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Claims for Patent: 6,015,577

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Claims for Patent: 6,015,577

Title: Pharmaceutical compositions containing dipyridamole or mopidamol and acetylsalicylic acid or the physiologically acceptable salts thereof, processes for preparing them and their use in treating clot formation
Abstract:The specification describes a pharmaceutical combination consisting of dipyridamole or mopidamol and acetylsalicylic acid or the physiologically acceptable salts thereof, processes for preparing this pharmaceutical combination and the use thereof for the controlled prevention of clot formation.
Inventor(s): Eisert; Wolfgang (Biberach, DE), Gruber; Peter (Biberach, DE)
Assignee: Thomae GmbH; Dr. Karl (Biberach an der Riss, DE)
Application Number:08/421,351
Patent Claims: 1. A pharmaceutical composition for oral administration comprising:

a first component selected from the group consisting of dipyridamole, and the pharmaceutically acceptable salts thereof; and

a second component selected from the group consisting of acetylsalicylic acid and the pharmaceutically acceptable salts thereof;

said first and second components being present in a weight ratio in the range between 8:1 and 100:1;

a pharmaceutically acceptable acid excipient formulated together with said first component in the form of granules provided with a coating made up of 50 to 100% of lacqueurs which are insoluble in acid but soluble in intestinal juices and 50 to 0% of lacqueurs which are insoluble in both gastric and intestinal juices, and said acid excipient being in a ratio of at least one equivalent of said acid excipient to 1 mol of said first component;

said second component being present in the form of a tablet; and

all components being contained together within a capsule.

2. A pharmaceutical composition for oral administration comprising:

a first component selected from the group consisting of dipyridamole, and the pharmaceutically acceptable salts thereof; and

a second component selected from the group consisting of acetylsalicylic acid and the pharmaceutically acceptable salts thereof;

said first and second components being present in a weight ratio in the range between 8:1 and 100:1;

a pharmaceutically acceptable acid excipient formulated together with said first component in the form of pellets provided with a coating made up of 50 to 100% of lacqueurs which are insoluble in acid but soluble in intestinal juices and 50 to 0% of lacqueurs which are insoluble in both gastric and intestinal juices, and said acid excipient being in a ratio of at least one equivalent of said acid excipient to 1 mol of said first component;

said second component being present in the form of a tablet; and

all components being contained together within a capsule.

3. The pharmaceutical composition of claim 1 wherein said acid excipient is selected from fumaric acid, tartaric acid, citric acid, succinic acid and malic acid.

4. The pharmaceutical composition of claim 2 wherein said acid excipient is selected from fumaric acid, tartaric acid, citric acid, succinic acid and malic acid.

5. The pharmaceutical composition of claim 1 wherein said acid excipient is selected from fumaric acid and tartaric acid.

6. The pharmaceutical composition of claim 2 wherein said acid excipient is selected from fumaric acid and tartaric acid.

7. The pharmaceutical composition of claim 1 wherein the lacqueurs which are insoluble in acid but soluble in intestinal juices are selected from the group consisting of methacrylic acid/methacrylic acid ester copolymers, hydroxypropylmethylcellulose phthalate, cellulose acetate phthalate, ethylcellulose phthalate, hydroxypropylmethylcellulose succinate, cellulose acetate succinate, hydroxypropylmethylcellulose hexahydrophthalate, cellulose acetate hexahydrophthalate, hydroxypropylmethylcellulose trimellitate and the mixtures thereof, and the lacqueurs which are insoluble in both intestinal and gastric juices are based on lacqueurs selected from the group consisting of acrylate, methacrylate and mixtures thereof with up to 14% by weight of ethylcellulose.

8. The pharmaceutical composition of claim 2 wherein the lacqueurs which are insoluble in acid but soluble in intestinal juices are selected from the group consisting of methacrylic acid/methacrylic acid ester copolymers, hydroxypropylmethylcellulose phthalate, cellulose acetate phthalate, ethylcellulose phthalate, hydroxypropylmethylcellulose succinate, cellulose acetate succinate, hydroxypropylmethylcellulose hexahydrophthalate, cellulose acetate hexahydrophthalate, hydroxypropylmethylcellulose trimellitate and the mixtures thereof, and the lacqueurs which are insoluble in both intestinal and gastric juices are based on lacqueurs selected from the group consisting of acrylate, methacrylate and mixtures thereof with up to 14% by weight of ethylcellulose.

9. The pharmaceutical composition of claim 1 wherein the coating of the granules is made up of methacrylic acid/methacrylic acid ester copolymer and hydroxypropylmethylcellulose phthalate in a weight ratio of 85:15 to 50:50, and the coating of the tablet comprises sucrose.

10. The pharmaceutical composition of claim 2 wherein the coating of the pellets is made up of methacrylic acid/methacrylic acid ester copolymer and hydroxypropylmethylcellulose phthalate in a weight ratio of 85:15 to 50:50, and the coating of the tablet comprises sucrose.

11. The pharmaceutical composition of claim 1 wherein said first component is present in an amount between 75 and 400 mg and said second component is present in an amount of 5 to 80 mg.

12. The pharmaceutical composition of claim 2 wherein said first component is present in an amount between 75 and 400 mg and said second component is present in an amount of 5 to 80 mg.

13. A pharmaceutical composition for oral administration comprising:

(a) a first component selected from dipyridamole and the pharmaceutically acceptable salts thereof; and

(b) a second component selected from acetylsalicylic acid and the pharmaceutically acceptable salts thereof; and,

wherein the quantities of the first and second components are adjusted so that the weight ratio between them is between 8:1 and 100:1.

14. A pharmaceutical composition for oral administration comprising:

(a) dipyridamole; and,

(b) acetylsalicylic acid;

wherein the quantities of dipyridamole and acetylsalicylic acid are adjusted so that the final dosage form comprises 200 mg of dipyridamole and 25 mg of acetylsalicylic acid, and so that the weight ratio between them is 8:1.

15. A pharmaceutical composition for oral administration comprising:

a) dipyridamole pellets, each such pellet having a core consisting of a pharmaceutically acceptable acid excipient, a first coating surrounding the core comprising dipyridamole and polyvinylpyrrolidone, and a lacquer coating, on top of the first coating, comprising methacrylic acid/methylmethacrylate copolymer and hydoxypropylmethylcellulose phthalate;

b) an acetylsalicylic acid tablet, comprising an acetylsalicylic acid core and a coating comprising sucrose; and,

c) a capsule, for containing the dipyidamole pellets and the acetylsalicylic acid tablet;

the quantities of the various components being adjusted so that the final dosage form comprises about 25 mg of acetylsalicylic acid and about 200 mg of dipyridamole.

16. A method for inhibiting the formation of venous and arterial blood clots, which comprises administering to a patient requiring inhibition of venous or arterial clot formation, a first drug selected from the group consisting of dipyridamole and the pharmaceutically acceptable salts thereof; and a second drug selected from the group consisting of acetylsalicylic acid and the pharmaceutically acceptable salts thereof; with said first and second drugs being administered in a weight ratio in the range between 8:1 and 100:1.

17. A method for inhibiting the occurrence of temporary ischaemic episodes which consists of carrying out the method of claim 16.

18. A method for inhibiting the occurrence of strokes of the type caused by a blood clot which consists of carrying out the method of claim 16.

19. A method for inhibiting the occurrence of cardiac infarctions which consists of carrying out the method of claim 16.

20. The method of claim 16 wherein the patient suffers from arteriosclerosis.
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