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Claims for Patent: 7,960,370

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Claims for Patent: 7,960,370

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:
Application Number:10/587,201
Patent Claims: 1. A soft gelatin capsule comprising Porcine Type A gelatin, said capsule containing a pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form, wherein the soft gelatin capsule comprising Porcine Type A gelatin exhibits a longer shelf life as compared to soft gelatin capsules comprising Type B gelatin, Bovine Type A gelatin or Fish Type A gelatin, wherein said soft gelatin capsules comprising Type B gelatin, Bovine Type A gelatin or Fish Type A gelatin contain a pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form, and wherein the shelf life is determined by storing said soft gelatin capsule comprising Porcine Type A gelatin and said soft gelatin capsules comprising Type B gelatin, Bovine Type A gelatin or Fish Type A gelatin for 3 months at a temperature of 40.degree. C.; disintegrating each of the capsules in water at 37.degree. C.; and measuring disintegration times of each capsule to determine the shelf life of each capsule.

2. The soft gelatin capsule as claimed in claim 1 wherein formulation comprises 5, 8, 11, 14, 17-eicosapentaenoic acid (or "EPA") in free acid form.

3. The soft gelatin capsule as claimed in claim 2 wherein EPA in free acid form is present in an amount of at least 50 wt % of the formulation.

4. The soft gelatin capsule as claimed in claim 2 wherein EPA in free acid form is present in an amount between from about 50 wt % to about 60 wt % of the formulation.

5. The soft gelatin capsule as claimed in claim 2 wherein EPA in free acid form is present in an amount of at least about 90 wt % of the formulation.

6. The soft gelatin capsule as claimed in claim 1 wherein the formulation comprises 4, 7, 10, 13, 16, 19-docosahexaenoic acid (or "DHA") in free acid form.

7. The soft gelatin capsule as claimed in claim 6 wherein DHA is present in an amount of between from about 20 wt % to about 30 wt % of the formulation.

8. The soft gelatin capsule as claimed in claim 1 comprising between from about 100 mg to about 2000 mg of said formulation.

9. The soft gelatin capsule as claimed in claim 8 comprising about 500 mg of said formulation.

10. The soft gelatin capsule as claimed in claim 9 comprising about 1000 mg of said formulation.
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