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Claims for Patent: 8,143,239

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Claims for Patent: 8,143,239

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 (Leicestershire, GB), Marlow; Maria (Leicestershire, GB)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:12/790,196
Patent Claims: 1. A pressurized metered dose inhaler containing a suspension composition comprising formoterol fumarate dihydrate in the form of particles; budesonide in the form of particles; 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, and wherein an actuation of the inhaler delivers 4.5 .mu.g formoterol fumarate dihydrate and 40 to 320 .mu.g budesonide.

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

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

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

5. The inhaler of claim 4, wherein the PVP is PVP K25.

6. The inhaler of claim 5, wherein the PEG is PEG 1000.

7. The inhaler of claim 1, wherein an actuation of the inhaler delivers 40 .mu.g budesonide.

8. The inhaler of claim 1, wherein an actuation of the inhaler delivers 80 .mu.g budesonide.

9. The inhaler of claim 1, wherein an actuation of the inhaler delivers 160 .mu.g budesonide.

10. A pressurized metered dose inhaler containing a suspension composition comprising formoterol fumarate dihydrate in the form of particles; budesonide in the form of particles; 1,1,1,2,3,3,3-heptafluoropropane (HFA227); PVP K25 (polyvinyl pyrrolidone with a nominal K-value of 25); and PEG-1000 (polyethylene glycol with an average molecular weight of 1,000), wherein the budesonide is present at a concentration in the range of 1 mg/ml to 8 mg/ml; the PVP K25 is present at a concentration of 0.001% w/w; and the PEG-1000 is present at a concentration of 0.3% w/w, and wherein an actuation of the inhaler delivers 4.5 .mu.g formoterol fumarate dihydrate and 40 to 320 .mu.g budesonide.

11. The inhaler of claim 10, wherein an actuation of the inhaler delivers 40 .mu.g budesonide.

12. The inhaler of claim 10, wherein an actuation of the inhaler delivers 80 .mu.g budesonide.

13. The inhaler of claim 10, wherein an actuation of the inhaler delivers 160 .mu.g budesonide.

14. The inhaler of claim 10, wherein the budesonide is in the form of its 22R-epimer.

15. The inhaler of claim 10, wherein the formoterol fumarate dihydrate is in the form of its R,R enantiomer.

16. A method of administering an inhalable composition to a patient, the method comprising providing a pressurized metered dose inhaler containing a suspension composition comprising formoterol fumarate dihydrate in the form of particles, budesonide in the form of particles, 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; the PVP K25 is present at a concentration of 0.001% w/w; and the PEG-1000 is present at a concentration of 0.3% w/w, and wherein an actuation of the inhaler delivers 4.5 .mu.g formoterol fumarate dihydrate and 40 to 320 .mu.g budesonide; and causing the patient to inhale the composition from the inhaler.

17. The method of claim 16, wherein an actuation of the inhaler delivers 40 g budesonide.

18. The method of claim 16, wherein an actuation of the inhaler delivers 80 .mu.g budesonide.

19. The method of claim 16, wherein an actuation of the inhaler delivers 160 .mu.g budesonide.

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

21. The method of claim 16, wherein the patient is suffering from chronic obstructive pulmonary disease (COPD).

22. The method of claim 16, wherein the budesonide is in the form of its 22R-epimer.

23. The method of claim 16, wherein the formoterol fumarate dihydrate is in the form of its R,R enantiomer.

24. A method of administering an inhalable composition to a patient, the method comprising providing a pressurized metered dose inhaler containing a suspension composition comprising formoterol fumarate dihydrate in the form of particles; budesonide in the form of particles; HFA227; PVP; and 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, and wherein an actuation of the inhaler delivers 4.5 .mu.g formoterol fumarate dihydrate and 40 to 320 g budesonide; and causing the patient to inhale the composition from the inhaler.

25. The method of claim 24, wherein an actuation of the inhaler delivers 40 .mu.g budesonide.

26. The method of claim 24, wherein an actuation of the inhaler delivers 80 .mu.g budesonide.

27. The method of claim 24, wherein an actuation of the inhaler delivers 160 .mu.g budesonide.

28. The method of claim 24, wherein the patient is suffering from asthma.

29. The method of claim 24, wherein the patient is suffering from chronic obstructive pulmonary disease (COPD).

30. The method of claim 24, wherein the budesonide is in the form of its 22R-epimer.

31. The method of claim 24, wherein the formoterol fumarate dihydrate is in the form of its R,R enantiomer.
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