Amorphous body composed of heterocyclic compound, solid dispersion and pharmaceutical preparation each comprising the same, and process for production of the same

A method for producing an amorphous body composed of a heterocyclic compound represented by general formula (I):

• wherein, X represents a nitrogen atom or CH;
• R1 and R2, both or either one, represent a hydrogen atom, a hydroxyl group, a halogen, an amino group, a C1-C6 alkylamino group, a C1-C6 alkoxy group, a C1-C6 alkyl group, or a cyano group;
• R3 represents a hydrogen atom, a difluoromethyl group, an amino group, a C1-C6 alkylamino group, a methyl, or a hydroxymethyl group;
• R4 and R5 represent a hydrogen atom or a C1-C6 alkyl group;
• and
• R6 represents a morpholino, optionally substituted with 1 to 2 C1-C6 alkyl groups, a pyrrolidinyl, optionally substituted with a hydroxy C1-C6 alkyl group, a piperidino, optionally substituted with 1 to 2 oxygen atoms, a hydroxyl group, a formyl, or a C1-C6 alkyl group, piperazinyl, optionally substituted with 1 to 2 oxygen atoms, the nitrogen at position 4 optionally substituted with a substituent selected from the group consisting of formyl, hydroxyl C1-C6 alkyl, C1-C6 alkoxycarbonyl, oxo C1-C6 alkyl, aromatic carbonyl, benzylcarbonyl and substituted carbamoyl, or a 1,4-diazepano, optionally substituted with 1 to 2 oxygen atoms, the nitrogen at position 4 optionally substituted with a substituent selected from the group consisting of formyl, hydroxy C1-C6 alkyl, C1-C6 alkoxycarbonyl, oxo C1-C6 alkyl, aromatic carbonyl, benzyl carbonyl and substituted carbamoyl;
• or a hydrate thereof, a solvate thereof, or a pharmaceutically acceptable salt thereof;
• said method comprising dissolving said heterocyclic compound, the hydrate thereof, the solvate thereof or the pharmaceutically acceptable salt thereof in a solvent to prepare a feed solution;
• spraying said feed solution;
• and
• drying the sprayed feed solution to obtain said amorphous body.