Pharmaceutical composition comprising eicosapentaenoic acid and derivatives thereof and a statin

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and a statin and to methods of using the same to treat or prevent cardiovascular-related diseases.

1 . A dosage unit comprising:
 a capsule shell having a surface layer comprising a statin selected from the group consisting of atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin; and   a fill comprising about 1 g eicosapentaenoate,
 wherein: 
 the fill comprises at least about 80% by weight, of all the fatty acids present in the fill, ethyl eicosapentaenoate and substantially no docosahexaenoic acid (DHA) or a derivative thereof. 
   
     
     
         2 . The dosage unit of  claim 1 , wherein the statin is present in a coating on an exterior surface of the capsule shell. 
     
     
         3 . The dosage unit of  claim 1 , wherein the capsule shell comprises gelatin. 
     
     
         4 . (canceled) 
     
     
         5 . The dosage unit of  claim 1 , wherein the statin is present in an amount of about 1 mg to about 160 mg. 
     
     
         6 . (canceled) 
     
     
         7 . The dosage unit of  claim 1 , wherein the statin is rosuvastatin. 
     
     
         8 . A dosage unit comprising:
 a capsule shell; and   a fill comprising a statin and about 1 g ethyl eicosapentaenoate,   wherein:   the statin is selected from the group consisting of atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin; and   the fill comprises at least about 80% by weight, of all the fatty acids present in the fill, ethyl eicosapentaenoate and substantially no docosahexaenoic acid (DHA) or a derivative thereof.   
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . The dosage unit of  claim 8 , wherein the statin is suspended in the ethyl eicosapentaenoate. 
     
     
         12 . The dosage unit of  claim 8 , wherein the capsule shell comprises gelatin. 
     
     
         13 . (canceled) 
     
     
         14 . The dosage unit of  claim 8 , wherein the statin is present in an amount of about 1 mg to about 160 mg. 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . A method of treating or preventing a cardiovascular-related disease or disorder in a subject, the method comprising administering to the subject a dosage unit comprising a capsule shell having a surface layer comprising a statin and a fill comprising eicosapentaenoate or a derivative thereof or a dosage unit comprising a capsule shell comprising a statin selected from the group consisting of atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin and a fill comprising about 1 g ethyl eicosapentaenoate,
 wherein:   the fill comprises at least about 80% by weight, of all the fatty acids present in the fill, ethyl eicosapentaenoate and substantially no docosahexaenoic acid (DHA) or a derivative thereof.   
     
     
         18 . (canceled) 
     
     
         19 . The dosage unit of  claim 1 , wherein the statin is atorvastatin. 
     
     
         20 . The dosage unit of  claim 1 , wherein the statin is fluvastatin. 
     
     
         21 . The dosage unit of  claim 1 , wherein the statin is lovastatin. 
     
     
         22 . The dosage unit of  claim 1 , wherein the statin is pravastatin. 
     
     
         23 . The unit dosage of  claim 1 , wherein the statin is simvastatin. 
     
     
         24 . The method of  claim 17 , wherein the statin is present in an amount of about 1 mg to 160 mg.