Patent ID: 8871273
Filing Date: 2014-10-28
Classification: A61J,A61K,A61P,B01J

Abstract:
1. A coated granule comprising a biologically active substance, obtained by a method that comprises steps of: (a) providing a granule comprising the biologically active substance and low substituted hydroxypropyl cellulose, wherein the biologically active substance is a benzimidazole proton pump inhibitor, (b) coating the granule comprising the biologically active substance with a coating material comprising a polymer base selected from the group consisting of low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, methyl cellulose, and hydroxyethylmethyl cellulose, so as to provide an intermediate coating layer on the granule (c) coating the granule obtained in the step (b) with a coating material comprising a mixture of two or more kinds of polymers selected from the group consisting of methyl methacrylate methacrylic acid copolymers, so as to provide a controlled release coating film on the granule, and (d) heating the granule comprising the biologically active substance to a temperature about 50° C. or higher, and then maintaining the granule heated at the temperature for about 1 minute to about 1 hour, wherein the heating step is performed during the step (a), or during, before, or after the step (b) or the step (c), wherein the coated granule dissolves or elutes the biologically active substance, pH-dependently; and controls a release of the biologically active substance from the coated granule depending on pH to which the coated granule is exposed.