DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
AssigneesOmthera Pharmaceuticals, Inc., Chrysalis Pharma AG
InventorsTimothy J. Maines, Bernardus N. Machielse, Bharat M. Mehta, Gerald L. Wisler, Michael H. Davidson, Peter Ralph Wood
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Abstract
DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented.
Claims43
A method of treating hypertriglyceridemia, comprising orally administering to a patient having pre-treatment serum or plasma triglyceride levels of about 200 mg/dL to about 500 mg/dL a therapeutically effective amount of a pharmaceutical composition comprising:
- eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight;
- docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight;
- and
- docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight;
- wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form;
- and
- wherein the composition is not administered at the same time as a statin.
A method of treating hypertriglyceridemia, comprising orally administering to a patient having pre-treatment serum or plasma triglyceride levels of about 200 mg/dL to about 500 mg/dL a therapeutically effective amount of a pharmaceutical composition and a therapeutically effective amount of a statin;
- wherein
- the pharmaceutical composition comprises:
- eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight;
- docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight;
- and
- docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight;
- wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form;
- the statin is administered on a dosage schedule different from the pharmaceutical composition;
- and
- the method comprises administering a single statin.
A method of treating hypertriglyceridemia, comprising orally administering to a patient having pre-treatment serum or plasma triglyceride levels of about 200 mg/dL to about 500 mg/dL a therapeutically effective amount of a pharmaceutical composition comprising polyunsaturated fatty acids as the sole active pharmaceutical ingredient;
- wherein
- at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form;
- and
- the polyunsaturated fatty acids comprise:
- eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight of the composition;
- docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight of the composition;
- and
- docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight of the composition.
Dependencies are inferred from the claim text.