Crystalline forms of sodium 4--2-methoxybenzoate

Abstract

The present invention is directed to a compound of formula (I): or a crystalline form thereof, or a solvate thereof; to a solid pharmaceutical composition comprising a pharmaceutically effective amount of the compound of formula (I), or a crystalline form thereof, or a solvate thereof, and at least one pharmaceutically acceptable carrier or diluent, and to the use of a compound of formula (I), or a crystalline form thereof, or a solvate thereof, for treating a patient suffering from, or subject to, a disease, disorder, or condition mediated by Aurora kinase, and methods related thereto.

1 - 22 . (canceled) 
     
     
         23 . A crystalline form of the compound of formula (I): 
       
         
           
           
               
               
           
         
         wherein the crystalline form is Form 2. 
       
     
     
         24 . The crystalline form of  claim 23 , characterized by at least one of the following features:
 an X-ray powder diffraction pattern having peaks at 2θ angles of 3.44°, 13.11°, 13.73° and 22.84°;   a differential scanning calorimetry (DSC) profile substantially similar to  FIG. 5 ; and   a thermal gravimetric analysis (TGA) profile substantially similar to  FIG. 6 .   
     
     
         25 . The crystalline form of  claim 24 , characterized by an X-ray powder diffraction pattern having peaks at 2θ angles of 3.44°, 13.11°, 13.73°, 14.36°, 17.31° and 22.84°. 
     
     
         26 . The crystalline form of  claim 24 , characterized by an X-ray powder diffraction pattern substantially similar to  FIG. 4 . 
     
     
         27 . The crystalline form of  claim 24 , characterized by at least two of the following features:
 an X-ray powder diffraction pattern having peaks at 2θ angles of 3.44°, 13.11°, 13.73° and 22.84°;   a differential scanning calorimetry (DSC) profile substantially similar to  FIG. 5 ; and   a thermal gravimetric analysis (TGA) profile substantially similar to  FIG. 6 .   
     
     
         28 . The crystalline form of  claim 24 , characterized by each of the following features:
 an X-ray powder diffraction pattern having peaks at 2θ angles of 3.44°, 13.11°, 13.73° and 22.84°;   a differential scanning calorimetry (DSC) profile substantially similar to  FIG. 5 ; and   a thermal gravimetric analysis (TGA) profile substantially similar to  FIG. 6 .   
     
     
         29 . A solid pharmaceutical composition comprising the crystalline form according to  claim 23 , and at least one pharmaceutically acceptable carrier or diluent. 
     
     
         30 . A method for treating cancer comprising administering a therapeutically effective amount of the crystalline form according to  claim 23  to a patient in need thereof. 
     
     
         31 . The method of  claim 30 , wherein the cancer is pancreatic cancer, bladder cancer, colorectal cancer, breast cancer, prostate cancer, renal cancer, hepatocellular cancer, lung cancer, ovarian cancer, cervical cancer, gastric cancer, esophageal cancer, head and neck cancer, melanoma, neuroendocrine cancer, brain tumors, bone cancer or soft tissue sarcoma. 
     
     
         32 . The method of  claim 30 , wherein the cancer is acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, B-cell lymphoma, T-cell lymphoma, multiple myeloma, Waldenstrom's macroglobulinemia, myelodysplastic syndromes or myeloproliferative syndromes. 
     
     
         33 . The method of  claim 30 , wherein the cancer is NHL, AML, MDS, colorectal cancer, ovarian cancer, breast cancer, gastric cancer, prostate cancer or pancreatic cancer.