NOVELTY - Core-coated tablet complex formulation comprises (a) an inner core containing one or more proton pump inhibitors chosen from esomeprazole, dexlansoprazole, rabeprazole or their salt as an active ingredient, and (b) an outer layer containing mosapride or its salt as an active ingredient. The inner core comprises (i) pre-mixed granules containing excipient excluding lubricant, and (ii) a post-mixing component containing a lubricant and an active ingredient, where outer layer includes an active ingredient, filler, a disintegrant and an additive. The formulation has a double-layer structure including a sustained-release layer containing an active ingredient, a filler, a disintegrant, a release controlling agent and an additive, and an immediate release layer which surrounds all surfaces of the inner core.
USE - The core-coated tablet complex formulation is useful for treating dyspepsia, gastritis, and gastroesophageal reflux disease.
ADVANTAGE - The formulation has excellent stability even when type and content of proton pump inhibitor are changed, and maintains pharmaceutical activities of esomeprazole and mosapride for 24 hours even at a single dosage per day.
DETAILED DESCRIPTION - An INDEPENDENT CLAIM is included for a method for preparing a core-coated tablet complex formulation, which involves (a) preparing the inner core, (b) preparing sustained-release granules and immediate-release granules, (c) filling the immediate-release layer granules into a tableting machine punch die, (d) injecting the inner core into a punch die filled with the immediate-release granules, (e) applying a pre-pressure to the punch die into which the inner core is inserted, (f) filling the sustained-release layer granules in the punch die to which the preload is applied, and (g) tableting while applying main-pressure to the punch die filled with the sustained-release layer granules.
