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Claims for Patent: 8,445,003

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Claims for Patent: 8,445,003

Title:Stable pharmaceutical composition and methods of using same
Abstract: 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.
Inventor(s): Manku; Mehar (England, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT)
Assignee: Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:13/458,496
Patent Claims: 1. A method of lowering triglycerides without increasing LDL-C in a subject having fasting baseline triglycerides of 500 mg/dl to about 1500 mg/dl comprising, administering to the subject a pharmaceutical composition comprising at least about 95%, by weight of all fatty acids present, ethyl eicosapentaenoate in one or more capsules comprising a capsule wall composed of a film-forming material that is free of succinated gelatin, wherein the composition is administered in an amount and for a period effective to reduce triglycerides by at least 25% without increasing LDL-C in the subject compared to a second subject having fasting baseline triglycerides of 500 mg/dl to about 1500 mg/dl who has not received the pharmaceutical composition.

2. The method of claim 1 wherein the film-forming material comprises gelatin, carrageenan, alkylated or hydroxyalkylated cellulose ethers, starch, alpha-starch, hydroxyalkyl starch, sodium alginate, sodium salt of a gelatin copolymer and acrylic acid, hydroxypropyl methyl cellulose, hydroxyethyl cellulose or polyvinyl alcohol.

3. The method of claim 1 wherein the film-forming material comprises at least one plasticizer.

4. The method of claim 1 wherein the at least one plasticizer comprises a hygroscopic plasticizer.

5. The method of claim 4 wherein the hygroscopic plasticizer comprises glycerol.

6. The method of claim 1 wherein the film-foaming material comprises gelatin.

7. The method of claim 1 comprising administering the composition to the subject for a period effective to reduce triglycerides by at least 30% without increasing LDL-C compared to the second subject.

8. The method of claim 7 comprising administering the composition to the subject for a period effective to reduce triglycerides by at least about 35% without increasing LDL-C compared to the second subject.

9. The method of claim 1 wherein said period is at least about 12 weeks.

10. The method of claim 1 comprising administering the composition to the subject to effect a reduction in apolipoprotein B compared to the second subject.

11. The method of claim 1 comprising administering the composition to the subject to effect at least a 5% reduction in apolipoprotein B compared to the second subject.
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