Quinoline derivative-containing pharmaceutical composition

Abstract

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.