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Claims for Patent: 9,012,501

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Claims for Patent: 9,012,501

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 to 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:13/734,643
Patent Claims: 1. A pharmaceutical dosage form, comprising: a soft gelatin capsule comprising Porcine Type A gelatin; and a pharmaceutical formulation inside the capsule comprising at least one omega-3 polyunsaturated fatty acid in free acid form; wherein the capsule comprises sufficient Porcine Type A gelatin such that the capsule disintegrates within a time period of not more than 30 minutes 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 at least one 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 at least one 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 further comprising a coating on the outside of the capsule.

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

9. The pharmaceutical dosage form of claim 7, wherein the coating is a time-dependent but not pH-dependent release coating.

10. The pharmaceutical dosage form of claim 7, wherein the coating is resistant to dissolution in a pH-dependent manner.

11. The pharmaceutical dosage form of claim 7, wherein the coating delays release of the formulation from the capsule until after passage of the capsule through the stomach.

12. The pharmaceutical dosage form of claim 7, wherein the coating is a neutral polyacrylate coating.

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

14. The pharmaceutical dosage form of claim 1 or 7, wherein the gelatin of the capsule consists essentially of Porcine Type A gelatin.

15. The pharmaceutical dosage form of claim 1 or 7, wherein about 100 mg to about 2000 mg of the pharmaceutical formulation is inside the capsule.

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

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

18. A method of treating hypertriglyceridemia comprising administering to a patient in need thereof an effective amount of the pharmaceutical dosage form of claim 1 or 7.

19. The method of claim 18, wherein the effective amount of the pharmaceutical dosage form comprises about 1 g to about 8 g per day of the pharmaceutical formulation.

20. The method of claim 19, wherein the effective amount of the pharmaceutical dosage form comprises about 4 g per day of the pharmaceutical formulation.
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