Amorphous form of tetracyclic compound

Abstract

An amorphous form of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile and a solid dispersion containing the amorphous form can be used extremely advantageously as drugs for oral administration.

1 . A method of producing an amorphous form of a compound represented by formula (I):
                       a salt thereof, or a solvate of the compound or a salt thereof, the method comprising the steps of:
 (i) dissolving the compound represented by the formula (I), the salt thereof, or the solvate of the compound or the salt thereof into a solvent to prepare a feed solution; 
 (ii) spraying the feed solution obtained in the step (i); and 
 (iii) drying the sprayed feed solution to provide the amorphous form of the compound represented by the formula (I), the salt thereof, or the solvate of the compound or the salt thereof. 
   
     
     
         2 . The method according to  claim 1 , wherein the solvent is tetrahydrofuran. 
     
     
         3 . The method according to  claim 2 , wherein a concentration of the tetrahydrofuran is between 65% and 85%. 
     
     
         4 . A method of producing a solid dispersion comprising an amorphous form of a compound represented by the formula (I), a salt thereof, or a solvate of the compound or a salt thereof; and an inert carrier, the method comprising a spray drying step.