Fluvastatin sodium crystal forms, processes for preparing them, compositions containing them and methods of using them

Abstract

Provided are crystalline forms of fluvastatin sodium and processes for their preparation.

1 - 4 . (canceled) 
     
     
         5 . A crystalline form of fluvastatin sodium characterized by a PXRD pattern having peaks at 3.64, 4.66, 7.30, 8.84, 11.61±0.2 degrees two-theta. 
     
     
         6 . The crystalline form of fluvastatin sodium of  claim 5  further characterized by peaks at 19.08, 19.65, 21.15, 22.59, 24.20±0.2 degrees two-theta. 
     
     
         7 . The crystalline form of fluvastatin sodium of  claim 6  further characterized by a PXRD pattern substantially as depicted in  FIG. 59 . 
     
     
         8 . The crystalline form of fluvastatin sodium of  claim 7  wherein the crystalline form is fluvastatin sodium Form XXXVIII. 
     
     
         9 . A process for preparing crystalline fluvastatin sodium Form XXXVIII comprising:
 a) forming a heterogeneous mixture of fluvastatin sodium Form XI and absolute ethanol,   b) maintaining the mixture to convert Form XI to Form XXXVIII, and   c) recovering Form XXXVIII from the mixture.   
     
     
         10 . A process for preparing crystalline fluvastatin sodium Form XXXVIII comprising:
 a) dissolving a lower alkyl ester of fluvastatin in a solution of about one molar equivalent of sodium hydroxide in ethanol,   b) inducing precipitation of Form XXXVIII by addition of ethyl acetate, and   c) separating Form XXXVIII from the ethanol and ethyl acetate.   
     
     
         11 . A pharmaceutical composition comprising an effective amount of the crystal form of fluvastatin sodium of  claim 5  and a pharmaceutically acceptable excipient. 
     
     
         12 . A method of treating a patient suffering from hypercholesterolemia or hyperlipidemia comprising the step of administering to the patient an effective amount of the pharmaceutical composition of  claim 11 .