SUSTAINED RELEASE DELIVERY OF HIGHLY WATER-SOLUBLE COMPOUNDS

摘要

The invention is an oral pharmaceutical composition comprising a) a tablet core comprising a therapeutically effective amount of a water-soluble active ingredient, or a phamaceutically acceptable salt thereof, a water swellable polymer capable of swelling upon hydration, and a neutralizing agent which modulates hydration and provides for release of the active ingredient from the tablet core into the gastrointestinal tract by extrusion of swelling polymer, said swelling polymer containing the active ingredient, from the core, and b) a water insoluble film coating material surrounding the tablet, wherein the composition has a plurality of apertures which provide a means for the active ingredient to leave the core unimpeded by the film wherein the composition facilitates controlled dual release of the active ingredient from the tablet core into the gastrointestinal tract by diffusion directly from the core and by extrusion of swelling polymer from the core.