EP0653935B1 — Pelletised pharmaceutical composition

USPTO Abstract

A pelletized sustained release pharmaceutical composition including a core element including approximately 0.1 to 95% by weight, based on the total weight of the core element, of an active ingredient of low aqueous solubility; approximately 0.1 to 55% by weight of a core seed; and a core coating for the core element, including approximately 30 to 97% by weight, based on the total weight of the core coating, excluding filler, of an enteric polymer; approximately 3 to 50% by weight of an insoluble polymer; and 0 to approximately 50% by weight of plasticizer, the enteric polymer comprising at least approximately 70% by weight of the total weight of the enteric polymer and insoluble polymer; the core coating being such that the active ingredient is released in a controlled fashion over an extended period in the intestine but substantially no release occurs in the acid environment of the stomach and blood levels of active ingredient are maintained within the therapeutic range over an extended period of time.