STABLE PHARMACEUTICAL COMPOSITION AND METHODS OF USING SAME
The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
1 - 10 . (canceled)
11 . A pharmaceutical composition comprising ethyl eicosapentaenoate (EPA-E), lecithin, and one or more surfactants, wherein the EPA-E is present in an amount of at least about 90% by weight of all omega-3 fatty acids in the composition.
12 . The pharmaceutical composition of claim 11 , wherein the EPA-E is present in an amount of at least about 96 wt. % of all omega-3 fatty acids in the composition.
13 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition comprises the composition contains not more than 0.6% of any individual fatty acid other than EPA-E.
14 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition is free of docosahexaenoic acid.
15 . The pharmaceutical composition of claim 11 , wherein the composition comprises two surfactants.
16 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition is encapsulated in a capsule shell.
17 . The pharmaceutical composition of claim 11 , wherein the EPA-E is present in the pharmaceutical composition in an amount of from about 100 mg to about 1000 mg.
18 . The pharmaceutical composition of claim 17 , wherein the EPA-E is present in the pharmaceutical composition in an amount of about 800 mg.
19 . A method of lowering triglycerides in a subject with fasting triglycerides of form about 500 mg/dl to about 2500 mg/dL, comprising orally administering to the subject daily a pharmaceutical composition comprising ethyl eicosapentaenoate (EPA-E), lecithin, and one or more surfactants, wherein the EPA-E is present in an amount of at least about 90% by weight of all omega-3 fatty acids in the composition for a period effective to reduce triglycerides in the subject without increasing LDL-C by more than 20%.
20 . The method of claim 19 , wherein the subject has fasting serum triglycerides of at least 500 mg/dL.
21 . The method of claim 19 , wherein the subject has fasting serum triglycerides of at least 700 mg/dL.
22 . The method of claim 19 , comprising administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 10% in the subject.
23 . The method of claim 19 , comprising administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 20% in the subject.
24 . The method of claim 19 , comprising administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides without increasing LDL-C by more than 10%.
25 . The method of claim 19 , comprising administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C by 5% in the subject.
26 . The method of claim 19 , comprising administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C in the subject.
27 . The method of claim 19 , wherein the EPA-E is present in an amount of at least about 96 wt. % of all omega-3 fatty acids in the composition.
28 . The method of claim 19 , wherein the pharmaceutical composition comprises the composition contains not more than 0.6% of any individual fatty acid other than EPA-E.
29 . The method of claim 19 , wherein the EPA-E is present in the pharmaceutical composition in an amount of from about 100 mg to about 1000 mg.
30 . The method of claim 19 , wherein the EPA-E is present in the pharmaceutical composition in an amount of about 800 mg.