Stable formulations of antiplatelet agents, omega-3 fatty acids and amylose in soft gelatin capsules

1. A formulation consisting of capsules consisting of shell and

filling composition,

said shell consisting of gelatin and amylose or a starch containing between 50% and 70% amylose;

said filling composition consisting of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, omega-3 fatty acids or esters thereof, an organic acid and amylose or a starch containing between 50% and 70% amylose.

2. The formulation according to claim 1 wherein the omega-3 fatty acids comprise eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or esters thereof in the EPA:DHA ratio of 0.9 to 2.1.

3. The formulation according to claim 2 wherein the EPA:DHA ratio ranges from 0.9 to 2.1.

4. The formulation according to claim 3 containing 150 mg to 1200 mg per dosage unit of omega-3 acids.

5. A formulation consisting capsules consisting of

shell and

filling composition,

said shell consisting of gelatin, amylose or starch containing between 50% and 70% amylose and anhydrous citric acid in percentages ranging from 1% to 30%

said filling consisting of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, omega-3 fatty acids or esters thereof, an organic acid in percentages ranging from 1% to 30% and amylose or a starch containing between 50% and 70% amylose.

6. The formulation according to claim 1 characterized by a percentage of degradation products lower than 3% by weight after three months storage at 25° C./60% RH. 8.

7. A formulation consisting of capsules consisting of

shell and

filling composition,

said shell consisting of gelatin, an organic acid and amylose or starch containing between 50% and 70% amylose;

said filling composition consisting of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, omega-3 fatty acids or esters thereof, an organic acid, amylose or a starch containing between 50% and 70% amylose, and an oil suspension of crystals and pellets.

8. A formulation consisting of capsules consisting of

shell and

filling composition,

said shell consisting of gelatin, and amylose or starch containing between 50% and 70% amylose;

said filling composition consisting of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, omega-3 fatty acids or esters thereof and an organic acid.

9. A formulation consisting of capsules consisting of

shell and

filling composition,

said shell consisting of gelatin, an organic acid and amylose or starch containing between 50% and 70% amylose;

said filling composition consisting of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, omega-3 fatty acids or esters thereof, an organic acid, and an oil suspension of crystals and pellets.