Crystalline Form of Pemirolast

Abstract

There is provided a hemihydrate form of the sodium salt of pemirolast.

1 - 19 . (canceled) 
     
     
         20 . A compound prepared by a process according to  claim 42 . 
     
     
         21 . (canceled) 
     
     
         22 . A pharmaceutical formulation comprising a compound as claimed in  claim 42  in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier. 
     
     
         23 - 24 . (canceled) 
     
     
         25 . A method of treatment of an inflammatory disorder, which method comprises the administration of a compound as defined in  claim 42  to a patient in need of such treatment. 
     
     
         26 . A method as claimed in  claim 25 , wherein the disorder is atherosclerosis or an associated cardiovascular disorder. 
     
     
         27 . A method as claimed in  claim 26 , wherein the disorder is atherosclerosis. 
     
     
         28 . A method as claimed in  claim 26 , wherein the cardiovascular disorder associated with atherosclerosis is selected from an aortic aneurysm, arteriosclerosis, peripheral arterial occlusive disease, a coronary artery disease, a coronary disease, plaque rupture and/or instability, atheroma rupture and/or instability, a vascular disease, an arterial disease, an ischaemic disease, ischaemia and stroke. 
     
     
         29 - 30 . (canceled) 
     
     
         31 . A method as claimed in  claim 26 , wherein the patient has an acute coronary syndrome. 
     
     
         32 . A method as claimed in  claim 25 , wherein the disorder is systemic low grade inflammation. 
     
     
         33 . A method as claimed in  claim 25 , wherein the disorder is selected from metabolic syndrome, obesity, diabetes mellitus and/or a diabetic vascular complication. 
     
     
         34 . A combination product comprising:
 (a) a compound as defined in  claim 42 ; and   (b) one or more active ingredient that is useful in the treatment of an inflammatory disorder, or a pharmaceutically-acceptable salt or solvate thereof.   
     
     
         35 - 40 . (canceled) 
     
     
         41 . A compound according to  claim 42  which is substantially crystallographically pure. 
     
     
         42 . A solid form of the sodium salt of pemirolast having an X-ray powder diffraction pattern as shown in  FIG. 7 . 
     
     
         43 . A solid form of the sodium salt of pemirolast having an X-ray powder diffraction pattern with degrees 2-Theta values of about 24.9, 26.3, 26.5, 27.9, 28.2, and 28.8. 
     
     
         44 . A compound according to  claim 43  which is substantially crystallographically pure. 
     
     
         45 . A process for the preparation of the form of the sodium salt of pemirolast of  claim 42 , wherein the process comprises subjecting a hemihydrate form of the sodium salt of pemirolast to at least about 75% relative humidity. 
     
     
         46 . A process for the preparation of the form of the sodium salt of pemirolast of  claim 42 , wherein the process comprises subjecting a heptahydrate form of the sodium salt of pemirolast to at least about 75% relative humidity. 
     
     
         47 . A process for the preparation of the form of the sodium salt of pemirolast of  claim 42 , wherein the process comprises subjecting an amorphous form of the sodium salt of pemirolast to at least about 60% relative humidity. 
     
     
         48 . A compound prepared by a process according to  claim 45 . 
     
     
         49 . A compound prepared by a process according to  claim 46 . 
     
     
         50 . A compound prepared by a process according to  claim 47 .