Claims for Patent: 7,566,445

Summary for Patent: 7,566,445

Title:	Medicinal aerosols and methods of delivery thereof
Abstract:	This invention provides a medicinal aerosol formulation comprising a particulate medicament, a fluorocarbon propellant and 6% to 25% w/w of the total formulation of a polar co-solvent, wherein the aerosol formulation is free of surfactant. This invention also provides a medicinal aerosol formulation, including one or more particulate medicaments, one or more fluorocarbon or hydrocarbon or aliphatic gas propellants and 6% to 25% w/w of a polar co-solvent. In addition, this invention provides a canister suitable for delivering a pharmaceutical aerosol formulation, which comprises a container capable of withstanding the vapour pressure of the propellant used, which container is closed with a metering valve and contains a pharmaceutical aerosol formulation which comprises particulate medicament, a propellant, and 6% to 25% of a polar co-solvent, which is substantially free of surfactant, wherein the propellant comprises a fluorocarbon.
Inventor(s):	Millar; Fiona Catherine (Waterford, IE)
Assignee:	Norton Healthcare Limited (GB)
Application Number:	08/999,752
Patent Claims:	1. A product suitable for delivering a pharmaceutical aerosol formulation comprising, (a) an aerosol canister comprising a container closed with a metering valve, said container comprising a pharmaceutical suspension aerosol formulation substantially free of surfactant, and which consists of salbutamol sulphate, ethanol in an amount of 10% w/w to 15% w/w, and 1,1,1,2-tetrafluoroethane, wherein salbutamol sulphate is substantially completely insoluble in the 1,1,1,2-tetrafluoroethane, and (b) an actuator with a spray orifice aperture of from 100 to 300 microns. 2. A product suitable for delivering a pharmaceutical aerosol formulation comprising, (a) an aerosol canister comprising a container closed with a metering valve, said container comprising a pharmaceutical suspension aerosol formulation substantially free of surfactant, and which consists essentially of salbutamol sulphate, ethanol in an amount of 10% w/w to 15% w/w, and 1,1,1,2-tetrafluoroethane, wherein the salbutamol sulphate is substantially completely insoluble in the 1,1,1,2-tetrafluoroethane, and (b) an actuator with a spray orifice aperture of from 100 to 300 microns. 3. The product of claim 1, wherein the aerosol formulation contains ethanol in the amount of 11.4% w/w. 4. The product of claim 1, wherein the aerosol formulation contains salbutamol sulfate in the amount of 0.4% w/w. 5. The product of claim 1, wherein the aerosol formulation contains 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 6. The product of claim 1, wherein the aerosol formulation contains salbutamol sulphate in the amount of 0.4% w/w, ethanol in the amount of 11.4% w/w, and 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 7. The product of claim 2, wherein the aerosol formulation contains ethanol in the amount of 11.4% w/w. 8. The product of claim 2, wherein the aerosol formulation contains salbutamol sulfate in the amount of 0.4% w/w. 9. The product of claim 2, wherein the aerosol formulation contains 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 10. The product of claim 2, wherein the aerosol formulation contains salbutamol sulphate in the amount of 0.4% w/w, ethanol in the amount of 11.4% w/w, and 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 11. A product suitable for delivering a pharmaceutical aerosol formulation comprising, (a) an aerosol canister comprising a container closed with a metering valve, said container comprising a pharmaceutical suspension aerosol formulation substantially free of surfactant, and which consists of salbutamol sulphate, ethanol in an amount of 10% w/w to 15% w/w, and 1,1,1,2-tetrafluoroethane, wherein salbutamol sulphate is substantially completely insoluble in the 1,1,1,2-tetrafluoroethane, and (b) an actuator with a spray orifice aperture of from 150 to 250 microns. 12. The product of claim 11, wherein the aerosol formulation contains ethanol in the amount of 11.4% w/w. 13. The product of claim 11, wherein the aerosol formulation contains salbutamol sulfate in the amount of 0.4% w/w. 14. The product of claim 11, wherein the aerosol formulation contains 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 15. The product of claim 11, wherein the aerosol formulation contains salbutamol sulphate in the amount of 0.4% w/w, ethanol in the amount of 11.4% w/w, and 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 16. A product suitable for delivering a pharmaceutical aerosol formulation comprising, (a) an aerosol canister comprising a container closed with a metering valve, said container comprising a pharmaceutical suspension aerosol formulation substantially free of surfactant, and which consists essentially of salbutamol sulphate, ethanol in an amount of 10% w/w to 15% w/w, and 1,1,1,2-tetrafluoroethane, wherein the salbutamol sulphate is substantially completely insoluble in the 1,1,1,2-tetrafluoroethane, and (b) an actuator with a spray orifice aperture of from 150 to 250 microns. 17. The product of claim 16, wherein the aerosol formulation contains ethanol in the amount of 11.4% w/w. 18. The product of claim 16, wherein the aerosol formulation contains salbutamol sulfate in the amount of 0.4% w/w. 19. The product of claim 16, wherein the aerosol formulation contains 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w. 20. The product of claim 16, wherein the aerosol formulation contains salbutamol sulphate in the amount of 0.4% w/w, ethanol in the amount of 11.4% w/w, and 1,1,1,2-tetrafluoroethane in the amount of 88.2% w/w.