Pharmaceutical compositions comprising fluvastatin

Abstract

Pharmaceutical compositions comprising fluvastatin, HPMC and optionally other pharmaceutical excipients which are colour-stable upon prolonged periods of storage.

1 . A pharmaceutical composition comprising fluvastatin and HPMC which is colour-stable upon prolonged periods of storage.  
     
     
         2 . A pharmaceutical composition according to  claim 1  in the form of an oral dosage form.  
     
     
         3 . A pharmaceutical composition according to  claim 1  in the form of granules.  
     
     
         4 . A pharmaceutical composition comprising compressed granules comprising fluvastatin and HPMC, wherein said granules have a mean particle size of less than 200 microns.  
     
     
         5 . Granules comprising fluvastatin and HPMC wherein the granules have a mean particle size of less than 200 microns.  
     
     
         6 . A pharmaceutical composition or granules according to any preceding claim additionally comprising a coating wherein said coating comprises up to 73% by weight of a colouring agent based on the total weight of the coating, more particularly 17 to 30%.  
     
     
         7 . A pharmaceutical composition or granules according to any of the preceding claims wherein the HPMC comprises up to 12 percent hydroxypropyl functionality and has a number average molecular weight of about 20,000 to 170,000.  
     
     
         8 . A pharmaceutical composition or granules according to any of the preceding claims wherein the HPMC is present in amounts of from 15 to 50% by weight based on the total weight of the composition.  
     
     
         9 . A pharmaceutical composition or granules according to any of the preceding claims additionally comprising a non-ionic hydrophilic polymer selected from hydroxyethyl cellulose or hydroxypropyl cellulose.  
     
     
         10 . A pharmaceutical composition or granules according to any of the preceding claims wherein the ratio of HPMC to non-hydrophilic polymer is about 10:1 to 3:11.  
     
     
         11 . A pharmaceutical composition or granules wherein the fluvastatin is fluvastatin sodium.  
     
     
         12 . A method of preventing or substantially reducing the formation of gels of hydrated HPMC in a pharmaceutical composition or in granules comprising a fluvastatin and HPMC comprising the step of storing the pharmaceutical composition or granules at a relative humidity not exceeding 75% and at a temperature of between 25° C. and 40° C.  
     
     
         13 . A method of preventing or substantially reducing the formation of gels of hydrated HPMC in a pharmaceutical composition comprising fluvastatin and HPMC comprising the step of compressing granules comprising fluvastatin and HPMC, wherein said granules have a mean granule particle size of less than 200 microns.  
     
     
         14 . The method according to  claim 12  wherein the pharmaceutical composition is formed of compressed granules.  
     
     
         15 . The method according to  claim 12  to  14  wherein the fluvastatin is fluvastatin sodium.