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Claims for Patent: 6,068,832

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Claims for Patent: 6,068,832

Title: Chlorofluorocarbon-free mometasone furoate aerosol formulations
Abstract:The invention relates to suspension aerosol formulations which exhibit stable particle sizes, containing mometasone furoate, about 1 to about 10 weight percent ethanol and 1,1,1,2,3,3,3-Heptafluoropropane as the propellant. A surfactant, such as oleic acid, can also be included. These formulations are suitable for use in metered dose inhalers.
Inventor(s): Berry; Julianne (Westfield, NJ), Sequeira; Joel A. (Edison, NJ), Chaudry; Imtiaz A. (North Caldwell, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:08/920,611
Patent Claims: 1. An aerosol suspension formulation comprising 1,1,1,2,3,3,3-Heptafluoropropane, about 1 to about 10 weight percent ethanol and micronized mometasone furoate in concentrations at least about 1 percent of the ethanol concentration, the formulation optionally also containing a surfactant.

2. The aerosol suspension formulation of claim 1, comprising about 1 to about 5 weight percent ethanol.

3. The aerosol suspension formulation of claim 1, comprising about 2 to about 5 weight percent ethanol.

4. The aerosol suspension formulation of claim 1, which contains a surfactant.

5. The aerosol suspension formulation of claim 4, wherein the surfactant comprises oleic acid.

6. The aerosol suspension formulation of claim 1, which is contained in a metered dose container.

7. The aerosol suspension formulation of claim 1, which is contained in apparatus delivering a measured amount of about 10 to about 500 micrograms of mometasone furoate from a single actuating operation.

8. A method for treating allergic reactions in the respiratory tract, comprising administering by inhalation an aerosol suspension formulation comprising 1,1,1,2,3,3,3-Heptafluoropropane, about 1 to about 10 weight percent ethanol and micronized mometasone furoate in concentrations at least about 1 percent of the ethanol concentration, the formulation optionally also containing a surfactant.

9. The method of claim 8, wherein the suspension comprises about 1 to about

5 weight percent ethanol.

10. The method of claim 8, wherein the suspension comprises about 2 to about 5 weight percent ethanol.

11. The method of claim 8, wherein the suspension contains a surfactant.

12. The method of claim 11, wherein the surfactant comprises oleic acid.

13. The method of claim 8, wherein the suspension is contained in a metered dose container.

14. The method of claim 8, wherein the suspension is contained in apparatus delivering a measured amount of about 10 to about 500 micrograms of mometasone furoate from a single actuating operation.

15. A metered dose inhaler which contains an aerosol suspension formulation comprising 1,1,1,2,3,3,3-Heptafluoropropane, about 1 to about 10 weight percent ethanol and micronized mometasone furoate in concentrations at least about 1 percent of the ethanol concentration, the formulation optionally also containing a surfactant.

16. The metered dose inhaler of claim 15, wherein about 10 to about 500 micrograms of mometasone furoate are delivered from a single actuating operation.

17. The metered dose inhaler of claim 15, which is adapted for nasal delivery of mometasone furoate.

18. The metered dose inhaler of claim 15, which is adapted for lower airway delivery of mometasone furoate.
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