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Claims for Patent: 9,132,112

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Claims for Patent: 9,132,112

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: CHYSALIS PHARMA AG (Sachesln, CH)
Application Number:14/258,523
Patent Claims: 1. A pharmaceutical dosage form, comprising: a) a pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form; b) a soft gelatin capsule containing the formulation inside the capsule; and c) a coating on the outside of the capsule; wherein the capsule comprises sufficient porcine Type A gelatin such that, when containing the formulation, the uncoated capsule disintegrates within a time period of no longer than 30 min in purified water at 37.degree. C. after storage for 3 months at 40.degree. C.

2. The pharmaceutical dosage form of claim 1, wherein the formulation comprises at least about 50 wt % of the omega-3 polyunsaturated fatty acid in free acid form.

3. The pharmaceutical dosage form of claim 1, wherein the formulation comprises at least about 90 wt % of the omega-3 polyunsaturated fatty acid in free acid form.

4. The pharmaceutical dosage form of claim 1, wherein the at least one omega-3 polyunsaturated fatty acid in free acid form comprises 5,8,11,14,17-eicosapentaenoic acid (EPA) in free acid form.

5. The pharmaceutical dosage form of claim 4, wherein the at least one omega-3 polyunsaturated fatty acid in free acid form further comprises 4,7,10,13,16,19-docosahexaenoic acid (DHA) in free acid form.

6. The pharmaceutical dosage form of claim 1, wherein the at least one omega-3 polyunsaturated fatty acid in free acid form comprises 4,7,10,13,16,19-docosahexaenoic acid (DHA) in free acid form.

7. The pharmaceutical dosage form of claim 1, wherein the coating delays release of the formulation from the capsule after oral administration of the capsule.

8. The pharmaceutical dosage form of claim 1, wherein release of the formulation from the capsule is delayed until after passage of the capsule through the stomach.

9. The pharmaceutical dosage form of claim 1, wherein the coating is a time-dependent but not pH-dependent release coating.

10. The pharmaceutical dosage form of claim 1, wherein the coating is resistant to dissolution in a pH-dependent manner.

11. The pharmaceutical dosage form of claim 1, wherein the coating is a neutral polyacrylate coating.

12. The pharmaceutical dosage form of claim 11, wherein the coating is a poly(ethylacrylate-methylmethacrylate) coating.

13. The pharmaceutical dosage form of claim 1, wherein the gelatin of the capsule consists essentially of porcine Type A gelatin.

14. The pharmaceutical dosage form of claim 1, wherein about 100 mg to about 15 mg of the pharmaceutical formulation is inside the capsule.

15. The pharmaceutical dosage form of claim 1, wherein about 500 mg of the pharmaceutical formulation is inside the capsule.

16. The pharmaceutical dosage form of claim 1, wherein about 1000 mg of the pharmaceutical formulation is inside the capsule.

17. A method of treating hypertriglyceridemia comprising administering to a patient in need thereof an effective amount of the pharmaceutical dosage form of claim 1.

18. The method of claim 17, wherein the effective amount is about 1 g to about 8 g per day of the pharmaceutical formulation.

19. The method of claim 17, wherein the effective amount is about 4 g per day of the pharmaceutical formulation.

20. A pharmaceutical dosage form comprising: a) a soft gelatin capsule consisting essentially of porcine Type A gelatin; b) a pharmaceutical formulation contained inside the capsule and comprising at least one omega-3 polyunsaturated fatty acid in free acid form; and c) a coating on the outside of the capsule.

21. The pharmaceutical dosage form of claim 20, wherein the formulation comprises at least about 50 wt % of the omega-3 polyunsaturated fatty acid in free acid form.

22. The pharmaceutical dosage form of claim 20, wherein the formulation comprises at least about 90 wt % of the omega-3 polyunsaturated fatty acid in free acid form.

23. The pharmaceutical dosage form of claim 21, wherein the at least one omega-3 polyunsaturated fatty acid in free acid form comprises 5,8,11,14,17-eicosapentaenoic acid (EPA) in free acid form.

24. The pharmaceutical dosage form of claim 23, wherein the at least one omega-3 polyunsaturated fatty acid in free acid form further comprises 4,7,10,13,16,19-docosahexaenoic acid (DHA) in free acid form.

25. The pharmaceutical dosage form of claim 20, wherein the at least one omega-3 polyunsaturated fatty acid in free acid form comprises 4,7,10,13,16,19-docosahexaenoic acid (DHA) in free acid form.

26. The pharmaceutical dosage form of claim 20, wherein the coating delays release of the formulation from the capsule after oral administration of the capsule.

27. The pharmaceutical dosage form of claim 20, wherein release of the formulation from the capsule is delayed until after passage of the capsule through the stomach.

28. The pharmaceutical dosage form of claim 20, wherein the coating is a time-dependent but not pH-dependent release coating.

29. The pharmaceutical dosage form of claim 20, wherein the coating is resistant to dissolution in a pH-dependent manner.

30. The pharmaceutical dosage form of claim 20, wherein the coating is a neutral polyacrylate coating.

31. The pharmaceutical dosage form of claim 30, wherein the coating is a poly(ethylacrylate-methylmethacrylate) coating.

32. The pharmaceutical dosage form of claim 20, wherein about 100 mg to about 2000 mg of the pharmaceutical formulation is inside the capsule.

33. The pharmaceutical dosage form of claim 20, wherein about 500 mg of the pharmaceutical formulation is inside the capsule.

34. The pharmaceutical dosage form of claim 20, wherein about 1000 mg of the pharmaceutical formulation is inside the capsule.

35. A method of treating hypertriglyceridemia comprising administering to a patient in need thereof an effective amount of the pharmaceutical dosage form of claim 20.

36. The method of claim 35, wherein the effective amount of is about 1 g to about 8 g per day of the pharmaceutical formulation.

37. The method of claim 35, wherein the effective amount is about 4 g per day of the pharmaceutical formulation.
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