Pharmaceutical composition comprising eicosapentaenoic acid and nicotinic acid and methods of using same

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising eicosapentaenoic acid and/or derivatives thereof and nicotinic acid, to methods of manufacturing such compositions, and to therapeutic methods for treating carious diseases and disorders.

1 - 15 . (canceled) 
     
     
         16 . A composition comprising eicosapentaenoic acid (EPA) co-formulated with a statin, wherein:
 i) the EPA comprises at least 90% by weight of all fatty acids in the composition; or   ii) the composition contains less than 10% by weight of the total composition, or by weight of the total fatty acid content, of any fatty acid other than EPA; or   iii) the composition comprises not more than 10% docosahexaenoic acid (DHA) or a derivative thereof.   
     
     
         17 . The composition of  claim 16 , wherein the solid dosage forms comprise one or more of a tablet, a caplet, a capsule, a powder, a lozenge, a sachet, a cachet, a troche, a pellet, a granule, a microgranule, an encapsulated microgranule, or a powder aerosol formulation. 
     
     
         18 . The composition of  claim 17 , wherein the EPA and the statin are co-formulated in the same dosage unit. 
     
     
         19 . The composition of  claim 17 , wherein the statin is dispersed or suspended in the EPA, and wherein the dispersion or suspension is present in a capsule. 
     
     
         20 . The composition of  claim 19 , wherein the statin is selected from the group consisting of pravastatin, lovastatin, simvastatin, atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and a salt thereof. 
     
     
         21 . The composition of  claim 20 , wherein the statin is rosuvastatin. 
     
     
         22 . The composition of  claim 21 , wherein the dosage of rosuvastatin is from about 1 to about 80 mg. 
     
     
         23 . The composition of  claim 16 , wherein the EPA is a C 1 -C 5  alkyl ester of EPA. 
     
     
         24 . The composition of  claim 16 , wherein the EPA is ethyl-EPA. 
     
     
         25 . A method of treating a cardiovascular disease or disorder, comprising administering to a subject in need thereof, a composition comprising EPA co-formulated with a statin, wherein:
 i) the EPA comprises at least 90% by weight of all fatty acids in the composition; or   ii) the composition contains less than 10% by weight of the total composition, or by weight of the total fatty acid content, of any fatty acid other than EPA; or   iii) the composition comprises not more than 10% DHA or a derivative thereof.   
     
     
         26 . The method of  claim 25 , wherein the solid dosage forms of the composition comprise one or more of a tablet, a caplet, a capsule, a powder, a lozenge, a sachet, a cachet, a troche, a pellet, a granule, a microgranule, an encapsulated microgranule, or a powder aerosol formulation. 
     
     
         27 . The method of  claim 26 , wherein the EPA and the statin are co-formulated in the same dosage unit. 
     
     
         28 . The method of  claim 26 , wherein the statin is dispersed or suspended in the EPA, and wherein the dispersion or suspension is present in a capsule. 
     
     
         29 . The method of  claim 28 , wherein the statin is selected from the group consisting of pravastatin, lovastatin, simvastatin, atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and a salt thereof. 
     
     
         30 . The method of  claim 29 , wherein the statin is rosuvastatin. 
     
     
         31 . The method of  claim 30 , wherein the dosage of rosuvastatin is from about 1 to about 80 mg. 
     
     
         32 . The method of  claim 25 , wherein the EPA is a C 1 -C 5  alkyl ester of EPA. 
     
     
         33 . The method of  claim 25 , wherein the EPA is ethyl-EPA.