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Last Updated: April 25, 2024

Claims for Patent: 10,166,247


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Summary for Patent: 10,166,247
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 (Sodertalje, SE)
Application Number:15/427,425
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,166,247
Patent Claims: 1. A stable pharmaceutical composition comprising formoterol, budesonide or an epimer thereof, 1,1,1-2,3,3,3-heptafluoropropane (HFA 227), polyvinyl pyrrolidone (PVP) and polyethylene glycol (PEG).

2. The composition according to claim 1 wherein the PVP is present from about 0.0005 to about 0.05% w/w and the PEG is present from about 0.05 to about 0.35% w/w.

3. The pharmaceutical composition according to claim 1 in which the PVP is PVP K25.

4. The pharmaceutical composition according to claim 1 in which the PVP is present in an amount of 0.001% w/w.

5. The pharmaceutical composition according to claim 1 in which the PEG is PEG 1000.

6. The pharmaceutical composition according to claim 1 in which the PEG is present in an amount of 0.3% w/w.

7. The pharmaceutical composition according to claim 1 in which the formoterol is in the form of its fumarate dihydrate salt.

8. The pharmaceutical composition according to claim 1 in which the formoterol is in the form of its R, R-enantiomer.

9. The pharmaceutical composition according to claim 1 in which the budesonide or an epimer thereof is the 22R-epimer of budesonide.

10. The pharmaceutical composition according to claim 1 effective in the treatment of a respiratory disorder.

11. The pharmaceutical composition according to claim 1 effective in the treatment or asthma, rhinitis or COPD.

12. A method of treating a respiratory disorder in a mammal in need thereof, which comprises administering to the mammal an effective amount of the pharmaceutical composition according to claim 1.

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