Crystalline form of a drug

Abstract

Atrasentan Hydrochloride Crystalline Form 3, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.

What is claimed is: 
     
         1 . Atrasentan Hydrochloride Crystalline Form 3 characterized, when measured at about 25° C. with Cu-Kα radiation, by a powder diffraction pattern with peaks having respective 2θ values of about 6.7° and 21.95° and at least one peak having a respective 2θ value of about 8.4°, 15.6°, 18.0°, 18.5°, 19.8° or 20.6°. 
     
     
         2 . A composition made with or comprising an excipient and Atrasentan Hydrochloride Crystalline Form 3. 
     
     
         3 . A method for treating prostate cancer in a human comprising administering thereto a therapeutically effective amount of Atrasentan Hydrochloride Crystalline Form 3. 
     
     
         4 . A method for treating nociception in a human comprising administering thereto a therapeutically effective amount of Atrasentan Hydrochloride Crystalline Form 3. 
     
     
         5 . A method for treating bone pain associated with bone cancer in a human comprising administering thereto a therapeutically effective amount of Atrasentan Hydrochloride Crystalline Form 3. 
     
     
         6 . A method for inhibiting bone metastases in a human having prostate cancer that has metastasized to bone comprising administering thereto a therapeutically effective amount of Atrasentan Hydrochloride Crystalline Form 3. 
     
     
         7 . A process for making Atrasentan Hydrochloride Crystalline Form 3 having substantial crystalline purity, the process comprising the acts of:
 providing a mixture comprising the atrasentan or the solvate thereof and solvent, wherein the atrasentan is completely dissolved in the solvent; and   causing Atrasentan Hydrochloride Crystalline Form 3 to exist in the mixture or allowing Atrasentan Hydrochloride Crystalline Form 3 having substantial crystalline purity to develop in the mixture, the Atrasentan Hydrochloride Crystalline Form 3, when isolated and measured at about 25° C. with Cu-Kα radiation, characterized by a powder diffraction pattern with peaks having respective 2θ values of about 6.7° and 21.95° and at least one peak having a respective 2θ value of about 8.4°, 15.6°, 18.0°, 18.5°, 19.8° or 20.6°.   
     
     
         8 . The process of  claim 7  further comprising isolating the Atrasentan Hydrochloride Crystalline Form 3.