Carvedilol

Abstract

This invention relates to an improved process of preparing carvedilol, as well as a new crystalline hydrate and solvate and forms of carvedilol, processes for the manufacture thereof, and pharmaceutical compositions thereof.

1 . Crystalline carvedilol hemihydrate Form III. 
   
   
       2 . The crystalline carvedilol hemihydrate of  claim 1 , characterized by an X-ray powder diffraction pattern having peaks at about 8.4±0.2, 17.4±0.2, and 22.0±0.2 degrees two-theta. 
   
   
       3 . The carvedilol hemihydrate of  claim 2 , further characterized by an X-ray powder diffraction pattern having peaks at about 9.3±0.2, 11.6±0.2, 13.2±0.2, 13.5±0.2, 14.2±0.2, 15.3±0.2, 15.8±0.2, 18.4±0.2, 19.4±0.2, 20.6±0.2, 21.4±0.2, 26.5±0.2 and 27.6±0.2 degrees two-theta. 
   
   
       4 . A method for treating a patient suffering from congestive heart failure by administering a therapeutically effective amount of crystalline carvedilol hemihydrate Form III. 
   
   
       5 . A method for treating a patient suffering from hypertension by administering a therapeutically effective amount of crystalline carvedilol hemihydrate Form III.