Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

Abstract

Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed.

1 . (canceled) 
     
     
         2 . A method for preparing crystalline Form A of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione, comprising the step of dissolving 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione in a non-aqueous solvent system. 
     
     
         3 . The method of  claim 2 , wherein the solvent system comprises one or more solvent from the group consisting of 1-butanol, butyl acetate, ethanol, ethyl acetate, methanol, methyl ethyl ketone, and THF. 
     
     
         4 . The method of  claim 3 , wherein the solvent system comprises 1-butanol. 
     
     
         5 . The method of  claim 3 , wherein the solvent system comprises butyl acetate. 
     
     
         6 . The method of  claim 3 , wherein the solvent system comprises ethanol. 
     
     
         7 . The method of  claim 3 , wherein the solvent system comprises ethyl acetate. 
     
     
         8 . The method of  claim 3 , wherein the solvent system comprises methanol. 
     
     
         9 . The method of  claim 3 , wherein the solvent system comprises methyl ethyl ketone. 
     
     
         10 . The method of  claim 3 , wherein the solvent system comprises THF. 
     
     
         11 . The method of  claim 2 , wherein the 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione is dissolved in a non-aqueous solvent system at an elevated temperature. 
     
     
         12 . The method of  claim 11 , wherein the elevated temperature is from about 45° C. to about 65° C. 
     
     
         13 . The method of  claim 12 , wherein the temperature is about 60° C. 
     
     
         14 . The method of  claim 13 , wherein the 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione is further cooled. 
     
     
         15 . The method of  claim 14 , wherein the 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione is further filtered. 
     
     
         16 . The method of  claim 15 , wherein the 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione is further dried.