QUINOLINE DERIVATIVE-CONTAINING PHARMACEUTICAL COMPOSITION
A pharmaceutical composition comprising a compound represented by the formula (I) or pharmaceutically acceptable salt thereof or solvate thereof; and a basic substance is excellent in dissolution, is stable even after a long term storage, and is useful as a preventive or therapeutic agent against a tumor: wherein, R 1 is a hydrogen atom, a C 1-6 alkyl group or a C 3-8 cycloalkyl group; and R 2 is a hydrogen atom or a methoxy group.
1 . A pharmaceutical composition comprising
(1) a compound represented by the formula (I) or pharmaceutically acceptable salt thereof or solvate thereof:
wherein R 1 is a hydrogen atom, a C 1-6 alkyl group or a C 3-8 cycloalkyl group; and R 2 represents a hydrogen atom or a methoxy group; and
(2) a basic substance.
2 . The composition according to claim 1 , wherein the basic substance is a carbonate.
3 . The composition according to claim 2 , wherein the salt is an alkaline earth metal salt.
4 . The composition according to claim 3 , wherein the alkaline earth metal salt is a magnesium salt or a calcium salt.
5 . The composition according to claim 1 , further comprising a disintegrating agent.
6 . The composition according to claim 5 , wherein the disintegrating agent is carmellose sodium, carmellose calcium, carboxymethyl starch sodium, croscarmellose sodium, low-substituted hydroxypropylcellulose or crospovidone.
7 . The composition according to claim 1 , wherein R 1 is a hydrogen atom, a methyl group, an ethyl group, an n-propyl group or a cyclopropyl group.
8 . The composition according to claim 1 , wherein R 1 is a cyclopropyl group.
9 . The composition according to claim 1 , wherein R 2 is a hydrogen atom, a methoxy group or an ethoxy group.
10 . The composition according to claim 1 , wherein R 2 is a hydrogen atom.
11 . The composition according to claim 1 , wherein the pharmaceutically acceptable salt is hydrochloride, hydrobromide, p-toluenesulfonate, sulfate, methanesulfonate or ethanesulfonate.
12 . The composition according to claim 1 , wherein the compound represented by the formula (I) is 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide methanesulfonate.