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Claims for Patent: 6,974,595

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Claims for Patent: 6,974,595

Title: Pharmaceutical compositions based on Diclofenae
Abstract:New pharmaceutical compositions for oral use containing Diclofenac together with alkali metal bicarbonates in amounts of from 20 to 80 by weight with respect to Diclofenac are described. These compositions are entirely palatable and free from any unpleasant taste or other side effects; in particular, these formulations permit to obtain in human patients higher C.sub.max of the active principle and shorter T.sub.max together with a lower coefficient of variation.
Inventor(s): Reiner; Alberto (Como, IT), Reiner; Giorgio (Como, IT)
Assignee: ProEthic Pharmaceuticals, Inc. (Montgomery, AL)
Application Number:09/524,747
Patent Claims: 1. A method for obtaining an average T.sub.max of diclofenac in a human patient between 5 and 30 minutes after administering said diclofenac to said patient, said average T.sub.max having a coefficient of variation (CV%) less than about 70%, comprising orally administering a diclofenac formulation to said patient, wherein said diclofenac formulation comprises diclofenac in acid and/or salt form together with an alkali metal bicarbonate selected from the group consisting of sodium bicarbonate, potassium bicarbonate and mixtures thereof, wherein said alkali metal bicarbonate is present in an amount of from about 20 to about 80% by weight based on the weight of said diclofenac, wherein said diclofenac formulation further contains a flavoring substance selected from the group consisting of mint, aniseed, ammonium glycyrrhizinate and mixtures thereof whereby palatability and astringency effects are eliminated, and wherein said diclofenac formulation is selected from: a. a powder formulation dissolved or dispersed in water; and b. a fast release layer present in a two layered diclofenac tablet that comprises a slow release layer and a fast release layer.

2. The method according to of claim 1 where said average T.sub.max is reached 13-27 minutes after said administration.

3. A The method according to of claim 1 wherein said alkali metal bicarbonate is present in an amount of from about 40 to about 80% by weight based on the weight of said diclofenac.

4. The method of claim 1 wherein said diclofenac formulation comprises from about 10 to about 60 mg. of diclofenac in its potassium salt form.

5. The method of claim 1 wherein said diclofenac formulation comprises from about 10 to about 60 mg. of diclofenac in its sodium salt form.

6. The method of claim 1 wherein said alkali metal bicarbonate is sodium bicarbonate.

7. The method of claim 1 wherein said alkali metal bicarbonate is potassium bicarbonate.

8. The method of claim 1 wherein said diclofenac formulation is said powder formulation.

9. The method of claim 1 wherein said diclofenac formulation is said fast release layer.

10. The method of claim 1 wherein said diclofenac formulation is said powder formulation, and said diclofenac formulation comprises about 50 mg. of diclofenac potassium salt.

11. The method of claim 1 wherein said diclofenac formulation is said fast release layer, said diclofenac formulation comprises about 15 mg. of diclofenac potassium salt, and said slow release layer comprises about 70 mg. of diclofenac potassium salt.

12. The method of claim 1 wherein said diclofenac formulation comprises about 50 mg. of diclofenac potassium salt and from about 22 to about 24 mg. of potassium bicarbonate.

13. The method of claim 1 wherein said diclofenac formulation comprises about 50 mg. of diclofenac and said administration achieves an average C.sub.max of from about 1700 to about 2300 ng/ml.

14. A method of treating a human patient with diclofenac comprising orally administering a diclofenac formulation to said patient, wherein said diclofenac formulation comprises diclofenac in acid and/or salt form together with one or more alkali metal carbonates or bicarbonates, wherein said one or more alkali metal carbonates or bicarbonates is present in an amount of greater than about 20% by weight based on the weight of said diclofenac, and wherein said diclofenac formulation is selected from: a. a powder formulation dissolved or dispersed in water; and b. a fast release layer present in a two layered diclofenac tablet that comprises a slow release layer and a fast release layer.

15. The method of claim 14 wherein an average T.sub.max of diclofenac is reached between 5 and 30 minutes after orally administering said diclofenac formulation.

16. The method of claim 14 wherein an average T.sub.max of diclofenac is reached between 5 and 30 minutes after orally administering said diclofenac formulation, said average T.sub.max having a coefficient of variation (CV%) less than about 70%.

17. The method of claim 14 wherein said diclofenac formulation comprises about 50 mg. of diclofenac and said administering achieves an average C.sub.max of from about 1700 to about 2300 ng/ml.

18. The method of claim 14 wherein said diclofenac formulation comprises from about 10 to about 60 mg. of diclofenac in its potassium salt form.

19. The method of claim 14 wherein said diclofenac formulation comprises from about 10 to about 60 mg. of diclofenac in its sodium salt form.

20. The method of claim 14 wherein said one or more alkali metal carbonates or bicarbonates is present in an amount of from about 40 to about 80% by weight based on the weight of diclofenac.

21. The method of claim 14 wherein said diclofenac formulation comprises sodium bicarbonate.

22. The method of claim 14 wherein said diclofenac formulation comprises potassium bicarbonate.

23. The method of claim 14 wherein said diclofenac formulation is said powder formulation.

24. The method of claim 14 wherein said diclofenac formulation is said fast release layer.

25. The method of claim 14 wherein said diclofenac formulation is said powder formulation, and said diclofenac formulation comprises about 50 mg. of diclofenac potassium salt.

26. The method of claim 14 wherein said diclofenac formulation is said fast release layer, said diclofenac formulation comprises about 15 mg. of diclofenac potassium salt, and said slow release layer comprises about 70 mg. of diclofenac potassium salt.

27. The method of claim 14 wherein said diclofenac formulation comprises about 50 mg. of diclofenac potassium salt and from about 22 to about 24 mg. of potassium bicarbonate.

28. A method for obtaining an average T.sub.max of diclofenac in a human patient between 5 and 30 minutes after administration comprising orally administering a diclofenac formulation to said patient, wherein said diclofenac formulation comprises diclofenac in acid and/or salt form, and wherein said diclofenac formulation is selected from: a. a powder formulation dissolved or dispersed in water; and b. a fast release layer present in a two layered diclofenac tablet that comprises a slow release layer and a fast release layer.

29. The method of claim 28 wherein said average T.sub.max has a coefficient of variation (CV%) less than about 70%.

30. The method of claim 28 wherein said average T.sub.max is reached 13-27 minutes after administration.

31. The method of claim 28 wherein said diclofenac formulation comprises about 50 mg. of diclofenac and said administration achieves an average C.sub.max of from about 1700 to about 2300 ng/ml.

32. The method of claim 28 wherein said diclofenac formulation is said powder formulation.

33. The method of claim 28 wherein said diclofenac formulation is said fast release layer.

34. A method for obtaining an average T.sub.max of diclofenac in a human patient between 5 and 30 minutes after administration comprising orally administering a diclofenac formulation to said patient, wherein said diclofenac formulation comprises diclofenac in acid and/or salt form and means for enhancing said average T.sub.max of said diclofenac, and wherein said diclofenac formulation is selected from: a. a powder formulation dissolved or dispersed in water; and b. a fast release layer present in a two layered diclofenac tablet that comprises a slow release layer and a fast release layer.

35. The method of claim 34 wherein said average T.sub.max has a coefficient of variation (CV%) less than about 70%.

36. The method of claim 34 wherein said T.sub.max of diclofenac is reached 13-27 minutes after administration.

37. The method of claim 34 wherein said diclofenac formulation comprises about 50 mg. of diclofenac and said administration achieves an average C.sub.max of from about 1700 to about 2300 ng/ml.

38. The method of claim 34 wherein said means for enhancing said average T.sub.max of said diclofenac comprises one or more alkali metal carbonates or bicarbonates.

39. The method of claim 34 wherein said means for enhancing said average T.sub.max of said diclofenac comprises one or more alkali metal carbonates or bicarbonates in an amount of from about 20 to about 80% by weight based on the weight of said diclofenac.

40. The method of claim 34 wherein said means for enhancing said average T.sub.max of said diclofenac comprises sodium bicarbonate.

41. The method of claim 34 wherein said means for enhancing said average T.sub.max of said diclofenac comprises potassium bicarbonate.

42. The method of claim 34 wherein said diclofenac formulation is said powder formulation.

43. The method of claim 34 wherein said diclofenac formulation is said fast release layer.
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