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Claims for Patent: 5,648,093

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Claims for Patent: 5,648,093

Title: Pharmaceutical and other dosage forms
Abstract:A fast dissolving, solid dosage form defined by a matrix containing gelatin, pectin and/or soy fiber protein and one or more amino acids having from about 2 to 12 carbon atoms is disclosed.
Inventor(s): Gole; Dilip J. (Ann Arbor, MI), Levinson; R. Saul (Chesterfield, MO), Wilkinson; Paul K. (Ann Arbor, MI), Davies; J. Desmond (Grosse Pointe Farms, MI)
Assignee: Janssen Pharmaceutica Inc. (Piscataway, NJ)
Application Number:08/447,253
Patent Claims: 1. A solid dosage form comprising a porous network of a matrix composition that disperses rapidly in water, the dosage form being prepared by forming a matrix composition dispersion containing from about 0. 1% to about 7.5% of the matrix composition by weight of the dispersion and subjecting the matrix composition dispersion to lyophilization or solid-state dissolution, the matrix composition comprising a matrix forming agent and one or more amino acids having from about 2 to 12 carbon atoms.

2. The dosage form of claim 1 wherein one amino acid is glycine.

3. The dosage form of claim 1 wherein the matrix forming agent is selected from the group consisting of gelatin, mannitol and mixtures thereof.

4. The dosage form of claim 1 additionally comprising xanthan gum.

5. The dosage form of claim 1 wherein the dosage form is formed by subjecting the matrix composition dispersion to lyophilization.

6. The dosage form of claim 1 wherein the dosage form is formed by subjecting the matrix composition dispersion to solid-state dissolution.

7. The dosage form of claim 1 additionally comprising an active agent.

8. The dosage form of claim 1 wherein the matrix composition dispersion additionally comprises a gas dispersed therethrough to form a foam dosage form.

9. The dosage form of claim 5 wherein the dosage form additionally comprises an active agent in particulate form, particles of the active agent being coated with a coating agent.

10. The dosage form of claim 9 wherein the coating agent is hydrophobic and is selected from the group consisting of fatty acids, glycerides, triglycerides and mixtures thereof.

11. The dosage form of claim 1 wherein the matrix composition dispersion comprises about 0.1% to about 3% of the matrix forming agent by weight.

12. The dosage form of claim 1 wherein the matrix composition dispersion comprises at least about 0.5% of the one or more amino acids by weight.

13. The dosage form of claim 1 wherein the matrix composition dispersion comprises at least about 0.5% mannitol by weight.

14. The dosage form of claim 1 additionally comprising a cyclodextrin, magnesium trisilicate or magnesium aluminum silicate.

15. The dosage form of claim 1 wherein the dosage form disperses in water in less than about 10 seconds.

16. The dosage form of claim 1 wherein the matrix composition dispersion contains from about 0.1% to about 4% of the matrix composition by weight of the dispersion.

17. The dosage form of claim 1 wherein the matrix composition dispersion is a solution.

18. The dosage form of claim 1 wherein the matrix composition dispersion is an emulsion.

19. The dosage form of claim 1 wherein the matrix composition dispersion is a suspension.

20. A solid dosage form comprising a porous network of a matrix composition that disperses rapidly in water, the dosage form being prepared by forming a matrix composition solution containing from about 0.1% to about 15% of the matrix composition by weight of the solution and subjecting the matrix composition solution to lyophilization or solid-state dissolution, the matrix composition comprising a matrix forming agent and one or more amino acids having from about 2 to 12 carbon atoms.

21. The dosage form of claim 20 wherein one amino acid is glycine.

22. The dosage form of claim 20 wherein the matrix forming agent is selected from the group consisting of gelatin, mannitol and mixtures thereof.

23. The dosage form of claim 20 additionally comprising xanthan gum.

24. The dosage form of claim 20 wherein the matrix composition solution is subjected to lyophilization.

25. The dosage form of claim 20 wherein the matrix composition solution is subjected to solid-state dissolution.

26. The dosage form of claim 20 additionally comprising an active agent.

27. The dosage form of claim 20 wherein the matrix composition solution additionally comprises a gas dispersed therethrough to form a foam dosage form.

28. The dosage form of claim 24 wherein the dosage form additionally comprises an active agent in particulate form, particles of active agent being coated with a coating agent.

29. The dosage form of claim 28 wherein the coating agent is hydrophobic and is selected from the group consisting of fatty acids, glycerides, triglycerides and mixtures thereof.

30. The dosage form of claim 20 wherein the matrix composition solution comprises about 0.1% to about 3% of the matrix forming agent by weight.

31. The dosage form of claim 20 wherein the matrix composition solution comprises about 0.5% to about 10% of the one or more amino acids by weight.

32. The dosage form of claim 20 wherein the matrix composition solution comprises about 0.5% to about 10% mannitol by weight.

33. The dosage form of claim 20 additionally comprising a cyclodextrin, magnesium trisilicate, or magnesium aluminum silicate.

34. The dosage form of claim 20 wherein the dosage form disperses in water in less than about 10 seconds.

35. The dosage form of claim 20 wherein the matrix composition solution contains from about 0.1% to about 7.5% of the matrix composition by weight of the solution.

36. The dosage form of claim 20 wherein the matrix composition solution contains from about 0.1% to about 4% of the matrix composition by weight of the solution.

37. A solid dosage form comprising a porous network of a matrix composition that disperses rapidly in water, the matrix composition comprising gelatin and one or more amino acids having from about 2 to 12 carbon atoms.

38. The dosage form of claim 37 wherein one amino acid is glycine.

39. The dosage form of claim 37 wherein the dosage form additionally comprises mannitol.

40. The dosage form of claim 37 wherein the dosage form additionally comprises xanthan gum.

41. The dosage form of claim 37 wherein the matrix composition dispersion containing from about 0.1% to about 15% of the matrix composition by weight of the dispersion.

42. The dosage form of claim 41 wherein the dosage form is formed by subjecting the matrix composition dispersion to lyophilization.

43. The dosage form of claim 41 wherein the dosage form is formed by subjecting the matrix composition dispersion to solid-state dissolution.

44. The dosage form of claim 37 additionally comprising an active agent.

45. The dosage form of claim 41 wherein the matrix composition dispersion additionally comprises a gas dispersed therethrough to form a foam dosage form.

46. The dosage form of claim 42 wherein the dosage form additionally comprises an active agent in particulate form, particles of active agent being coated with a coating agent.

47. The dosage form of claim 46 wherein the coating agent is hydrophobic and is selected from the group consisting of fatty acids, glycerides, triglycerides and mixtures thereof.

48. The dosage form claim 41 wherein the matrix composition dispersion comprises about 0.1% to about 3% of gelatin by weight.

49. The dosage form of claim 41 wherein the matrix composition dispersion comprises about 0.5% to about 10% of the one or more amino acids by weight.

50. The dosage form of claim 41 wherein the matrix composition dispersion comprises about 0.5 to about 10% mannitol by weight.

51. The dosage form of claim 37 additionally comprising a cyclodextrin, magnesium trisilicate or a magnesium aluminum silicate.

52. The dosage form of claim 37 wherein the dosage form disperses in water in less than about 10 seconds.

53. The dosage form of claim 41 wherein the matrix composition dispersion contains from about 0.1% to about 7.5% of the matrix composition by weight.

54. The dosage form of claim 41 wherein the matrix composition dispersion contains from about 0.1% to about 4% of the matrix composition by weight.

55. The dosage form of claim 41 wherein the matrix material dispersion is a solution.

56. The dosage form of claim 41 wherein the matrix material dispersion is an emulsion.

57. The dosage form of claim 41 wherein the matrix material dispersion is a suspension.
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