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Claims for Patent: 8,575,137

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Claims for Patent: 8,575,137

Title:Composition for inhalation
Abstract: The invention relates to a formulation comprising formoterol and budesonide for use in the treatment of respiratory diseases. The composition further contains HFA 227, PVP and PEG, preferably PVP K25 and PEG 1000.
Inventor(s): Govind; Nayna (Loughborough, GB), Marlow; Maria (Loughborough, GB)
Assignee: AstraZeneca AB (Macclesfield, GB)
Application Number:13/411,939
Patent Claims: 1. A pharmaceutical suspension composition comprising formoterol fumarate dihydrate; budesonide; 1,1,1,2,3,3,3-heptafluoropropane (HFA227); polyvinyl pyrrolidone (PVP); and polyethylene glycol (PEG), wherein the budesonide is present in the composition at a concentration in the range of 1 mg/ml to 8 mg/ml, the PVP is present at a concentration in the range of 0.001% to 0.01% w/w, and the PEG is present at a concentration in the range of 0.05 to 0.5% w/w.

2. The pharmaceutical suspension composition of claim 1, wherein the PEG is PEG 1000 (PEG with an average molecular weight of 1,000).

3. The pharmaceutical suspension composition of claim 1, wherein the PVP is PVP K25 (PVP with a nominal K-value of 25).

4. The pharmaceutical suspension composition of claim 1, wherein the PVP is present in the composition at a concentration of 0.001% w/w.

5. The pharmaceutical suspension composition of claim 4, wherein the PVP is PVP K25.

6. The pharmaceutical suspension composition of claim 5, wherein the PEG is PEG 1000.

7. The pharmaceutical suspension composition of claim 1, wherein the budesonide is in the form of its 22R-epimer.

8. The pharmaceutical suspension composition of claim 1, wherein the formoterol fumarate dihydrate is in the form of its R,R enantiomer.

9. A pharmaceutical suspension composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000, wherein the budesonide is present at a concentration in the range of 1 mg/ml to 8 mg/ml and the PVP K25 is present at a concentration of 0.001% w/w.

10. The pharmaceutical suspension composition of claim 9, wherein the PEG-1000 is present at a concentration of 0.3% w/w.

11. The pharmaceutical suspension composition of claim 9, wherein the budesonide is in the form of its 22R-epimer.

12. The pharmaceutical suspension composition of claim 9, wherein the formoterol fumarate dihydrate is in the form of its R,R enantiomer.

13. A method of treating a respiratory disorder, the method comprising administering the pharmaceutical suspension composition of claim 1 to a patient identified as in need of treatment with the composition.

14. The method of claim 13, wherein the patient is suffering from asthma.

15. The method of claim 13, wherein the patient is suffering from chronic obstructive pulmonary disease (COPD).

16. A method of treating a respiratory disorder, the method comprising administering the pharmaceutical suspension composition of claim 9 to a patient identified as in need of treatment with the composition.

17. The method of claim 16, wherein the patient is suffering from asthma.

18. The method of claim 16, wherein the patient is suffering from COPD.

19. A method of treating a respiratory disorder, the method comprising administering the pharmaceutical suspension composition of claim 10 to a patient identified as in need of treatment with the composition.

20. The method of claim 19, wherein the patient is suffering from asthma.

21. The method of claim 19, wherein the patient is suffering from COPD.

22. A pressurized metered dose inhaler containing the pharmaceutical suspension composition of claim 1.

23. The inhaler of claim 22, wherein the PEG is PEG 1000.

24. The inhaler of claim 22, wherein the PVP is PVP K25.

25. The inhaler of claim 22, wherein the PVP is present in the composition at a concentration of 0.001% w/w.

26. The inhaler of claim 25, wherein the PVP is PVP K25.

27. The inhaler of claim 26, wherein the PEG is PEG 1000.

28. A pressurized metered dose inhaler containing the pharmaceutical suspension composition of claim 9.

29. A pressurized metered dose inhaler containing the pharmaceutical suspension composition of claim 10.

30. A method of treating a respiratory disorder, the method comprising providing the inhaler of claim 22 to a patient in identified need thereof; and causing the patient to inhale the composition from the inhaler.

31. The method of claim 30, wherein the patient is suffering from asthma.

32. The method of claim 30, wherein the patient is suffering from COPD.

33. A method of treating a respiratory disorder, the method comprising providing the inhaler of claim 22; and instructing a patient in need thereof to inhale the composition from the inhaler.

34. The method of claim 33, wherein the patient is suffering from asthma.

35. The method of claim 33, wherein the patient is suffering from COPD.

36. A method of treating a respiratory disorder, the method comprising providing the inhaler of claim 26 to a patient in identified need thereof; and causing the patient to inhale the composition from the inhaler.

37. The method of claim 36, wherein the patient is suffering from asthma.

38. The method of claim 36, wherein the patient is suffering from COPD.

39. A method of treating a respiratory disorder, the method comprising providing the inhaler of claim 26; and instructing a patient in need thereof to inhale the composition from the inhaler.

40. The method of claim 39, wherein the patient is suffering from asthma.

41. The method of claim 39, wherein the patient is suffering from COPD.

42. A method of treating a respiratory disorder, the method comprising providing the inhaler of claim 28 to a patient in identified need thereof; and causing the patient to inhale the composition from the inhaler.

43. The method of claim 42, wherein the patient is suffering from asthma.

44. The method of claim 42, wherein the patient is suffering from COPD.

45. A method treating a respiratory disorder, the method comprising providing the inhaler of claim 28; and instructing a patient in need thereof to inhale the composition from the inhaler.

46. The method of claim 45, wherein the patient is suffering from asthma.

47. The method of claim 45, wherein the patient is suffering from COPD.

48. A method of treating a respiratory disorder, the method comprising providing the inhaler of claim 29 to a patient in identified need thereof; and causing the patient to inhale the composition from the inhaler.

49. The method of claim 48, wherein the patient is suffering from asthma.

50. The method of claim 48, wherein the patient is suffering from COPD.

51. A method treating a respiratory disorder, the method comprising providing the inhaler of claim 29; and instructing a patient in need thereof to inhale the composition from the inhaler.

52. The method of claim 51, wherein the patient is suffering from asthma.

53. The method of claim 51, wherein the patient is suffering from COPD.
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