Patent ID: 6699508
Filing Date: 2004-03-02
Classification: A61K,A61P

Abstract:
An oral sustained-release preparation containing fasudil hydrochloride as an active ingredient, wherein said fasudil hydrochloride is represented by the following formula: said preparation comprising at least one sustained-release coated particle comprising a core having a surface and a coating formed on the surface of said core, wherein said core contains said active ingredient and said coating comprises a coating base material and an insoluble auxiliary material in the form of a fine powder or fine particles which are pharmaceutically acceptable and insoluble in water and ethanol, said preparation exhibiting, with respect to said active ingredient, the following dissolution rates (1), (2) and (3), as measured by a dissolution test apparatus in conformity with the Japanese Pharmacopoeia Thirteenth Edition under conditions wherein the amount of a dissolution medium is 900 ml, the temperature of the dissolution medium is 37Â±0.5Â° C., and the revolution rate of a paddle is 100Â±4 revolutions per minute: (1) dissolution of 5 to 40% by weight, based on the weight of said active ingredient originally contained in said preparation, at the point in time of 3 hours after the start of the dissolution test, (2) dissolution of 35 to 70% by weight, based on the weight of said active ingredient originally contained in said preparation, at the point in time of 6 hours after the start of the dissolution test, and (3) dissolution of 70% by weight or more, based on the weight of said active ingredient originally contained in said preparation, at the point in time of 15 hours after the start of the dissolution test.