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Details for Patent: 6,333,023

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Details for Patent: 6,333,023

Title: Aerosol formulation containing particulate formoterol, propellant and polar cosolvent
Abstract:A pharmaceutical aerosol formulation comprising (i) particulate medicament, (ii) 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3,-heptafluoro-n-propane or a mixture thereof as propellant, and (iii) 0.01 to 5% w/w based upon the propellant of a polar cosolvent, the particulate medicament being present in an amount from 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns, and which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament.
Inventor(s): Akehurst; Rachel Ann (Ware, GB), Taylor; Anthony James (Ware, GB), Wyatt; David Andrew (Ware, GB)
Assignee: Glaxo Group Limited (Greenford, GB)
Filing Date:May 01, 2000
Application Number:09/562,098
Claims:1. A pharmaceutical aerosol formulation consisting essentially of (i) a particulate medicament which is formoterol or a salt or solvate thereof, (ii) 1,1,1,2-tetrafluoroethane as propellant, and (iii) 0.05 to 5% w/w based upon propellant of a polar cosolvent which is ethanol, the particulate medicament being present in an amount from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size less than 100 microns, and which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament.

2. A pharmaceutical aerosol formulation consisting of (i) a particulate medicament which is formoterol or a salt or solvate thereof, (ii) 1,1,1,2-tetrafluoroethane as propellant, and (iii) 0.05 to 5% w/w based upon propellant of a polar cosolvent which is ethanol, the particulate medicament being present in an amount from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size less than 100 microns.

3. A formulation as claimed in claim 1 wherein the polar cosolvent is present in an amount of 0.05 to 3% w/w based upon the propellant.

4. A formulation as claimed in claim 1 wherein the polar cosolvent is present in an amount of less than 1% w/w based upon the propellant.

5. A formulation as claimed in claim 1 wherein the polar cosolvent is present in an amount of approximately 0.1% w/w based upon the propellant.

6. A formulation as claimed in claim 1 wherein the particulate medicament is present in an amount from 0.01% to 1% w/w relative to the total weight of the formulation.

7. A formulation as claimed in claim 2 wherein the polar cosolvent is present in an amount of 0.05 to 3% w/w based upon the propellant.

8. A formulation as claimed in claim 2 wherein the polar cosolvent is present in an amount of less than 1% w/w based upon the propellant.

9. A formulation as claimed in claim 2 wherein the polar cosolvent is present in an amount of approximately 0.1% w/w based upon the propellant.

10. A formulation as claimed in claim 2 wherein the particulate medicament is present in an amount from 0.01% to 1% w/w relative to the total weight of the formulation.

11. A pharmaceutical aerosol formulation consisting essentially of (i) particulate medicament which is formoterol or a salt or solvate thereof, (ii) 1,1,1,2-tetrafluoroethane as propellant, and (iii) approximately 0.1% w/w based upon propellant of a polar cosolvent which is ethanol, the particulate medicament being present in an amount from 0.01 to 1% w/w relative to the total weight of the formulation and having a particle size less than 100 microns, and which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament.

12. A pharmaceutical aerosol formulation consisting of (i) particulate medicament which is formoterol or a salt or solvate thereof, (ii) 1,1,1,2-tetrafluoroethane as propellant, and (iii) approximately 0.1% w/w based upon propellant of a polar cosolvent which is ethanol, the particulate medicament being present in an amount from 0.01 to 1% w/w relative to the total weight of the formulation and having a particle size less than 100 microns.

13. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as claimed in claim 1.

14. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as claimed in claim 2.

15. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as claimed in claim 11.

16. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as claimed 12.
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