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Details for Patent: 9,056,088

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Details for Patent: 9,056,088

Title:Pharmaceutical compositions comprising fatty acids
Abstract: The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.
Inventor(s): Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT), Manku; Mehar (Birmingham, GB)
Assignee: Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Filing Date:Feb 07, 2014
Application Number:14/175,602
Claims:1. A pharmaceutical composition comprising eicosapentaenoic acid (EPA) or a derivative of EPA, docosahexaenoic acid (DHA) or a derivative of DHA, and at least one surfactant, wherein the at least one surfactant comprises Polysorbate 80 and a poloxamer.

2. The pharmaceutical composition of claim 1 further comprising at least one additional fatty acid selected from the group consisting of linolenic acid (LA), derivative of LA, arachidonic acid (AA), derivative of AA, alpha-linolenic acid (ALA), derivative of ALA, stearadonic acid (STA), derivative of STA, eicosatrienoic acid (ETA), derivative of ETA, docosapentaenoic acid (DPA), derivative of DPA, or combinations thereof.

3. The pharmaceutical composition of claim 1 wherein the derivative of EPA is ethyl-EPA.

4. The pharmaceutical composition of claim 1 wherein the derivative of DHA is ethyl-DHA.

5. The pharmaceutical composition of claim 1 comprising a mixture of EPA or a derivative of EPA and DHA or a derivative of DHA, in a ratio of EPA or a derivative of EPA to DHA or a derivative of DHA from greater than about 2:1 to about 19:1, wherein the EPA or a derivative of EPA and DHA or a derivative of DHA in combination comprise more than about 50% by weight of total fatty acids present in the pharmaceutical composition.

6. The pharmaceutical composition of claim 1 comprising a mixture of EPA or a derivative of EPA and DHA or a derivative of DHA, wherein the EPA or a derivative of EPA comprises about 50% by weight of total fatty acids present in the pharmaceutical composition and the DHA or a derivative of DHA comprises about 20% by weight of total fatty acids present in the pharmaceutical composition.

7. The pharmaceutical composition of claim 1 wherein the at least one surfactant is selected from the group consisting a polysorbate, a poloxamer, or combinations thereof.

8. The pharmaceutical composition of claim 7 wherein the at least one polysorbate is present in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition.

9. The pharmaceutical composition of claim 1 further comprising at least one antioxidant.

10. The pharmaceutical composition of claim 9 wherein the at least one antioxidant is a tocopherol.

11. The pharmaceutical composition of claim 10 wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the pharmaceutical composition.

12. A pharmaceutical composition comprising a mixture of ethyl-EPA and ethyl-DHA in a ratio of about 2:1 to about 3.5:1, Polysorbate 80 in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition and polyoxypropylene block copolymer in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition.

13. The pharmaceutical composition of claim 12 further comprising from at least one antioxidant.

14. The pharmaceutical composition of claim 13 wherein the at least one antioxidant is a tocopherol.

15. The pharmaceutical composition of claim 14 wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the pharmaceutical composition.

16. The pharmaceutical composition of claim 1 wherein the composition is present in a capsule.
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