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Fabrication of multiunit controlled-release phenylpropanolamine hydrochloride tablets. Export

Drug Dev Ind Pharm, Vol. 24, No. 8. (August 1998), pp. 793-796.

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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 methacrylate 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.


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