Patent ID: 8722084
Filing Date: 2014-05-13
Classification: A61K,A61P

Abstract:
1. A capsule comprising: composition (i) comprising a tablet, granule or fine granule in which a release of an active ingredient is controlled; said tablet, granule or fine granule comprising a core particle containing an imidazole compound represented by formula (I′): wherein ring C′ is an optionally substituted benzene ring or an optionally substituted aromatic monocyclic heterocyclic ring, R 0 is a hydrogen atom, an optionally substituted aralkyl group, acyl group or acyloxy group, R 1 , R 2 and R 3 are the same or different and are a hydrogen atom, an optionally substituted alkyl group, an optionally substituted alkoxy group or an optionally substituted amino group, and Y represents a nitrogen atom or CH; or a salt thereof or an optically active isomer thereof as the active ingredient, and a pH-dependently soluble release-controlled coating-layer which comprises one kind of polymeric substance or a mixture of two or more kinds of polymeric substances having different release properties selected from the group consisting of hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, carboxymethylethyl cellulose, methyl methacrylate-methacrylic acid copolymer, methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl acrylate-methyl methacrylate copolymer, hydroxypropyl cellulose acetate succinate, polyvinyl acetate phthalate and shellac, wherein the active ingredient is released at an elution rate of 10% or less for 5 hours in a solution of pH 6.0, and 5% or less for one hour and 60% or more for 8 hours in a solution of pH 6.8, and composition (ii) comprising a tablet, granule or fine granule comprising a core particle containing the active ingredient and enteric coat, such that the active ingredient is released in the pH range of no less than 5.0 to no more than 6.0, wherein the composition (i) and the composition (ii) in the capsule individually contain a sufficient amount of the imidazole compound represented by formula (I′) to raise a plasma level of the imidazole compound represented by formula (I′) in a mammal to whom the capsule is administered to at least 100 ng/ml.