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Last Updated: November 2, 2024

Claims for Patent: 6,546,928


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Summary for Patent: 6,546,928
Title: Metered dose inhaler for fluticasone propionate
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 albuterol or a physiologically acceptable salt 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:09/570,725
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, wherein said MDI comprises a strengthened can having side walls and a base and said base has a thickness of greater than 0.46 mm.

2. An inhaler according to claim 1, containing said inhalation drug formulation, wherein said drug formulation comprises fluticasone propionate 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 further 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 fluticasone propionate or a physiologically acceptable solvate thereof in combination with a bronchodilator or an antiallergic.

7. An inhaler according to claim 6, wherein said drug formulation comprises fluticasone propionate in combination with salmeterol xinafoate.

8. An inhaler according to claim 2, wherein said drug formulation consists essentially of fluticasone propionate or a physiologically acceptable solvate 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 fluticasone propionate or a physiologically acceptable solvate thereof in combination with a bronchodilator or an antiallergic.

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

11. An inhaler according to claim 10, wherein said drug formulation consists essentially of fluticasone propionate in combination with salmeterol xinafoate.

12. An inhaler according to claim 2, wherein said drug formulation consists of fluticasone propionate or a physiologically acceptable solvate thereof and a fluorocarbon propellant.

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 aluminum 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. An inhaler according to claim 1 comprising a substantially ellipsoidal base.

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 a blend comprising polytetrafluoroethylene and polyethersulfone, said metered dose inhaler containing therein an inhalation drug formulation comprising particulate drug and a fluorocarbon propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and mixtures thereof, wherein said MDI comprises a strengthened can having side walls and a base and said base has a thickness of greater than 0.46 mm.

27. A metered dose inhaler having part or all of its internal surfaces coated with a blend comprising polytetrafluoroethylene and polyethersulfone, said metered dose inhaler containing therein an inhalation drug formulation comprising particulate drug and a fluorocarbon propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and mixtures thereof, wherein said MDI comprises a strengthened can having side walls and a base and said base has a thickness of greater than 0.46 mm.

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