EP0313328A1 — Sustained-release formulations

USPTO Abstract

A granular sustained-release formulation of a pharmacologically active substance presented in the form of a tablet, said tablet comprising sufficient granules to provide a predetermined dose or number of doses of the pharmacologically active substance and effervescent or water-dispersible ingredients, each of said granules having a diameter of preferably between 0.5 and 2.5 mm and comprising: a) a core comprising one or more pharmacologically active substances with preferably one or more excipients; and b) a coating covering substantially the whole surface of the core and comprising 100 parts of a water insoluble but water swellable acrylic polymer and from 20 to 70 parts of a water soluble hydroxylated cellulose derivative, the weight of the coating being from 2 to 25% of the weight of the core. A method for preparing this effervescent or water-dispersible tablet formulation is also provided. Such formulations enable large dosages in sustained-­release form to be more easily administered to patients.