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Details for Patent: 5,558,880

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Details for Patent: 5,558,880

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)
Filing Date:Apr 28, 1994
Application Number:08/234,295
Claims:1. A method for preparing a solid, porous delivery matrix comprising a porous network of matrix material that disperses rapidly in water comprising the steps of:

(a) forming a matrix material dispersion containing from about 0.1% to about 7.5% matrix material by weight of the dispersion, the matrix material comprising a matrix forming agent and one or more amino acids having from about 2 to 12 carbon atoms; and

(b) subjecting the matrix material dispersion to lyophilization or solid-state dissolution to form the solid, porous delivery matrix.

2. A method for preparing a solid, porous delivery matrix comprising a porous network of matrix material that disperses rapidly in water comprising the steps of:

(a) forming a matrix material solution containing from about 0.1% to about 15% matrix material by weight of the solution, the matrix material comprising a matrix forming agent and one or more amino acids having from about 2 to 12 carbon atoms; and

(b) subjecting the matrix material solution to lyophilization or solid-state dissolution to form the solid, porous delivery matrix.

3. A method for preparing a solid, porous delivery matrix comprising a porous network of matrix material that disperses rapidly in water comprising the steps of:

(a) forming a matrix material dispersion or solution, the matrix material comprising gelatin and one or more amino acids having from about 2 to 12 carbon atoms; and

(b) subjecting the matrix material dispersion or solution to lyophilization or solid-state dissolution to form the solid, porous delivery matrix.

4. The method of claim 1 wherein one amino acid is glycine.

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

6. The method of claim 1 wherein the matrix material dispersion additionally comprises xanthan gum.

7. The method of claim 1 wherein the delivery matrix is formed by subjecting the matrix material dispersion to lyophilization.

8. The method of claim 1 wherein the delivery matrix is formed by subjecting the matrix material dispersion to solid-state dissolution.

9. The method of claim 1 wherein the matrix material dispersion additionally comprises an active agent.

10. The method of claim 1 wherein the matrix material dispersion additionally comprises a gas dispersed therethrough to form a foam delivery matrix.

11. The method of claim 7 wherein the matrix material dispersion additionally comprises an active agent in particulate form, particles of the active agent being coated with a coating agent.

12. The method of claim 11 wherein the coating agent is hydrophobic and is selected from the group consisting of fatty acids, glycerides, triglycerides and mixtures thereof.

13. The method of claim 1 wherein the matrix material dispersion comprises about 0.1% to about 3% of the matrix forming agent by weight.

14. The method of claim 1 wherein the matrix material dispersion comprises at least about 0.5% to the one or more amino acids by weight.

15. The method of claim 1 wherein the matrix material dispersion comprises at least about 0.5% mannitol by weight.

16. The method of claim 1 wherein the matrix material dispersion additionally comprises a cyclodextrin, magnesium trisilicate or magnesium aluminum silicate.

17. The method of claim 1 wherein the delivery matrix disperses in water in less than about 10 seconds.

18. The method of claim 1 wherein the matrix material dispersion contains from about 0.1% to about 4% matrix material by weight of the dispersion.

19. The method of claim 1 wherein the matrix material dispersion is a solution.

20. The method of claim 1 wherein the matrix material dispersion is an emulsion.

21. The method of claim 1 wherein the matrix material dispersion is a suspension.

22. The method of claim 1 comprising the additional step of:

(c) contacting the delivery matrix with a dispersion containing an active agent.

23. The method of claim 2 wherein one amino acid is glycine.

24. The method of claim 2 wherein the matrix forming agent is selected from the group consisting of gelatin, mannitol and mixtures thereof.

25. The method of claim 2 wherein the matrix material solution additionally comprises xanthan gum.

26. The method of claim 2 wherein the matrix material solution is subjected to lyophilization.

27. The method of claim 2 wherein the matrix material solution is subjected to solid-state dissolution.

28. The method of claim 2 wherein the matrix material solution additionally comprises an active agent.

29. The method of claim 2 wherein the matrix material solution additionally comprises a gas dispersed therethrough to form a foam delivery matrix.

30. The method of claim 26 wherein the matrix material solution additionally comprises an active agent in particulate form, particles of active agent being coated with a coating agent.

31. The method of claim 30 wherein the coating agent is hydrophobic and is selected from the group consisting of fatty acids, glycerides, triglycerides and mixtures thereof.

32. The method of claim 2 wherein the matrix material solution comprises about 0.1% to about 3% of the matrix forming agent by weight.

33. The method of claim 2 wherein the matrix material solution comprises about 0.5% to about 10% of the one or more amino acids by weight.

34. The method of claim 2 wherein the matrix material solution comprises about 0.5% to about 10% mannitol by weight.

35. The method of claim 2 wherein the matrix material solution additionally comprises a cyclodextrin, magnesium trisilicate, or magnesium aluminum silicate.

36. The method of claim 2 wherein the delivery matrix disperses in water in less than about 10 seconds.

37. The method of claim 2 wherein the matrix material solution contains from about 0.1% to about 7.5% matrix material by weight of the solution.

38. The method of claim 2 wherein the matrix material solution contains from about 0.1% to about 4% matrix material by weight of the solution.

39. The method of claim 2 comprising the additional step of:

(c) contacting the delivery matrix with a dispersion containing an active agent.

40. The method of claim 3 wherein one amino acid is glycine.

41. The method of claim 3 wherein the matrix material dispersion or solution additionally comprises mannitol.

42. The method of claim 3 wherein the matrix material dispersion or solution additionally comprises xanthan gum.

43. The method of claim 3 wherein the matrix material dispersion or solution comprises from about 0.1% to about 15% matrix material by weight of the dispersion or solution.

44. The method of claim 3 wherein the delivery matrix is formed by subjecting the matrix material dispersion or solution to lyophilization.

45. The method of claim 3 wherein the delivery matrix is formed by subjecting the matrix material dispersion or solution to solid-state dissolution.

46. The method of claim 3 wherein the matrix material dispersion or solution additionally comprises an active agent.

47. The method of claim 3 wherein the matrix material dispersion or solution additionally comprises a gas dispersed therethrough to form a foam dosage form.

48. The method of claim 44 wherein the matrix material dispersion or solution additionally comprises an active agent in particulate form, particles of active agent being coated with a coating agent.

49. The method of claim 48 wherein the coating agent is hydrophobic and is selected from the group consisting of fatty acids, glycerides, triglycerides and mixtures thereof.

50. The method claim 3 wherein the matrix material dispersion or solution comprises about 0.1% to about 3% of gelatin by weight.

51. The method of claim 3 wherein the matrix material dispersion or solution comprises about 0.5% to about 10% of the one or more amino acids by weight.

52. The method of claim 3 wherein the matrix material dispersion or solution comprises about 0.5 to about 10% mannitol by weight.

53. The method of claim 3 wherein the matrix material dispersion or solution additionally comprises a cyclodextrin, magnesium trisilicate or a magnesium aluminum silicate.

54. The method of claim 3 wherein the delivery matrix disperses in water in less than about 10 seconds.

55. The method of claim 3 wherein the matrix material dispersion or solution contains from about 0.1% to about 7.5% matrix material by weight.

56. The method of claim 3 wherein the matrix forming dispersion or solution contains from about 0.1% to 4% matrix material by weight.

57. The method of claim 3 wherein the matrix material dispersion or solution is a solution.

58. The method of claim 3 wherein the matrix material dispersion or solution is an emulsion.

59. The method of claim 3 wherein the matrix material dispersion or solution is a suspension.

60. The method of claim 3 comprising the additional step of:

(c) contacting the delivery matrix with a dispersion containing an active agent.
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