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Claims for Patent: 8,383,678

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Claims for Patent: 8,383,678

Title:Type a gelatin capsule containing PUFA in free acid form
Abstract: A pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form or a pharmacologically acceptable derivative thereof is contained in a soft gelatin capsule characterized in that the capsule comprises gelatin extracted by an extraction process comprising acid pre-treatment of a collagen source. One advantage of the present invention over a soft gelatin capsule containing the same formulation but comprising gelatin extracted by an extraction process comprising alkali pre-treatment of the collagen source is that the present invention does not harden significantly over time and thus has a longer shelf life.
Inventor(s): Sachetto; Jean-Pierre (Arlesheim, CH), Bufton; Roly (Bubendorf, CH), Buser; Thomas (Nuglar, CH)
Assignee: Chrysalis Pharma AG (Sachseln, CH)
Application Number:12/984,994
Patent Claims: 1. A soft gelatin capsule, comprising: inside said capsule, a pharmaceutical composition comprising at least about 50 wt % of 5,8,11,14,17-eicosapentaenoic acid in free acid form, and wherein said capsule comprises sufficient porcine Type A gelatin such that the capsule disintegrates within a time period of not more than 30 min in purified water at 37.degree. C. after storage for at least 3 months at 40.degree. C.

2. The soft gelatin capsule of claim 1, wherein said capsule comprises sufficient porcine Type A gelatin such that the capsule disintegrates within a time period of not more than 30 min in purified water at 37.degree. C. after storage for 6 months at 40.degree. C.

3. The soft gelatin capsule of claim 1, wherein said capsule comprises sufficient porcine Type A gelatin such that the capsule disintegrates within a time period of not more than 30 min in purified water at 37.degree. C. after storage for 12 months at 40.degree. C.

4. A soft gelatin capsule, comprising: inside said capsule, a pharmaceutical composition comprising at least about 50 wt % 5,8,11,14,17-eicosapentaenoic acid in free acid form, and wherein the gelatin of said capsule consists essentially of porcine Type A gelatin.

5. The soft gelatin capsule of claim 1, wherein said pharmaceutical composition comprises from about 50 wt % to about 60 wt % of 5,8,11,14,17-eicosapentaenoic acid in free acid form.

6. The soft gelatin capsule of claim 1, wherein said pharmaceutical composition further comprises about 20 wt % to about 30 wt % of 4,7,10,13,16,19-docosahexaenoic acid in free acid form.

7. The soft gelatin capsule of claim 5, wherein said pharmaceutical composition further comprises about 20 wt % to about 30 wt % of 4,7,10,13,16,19-docosahexaenoic acid in free acid form.

8. The soft gelatin capsule of claim 1, which comprises, inside said capsule, from about 100 mg to about 2000 mg of said pharmaceutical composition.

9. The soft gelatin capsule of claim 8, which comprises, inside said capsule, about 500 mg of the pharmaceutical composition.

10. The soft gelatin capsule of claim 8, which comprises, inside said capsule, about 1000 mg of the pharmaceutical composition.

11. The soft gelatin capsule of claim 8, further comprising a neutral polyacrylate coating.

12. The soft gelatin capsule of claim 11, wherein the coating is poly(ethylacrylate-methylmethacrylate).

13. A method of treating hypertriglyceridemia, comprising: administering to a patient with hypertriglyceridemia an effective number of soft gelatin capsules, wherein each capsule comprises, inside said capsule, a pharmaceutical composition comprising at least about 50 wt % of 5,8,11,14,17-eicosapentaenoic acid in free acid form, and wherein each capsule comprises sufficient porcine Type A gelatin such that the capsule disintegrates within a time period of not more than 30 min in purified water at 37.degree. C. after storage for at least 3 months at 40.degree. C.

14. The method of claim 13, wherein said pharmaceutical composition comprises from about 50 wt % to about 60 wt % of 5,8,11,14,17-eicosapentaenoic acid in free acid form.

15. The method of claim 13, wherein said pharmaceutical composition further comprises about 20 wt % to about 30 wt % of 4,7,10,13,16,19-docosahexaenoic acid in free acid form.

16. The method of claim 14, wherein said pharmaceutical composition further comprises about 20 wt % to about 30 wt % of 4,7,10,13,16,19-docosahexaenoic acid in free acid form.

17. The method of claim 13, wherein the soft gelatin capsule further comprises a neutral polyacrylate coating.

18. The method of claim 17, wherein the coating is poly(ethylacrylate-methylmethacrylate).

19. The method of claim 13, wherein a plurality of soft gelatin capsules is administered daily.

20. The method of claim 19, wherein each soft gelatin capsule comprises from about 100 mg to about 2000 mg of the pharmaceutical composition.
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