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Last Updated: October 22, 2019

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Claims for Patent: 9,468,598

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Summary for Patent: 9,468,598
Title:Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient
Abstract: Dosage forms for oral administration of a PDE 4 inhibitor whose solubility is slight are described. They contain PVP as binder.
Inventor(s): Dietrich; Rango (Constance, DE), Eistetter; Klaus (Constance, DE), Ney; Hartmut (Constance, DE)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:13/874,065
Patent Claims: 1. A solid dosage form in tablet or pellet form for the oral administration of roflumilast, comprising: roflumilast--0.250 mg; lactose monohydrate--49.660 mg; corn starch--13.390 mg; polyvinylpyrrolidone having a weight average molecular weight of between 1,000,000 and 1,500,000-1.300 mg; and magnesium stearate--0.650 mg and wherein said dosage form provides immediate release of said roflumilast.

2. A solid dosage form in tablet or pellet form for the oral administration of roflumilast, comprising: roflumilast--0.500 mg; lactose monohydrate--49.660 mg; corn starch--13.390 mg; polyvinylpyrrolidone having a weight average molecular weight of between 1,000,000 and 1,500,000-1.300 mg; and magnesium stearate--0.650 mg and wherein said dosage form provides immediate release of said roflumilast.

3. The dosage form according to claim 1, wherein the dosage form is a tablet.

4. The dosage form according to claim 2, wherein the dosage form is a tablet.

5. A pharmaceutical dosage form, comprising a tablet of 0.500 mg roflumilast; 49.660 mg lactose monohydrate; 13.390 mg corn starch; 1.300 mg polyvinylpyrrolidone having a weight average molecular weight of between 1,000,000 and 1,500,000; and 0.650 mg magnesium stearate.

6. A solid dosage form in tablet or pellet form, for oral administration of roflumilast, comprising 0.25 mg of roflumilast; from 40 to 99% by weight, based on the finished dosage form of one or more fillers; from 2 to 35% by weight, based on the finished dosage form of one or more disintegrants; polyvinylpyrrolidone having a weight average molecular weight of between 1,000,000 and 1,500,000; and a lubricant and wherein said dosage form provides immediate release of said roflumilast.

7. A solid dosage form in tablet or pellet form, for oral administration of roflumilast, comprising 0.5 mg of roflumilast; from 40 to 99% by weight, based on the finished dosage form of one or more fillers; from 2 to 35% by weight, based on the finished dosage form of one or more disintegrants; polyvinylpyrrolidone having a weight average molecular weight of between 1,000,000 and 1,500,000; and a lubricant and wherein said dosage form provides immediate release of said roflumilast.

8. A solid dosage form in tablet or pellet form, for oral administration of roflumilast, comprising 0.5 mg of roflumilast; from 40 to 99% by weight, based on the finished dosage form of one or more fillers; from 2 to 35% by weight, based on the finished dosage form of one or more disintegrants; polyvinylpyrrolidone; and a lubricant, and wherein said dosage form provides immediate release of said roflumilast.

9. The solid dosage form of claim 8, wherein said polyvinylpyrrolidone is selected from the group consisting of polyvinylpyrrolidone having a weight average molecular weight of between 28,000 and 34,000; polyvinylpyrrolidone having a weight average molecular weight of between 44,000 and 54,000; and polyvinylpyrrolidone having a weight average molecular weight of between 1,000,000 and 1,500,000.

10. The dosage form according to claim 7, wherein the proportion of polyvinylpyrrolidone is from 1 to 5% by weight, based on the finished dosage form.

11. The dosage form according to claim 10, wherein the proportion of polyvinylpyrrolidone is from 2 to 3% by weight, based on the finished dosage form.

12. The dosage form according to claim 10, wherein the proportion of polyvinylpyrrolidone is from 1.98 to 3% by weight, based on the finished dosage form.

13. The dosage form according to claim 7, wherein the filler is selected from the group consisting of sugar alcohols, starches, saccharides and mixtures thereof.

14. The dosage form according to claim 7, wherein the filler is selected from the group consisting of corn starch, microcrystalline cellulose, lactose and mixtures thereof.

15. The dosage form according to claim 7, wherein the filler includes corn starch and lactose.

16. The dosage form according to claim 7, wherein the lubricant is selected from the group consisting of sodium stearyl fumarate, magnesium stearate, calcium stearate, stearic acid, talc and colloidal anhydrous silica.

17. The dosage form according to claim 16, wherein the lubricant is magnesium stearate.

18. The dosage form according to claim 8, wherein the proportion of polyvinylpyrrolidone is from 1 to 5% by weight, based on the finished dosage form.

19. The dosage form according to claim 18, wherein the proportion of polyvinylpyrrolidone is from 2 to 3% by weight, based on the finished dosage form.

20. The dosage form according to claim 19, wherein the proportion of polyvinylpyrrolidone is from 1.98 to 3% by weight, based on the finished dosage form.

21. The dosage form according to claim 8, wherein the filler is selected from the group consisting of sugar alcohols, starches, saccharides and mixtures thereof.

22. The dosage form according to claim 8, wherein the filler is selected from the group consisting of corn starch, microcrystalline cellulose, lactose and mixtures thereof.

23. The dosage form according to claim 8, wherein the filler includes corn starch and lactose.

24. The dosage form according to claim 8, wherein the lubricant is selected from the group consisting of sodium stearyl fumarate, magnesium stearate, calcium stearate, stearic acid, talc and colloidal anhydrous silica.

25. The dosage form according to claim 24, wherein the lubricant is magnesium stearate.

26. The dosage form according to claim 9, wherein the proportion of polyvinylpyrrolidone is from 1 to 5% by weight, based on the finished dosage form.

27. The dosage form according to claim 26, wherein the proportion of polyvinylpyrrolidone is from 2 to 3% by weight, based on the finished dosage form.

28. The dosage form according to claim 27, wherein the proportion of polyvinylpyrrolidone is from 1.98 to 3% by weight, based on the finished dosage form.

29. The dosage form according to claim 9, wherein the filler is selected from the group consisting of sugar alcohols, starches, saccharides and mixtures thereof.

30. The dosage form according to claim 9, wherein the filler is selected from the group consisting of corn starch, microcrystalline cellulose, lactose and mixtures thereof.

31. The dosage form according to claim 9, wherein the filler includes corn starch and lactose.

32. The dosage form according to claim 9, wherein the lubricant is selected from the group consisting of sodium stearyl fumarate, magnesium stearate, calcium stearate, stearic acid, talc and colloidal anhydrous silica.

33. The dosage form according to claim 32, wherein the lubricant is magnesium stearate.

34. The dosage form according to claim 6, wherein the proportion of polyvinylpyrrolidone is from 1 to 5% by weight, based on the finished dosage form.

35. The dosage form according to claim 34, wherein the proportion of polyvinylpyrrolidone is from 2 to 3% by weight, based on the finished dosage form.

36. The dosage form according to claim 34, wherein the proportion of polyvinylpyrrolidone is from 1.98 to 3% by weight, based on the finished dosage form.

37. The dosage form according to claim 6, wherein the filler is selected from the group consisting of sugar alcohols, starches, saccharides and mixtures thereof.

38. The dosage form according to claim 6, wherein the filler is selected from the group consisting of corn starch, microcrystalline cellulose, lactose and mixtures thereof.

39. The dosage form according to claim 6, wherein the filler includes corn starch and lactose.

40. The dosage form according to claim 6, wherein the lubricant is selected from the group consisting of sodium stearyl fumarate, magnesium stearate, calcium stearate, stearic acid, talc and colloidal anhydrous silica.

41. The dosage form according to claim 40, wherein the lubricant is magnesium stearate.

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