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Claims for Patent: 6,986,904

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Claims for Patent: 6,986,904

Title:Formulation
Abstract:A new metered unit dose comprising 40 .mu.g or less of budesonide is disclosed as well as a formulation thereof and the use thereof for the treatment of conditions in the nose.
Inventor(s): Nilsson; Hans (Lund, SE), Santesson; Gordon (Horby, SE)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:10/716,357
Patent Claims: 1. A unit dose of a therapeutic composition comprising about 16 to about 40 .mu.g budesonide, wherein the budesonide (a) is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, and (b) is suspended in an aqueous medium.

2. A therapeutic method of treating an inflammatory condition of the upper respiratory tract, the method comprising metering into the nose of a mammal in need thereof a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses in a metered amount of about 32 .mu.g budesonide per unit dose, wherein each unit dose comprises finely divided budesonide particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, the particles being suspended in an aqueous medium.

3. The therapeutic method of claim 2, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

4. The therapeutic method of claim 2, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

5. The therapeutic method of claim 2, wherein the amount of budesonide is about 256 .mu.g per day.

6. The therapeutic method of claim 2, wherein the concentration of budesonide in each unit dose is about 0.6 to 0.7 mg/ml.

7. A unit dose of a therapeutic composition consisting of (a) about 32 .mu.g budesonide; and (b) other ingredients comprising a mixture consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the mixture at about 0.5 to 2.5% by weight of the therapeutic composition; dextrose; Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition; disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, wherein the budesonide is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium, said therapeutic composition being suitable for nasal administration to a mammal in a single dose.

8. The unit dose of claim 7, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

9. The unit dose of claim 7, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

10. A therapeutic method of treating an inflammatory condition of the upper respiratory tract, the method comprising metering into the nose of a mammal in need thereof a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, wherein each unit dose consists of about 32 .mu.g budesonide and other ingredients, the other ingredients comprising a mixture consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the mixture at about 0.5 to 2.5% by weight of the therapeutic composition; dextrose; Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition; disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, wherein the budesonide is in the form of finely divided particles, at least 90% having a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium.

11. The therapeutic method of claim 10, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

12. The therapeutic method of claim 10, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

13. The therapeutic method of claim 10, wherein the concentration of budesonide in each unit dose is about 0.6 to 0.7 mg/ml.

14. A therapeutic method of treating or preventing an inflammatory condition of the upper respiratory tract, the method comprising administering into a nostril of a mammal in need thereof a metered unit dose, the active ingredient of which consists of about 32 .mu.g of budesonide formulated as finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium.

15. The therapeutic method of claim 14, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

16. The therapeutic method of claim 14, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

17. The therapeutic method of claim 14, wherein the concentration of budesonide in the unit dose is about 0.6 to 0.7 mg/ml.

18. A therapeutic method of treating an inflammatory condition of the upper respiratory tract, the method comprising metering into the nose of a mammal in need thereof a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, the active ingredient of each unit dose consisting of about 32 .mu.g budesonide formulated as finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium.

19. The therapeutic method of claim 18, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

20. The therapeutic method of claim 18, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

21. The therapeutic method of claim 18, wherein the concentration of budesonide in each unit dose is about 0.6 to 0.7 mg/ml.

22. A unit dose of a therapeutic composition, the active ingredient of which consists of about 32 .mu.g budesonide, wherein the therapeutic composition additionally comprises a mixture consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the mixture at about 0.5 to 2.5% by weight of the therapeutic composition; dextrose; Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition; disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, wherein the budesonide is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium, said therapeutic composition being suitable for nasal administration to a mammal in a single dose.

23. The unit dose of claim 22, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

24. The unit dose of claim 22, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

25. The unit dose of claim 22, wherein the concentration of budesonide in the unit dose is about 0.6 to 0.7 mg/ml.

26. A unit dose of a therapeutic composition comprising about 32 .mu.g budesonide, wherein the budesonide is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, and is suspended in an aqueous medium having a pH between 3.5 and 5.0, said composition being suitable for administration to a mammal in a single dose, wherein the composition includes no more than about 32 .mu.g budesonide.

27. The unit dose of claim 26, wherein the pH of the aqueous medium is between 4.2 and 4.6.

28. The unit dose of claim 26, wherein the composition is suitable for nasal administration to a mammal.

29. The unit dose of claim 26, wherein the concentration of budesonide in the composition is about 0.6 to 0.7 mg/ml.

30. The unit dose of claim 26, further comprising one or more pharmaceutically acceptable additives selected from the group consisting of thickening agents, isotonicity agents, surfactants, chelating agents, and preservatives.

31. A therapeutic method of treating or preventing an inflammatory condition of the upper respiratory tract, the method comprising administering into a nostril of a mammal in need thereof a metered unit dose of finely divided budesonide particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0, wherein said metered unit dose consists of about 32 .mu.g budesonide and one or more ingredients other than budesonide.

32. The therapeutic method of claim 31, wherein the pH of the aqueous medium is between 4.2 and 4.6.

33. The therapeutic method of claim 31, wherein the condition to be treated is seasonal allergic rhinitis.

34. The therapeutic method of claim 31, wherein the condition to be treated is perennial allergic rhinitis.

35. The therapeutic method of claim 31, wherein the condition to be treated is perennial non-allergic rhinitis.

36. The therapeutic method of claim 31, wherein the condition to be treated is chronic sinusitis.

37. The therapeutic method of claim 31, wherein the condition to be treated is recurrent sinusitis.

38. The therapeutic method of claim 31, wherein the condition to be treated is nasal polyps.

39. The therapeutic method of claim 31, wherein the concentration of budesonide in the unit dose is about 0.6 to 0.7 mg/ml.

40. A therapeutic method of treating an inflammatory condition of the upper respiratory tract, the method comprising metering into the nose of a mammal in need thereof a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses in a metered amount of about 32 .mu.g budesonide per unit dose, wherein each unit dose comprises finely divided budesonide particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0.

41. The therapeutic method of claim 40, wherein the pH of the aqueous medium is between 4.2 and 4.6.

42. A therapeutic method according to claim 40, wherein the amount of budesonide is about 256 .mu.g per day.

43. The therapeutic method of claim 40, wherein the concentration of budesonide in each unit dose is about 0.6 to 0.7 mg/ml.

44. A unit dose of a therapeutic composition consisting of (a) about 32 .mu.g budesonide; and (b) other ingredients comprising a mixture consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the mixture at about 0.5 to 2.5% by weight of the therapeutic composition; dextrose; Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition; disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, wherein the budesonide is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0, said therapeutic composition being suitable for nasal administration to a mammal in a single dose.

45. The unit dose of claim 44, wherein the pH of the aqueous medium is between 4.2 and 4.6.

46. A therapeutic method of treating an inflammatory condition of the upper respiratory tract, the method comprising metering into the nose of a mammal a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, wherein each unit dose consists of about 32 .mu.g budesonide and other ingredients, the other ingredients comprising a mixture consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the mixture at about 0.5 to 2.5% by weight of the therapeutic composition; dextrose; Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition; disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, wherein the budesonide is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0.

47. The therapeutic method of claim 46, wherein the pH of the aqueous medium is between 4.2 and 4.6.

48. The therapeutic method of claim 46, wherein the concentration of budesonide in each unit dose is about 0.6 to 0.7 mg/ml.

49. A unit dose of a therapeutic composition, the active ingredient of which consists of about 32 .mu.g budesonide formulated as finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0, said composition being suitable for administration to a mammal in a single dose.

50. The unit dose of claim 49, wherein the pH of the aqueous medium is between 4.2 and 4.6.

51. The unit dose of claim 49, wherein the concentration of budesonide in the composition is about 0.6 to 0.7 mg/ml.

52. A therapeutic method of treating or preventing an inflammatory condition of the upper respiratory tract, the method comprising administering into a nostril of a mammal a metered unit dose, the active ingredient of which consists of about 32 .mu.g of budesonide formulated as finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium, having a pH between 3.5 and 5.0.

53. The therapeutic method of claim 52, wherein the pH of the aqueous medium is between 4.2 and 4.6.

54. The therapeutic method of claim 52, wherein the concentration of budesonide in the unit dose is about 0.6 to 0.7 mg/ml.

55. A therapeutic method of treating an inflammatory condition of the upper respiratory tract, the method comprising metering into the nose of a mammal a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, the active ingredient of each unit dose consisting of about 32 .mu.g budesonide formulated as finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0.

56. The therapeutic method of claim 55, wherein the pH of the aqueous medium is between 4.2 and 4.6.

57. The therapeutic method of claim 55, wherein the concentration of budesonide in each unit dose is about 0.6 to 0.7 mg/ml.

58. A unit dose of a therapeutic composition, the active ingredient of which consists of about 32 .mu.g budesonide, wherein the therapeutic composition additionally comprises a mixture consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the mixture at about 0.5 to 2.5% by weight of the therapeutic composition; dextrose; Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition; disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, wherein the budesonide is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium having a pH between 3.5 and 5.0, said therapeutic composition being suitable for nasal administration to a mammal in a single dose.

59. The unit dose of claim 58, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

60. The unit dose of claim 58, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

61. The unit dose of claim 58, wherein the concentration of budesonide in the composition is about 0.6 to 0.7 mg/ml.

62. A container containing budesonide and adapted to deliver the unit dose of claim 7.

63. A container containing budesonide and adapted to deliver the unit dose of claim 8.

64. A container containing budesonide and adapted to deliver the unit dose of claim 9.

65. A container containing budesonide and adapted to deliver the unit dose of claim 26.

66. A container containing budesonide and adapted to deliver the unit dose of claim 27.

67. A container containing budesonide and adapted to deliver the unit dose of claim 44.

68. A container containing budesonide and adapted to deliver the unit dose of claim 45.

69. The method of claim 2, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

70. The method of claim 10, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

71. The method of claim 14, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

72. The method of claim 70, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

73. The method of claim 31, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

74. The method of claim 40, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

75. The method of claim 46, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

76. The method of claim 52, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.

77. The method of claim 55, wherein the inflammatory condition of the upper respiratory tract is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps, chronic sinusitis, and recurrent sinusitis.
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