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Claims for Patent: 6,532,955

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Claims for Patent: 6,532,955

Title: Metered dose inhaler for albuterol
Abstract:A metered dose inhaler having all or part of its internal surfaces coated with one or more fluorocarbon polymers, optimally in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formation comprising fluticasone propionate or a physiologically acceptable solvate thereof and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents or one or more excipients.
Inventor(s): Ashurst; Ian C. (Ware, GB), Britto; Ignatius Loy (Cary, NC), Herman; Craig Steven (Raleigh, NC), Li-Bovet; Li (Chapel Hill, NC), Riebe; Michael Thomas (Raleigh, NC)
Assignee: SmithKline Beecham Corporation (Philadelphia, PA)
Application Number:09/570,789
Patent Claims: 1. A metered dose inhaler having part or all of its internal surfaces coated with one or more fluorocarbon polymers, optionally in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formulation, comprising a particulate drug and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents or one or more excipients.

2. An inhaler according to claim 1, containing said inhalation drug formulation, wherein said drug formulation comprises albuterol or a physiologically acceptable salt thereof.

3. An inhaler according to claim 2, wherein said drug formulation further comprises a surfactant.

4. An inhaler according to claim 2, wherein said drug formulation further comprises a polar cosolvent.

5. An inhaler according to claim 2 wherein said drug formulation comprises 0.01 to 5% w/w based upon propellant of a polar cosolvent, which formulation is substantially free of surfactant.

6. An inhaler according to claim 2, wherein said drug formulation comprises albuterol or a physiologically acceptable salt thereof in combination with an anti-inflammatory steroid or an antiallergic.

7. An inhaler according to claim 6, wherein said drug formulation comprises albuterol or a physiologically acceptable salt thereof in combination with beclomethasone dipropionate or a physiologically acceptable solvate thereof.

8. An inhaler according to claim 2, wherein said drug formulation consists essentially of albuterol or a physiologically acceptable salt thereof, optionally in combination with one or more other pharmacologically active agents, and a fluorocarbon propellant.

9. An inhaler according to claim 8, wherein said drug formulation consists essentially of albuterol or a physiologically acceptable salt thereof in combination with an anti-inflammatory steroid or an antiallergic.

10. An inhaler according to claim 9, wherein said drug formulation consists essentially of albuterol or a physiologically acceptable salt thereof in combination with beclomethasone dipropionate or a physiologically acceptable solvate thereof.

11. An inhaler according to claim 2, wherein said drug formulation consists of albuterol or a physiologically acceptable salt thereof and a fluorocarbon propellant.

12. An inhaler according to claim 2, wherein said albuterol is in the form of the sulfate salt.

13. An inhaler according to claim 2, wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane, or 1,1,1,2,3,3,3-heptafluoro-n-propane or mixtures thereof.

14. An inhaler according to claim 13, wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane.

15. An inhaler according to claim 1, comprising a can made of metal wherein part or all of the internal metallic surfaces are coated.

16. An inhaler according to claim 15 wherein the metal is aluminium or an alloy thereof.

17. An inhaler according to claim 1, wherein said fluorocarbon polymer is a perfluorocarbon polymer.

18. An inhaler according to claim 17, wherein said fluorocarbon polymer is selected from PTFE, PFA, FEP and mixtures thereof.

19. An inhaler according to claim 1, wherein said fluorocarbon polymer is in combination with a non-fluorocarbon polymer selected from polyamideimide and polyethersulphone.

20. A metered dose inhaler system comprising a metered dose inhaler according to claim 1 fitted into suitable channelling device for oral or nasal inhalation of the drug formulation.

21. A method for the treatment of a respiratory disorder, comprising: administering to a patient by oral or nasal inhalation a drug formulation by using the metered dose inhaler system of claim 20.

22. An inhaler according to claim 1, wherein part or all of the internal surfaces are coated with one or more fluorocarbon polymers in combination with one or more non-fluorocarbon polymers.

23. An inhaler according to claim 1, which contains a drug formulation comprising a particulate drug and fluorocarbon propellant.

24. An inhaler according to claim 23, wherein said propellant comprises 1,1,1,2-tetrafluoroethane.

25. An inhaler according to claim 23, wherein said propellant comprises 1,1,1,2,3,3,3-heptafluoro-n-propane.

26. A metered dose inhaler having part or all of its internal surfaces coated with one or more fluorocarbon polymers, optionally in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formulation, comprising particulate albuterol and a fluorocarbon propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane, and mixtures thereof, optionally in combination with one or more other pharmacologically active agents or one or more excipients.
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