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Claims for Patent: 7,759,328

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Claims for Patent: 7,759,328

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:10/502,685
Patent Claims: 1. A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, 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 formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml, 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.

2. A pharmaceutical composition according to claim 1, in which the formoterol fumarate dihydrate is the R, R-enantiomer.

3. A pharmaceutical composition according to claim 1, in which the budesonide is the 22R-epimer.

4. A method of treating symptoms of a respiratory disorder, comprising administering to a patient the pharmaceutical composition according to claim 1, wherein the respiratory disorder is asthma, rhinitis, or chronic obstructive pulmonary disease (COPD).

5. The method of claim 4, wherein the respiratory disorder is asthma.

6. The method of claim 4, wherein the respiratory disorder is rhinitis.

7. The method of claim 4, wherein the respiratory disorder is COPD.

8. The method of claim 4, wherein the concentration of budesonide is 1 mg/ml.

9. The method of claim 4, wherein the concentration of budesonide is 2 mg/ml.

10. The method of claim 4, wherein the concentration of budesonide is 4 mg/ml.

11. The method of claim 4, wherein the concentration of budesonide is 8 mg/ml.

12. A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000, wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml, the budesonide is present at a concentration of 1 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.

13. A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000, wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml, the budesonide is present at a concentration of 2 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.

14. A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000, wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml, the budesonide is present at a concentration of 4 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.

15. A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000, wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml, the budesonide is present at a concentration of 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.
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