ratio mixture of triethyl citrate and castor oil as plasticizers. The addition of approximately 30% microcrystalline cellulose and 2% croscarmellose sodium to the 50% coated pellets produced fast disintegrating tablets. Dissolution profiles of both pellets and their respective matrix tablets were comparable and conformed to the USP dissolution requirement for PPA extended-release capsules.