PHARMACEUTICAL COMPOSITION COMPRISING EICOSAPENTAENOIC ACID AND NICOTINIC ACID AND METHODS OF USING SAME
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.