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Claims for Patent: 6,641,800

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Claims for Patent: 6,641,800

Title: Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane
Abstract:Pressurized aerosol composition for administration by inhalation comprising a liquefied hydrofluoroalkane, a powdered medicament dispersed therein, and a suspending agent comprising a polymer soluble in the liquefied hydrofluoroalkane which is selected from polymers including recurring amide containing structural units, copolymers of amide containing units and carboxylic acid ester units, polyvinylacetate and acrylic acid/methacrylic acid ester copolymers.
Inventor(s): Mistry; Suresh N (Birstall, GB), Gibson; Mark (Shepshed, GB)
Assignee: Fisons Ltd. (West Malling, GB)
Application Number:09/616,069
Patent Claims: 1. A pressurized suspension aerosol composition comprising a liquefied hydrofluoroalkane, a powdered medicament dispersed therein, wherein the medicament particles in said powdered medicament have a mass median diameter of 0.01 to 10 microns, and a suspending agent comprising a polymer soluble in the liquefied hydrofluoroalkane, said polymer being present in an amount of 0.00001 to 10% w/w, said polymer being different from said powdered medicament and being selected from the group consisting of polymers including recurring 1-ethylene-pyrrolidin-2-one units, copolymers of 1-ethylene-pyrrolidin-2-one units and vinylacetate units, polyvinylacetate and acrylic acid/methacrylic acid ester copolymers, and wherein said aerosol composition is for administration by inhalation.

2. The composition according to claim 1 wherein the polymer includes recurring 1-ethylene-pyrrolidin-2-one units.

3. The composition according to claim 1 wherein the polymer is polyvinylpyrrolidone.

4. The composition according to claim 1 wherein the polymer is a copolymer containing recurring 1-ethylene-pyrrolidin-2-one units.

5. The composition according to claim 1 wherein the polymer is polyvinylpyrrolidone/vinyl acetate copolymer.

6. The composition according to claim 1 wherein the polymer is polyvinylacetate or a copolymer of acrylic acid and methacrylic acid esters.

7. The composition according to claim 1 which contains less than 10% w/w of excipients capable of increasing the solubility of the polymer in the hydrofluoroalkane.

8. The composition according to claim 1 which contains less than 5% w/w of excipients capable of increasing the solubility of the polymer in the hydrofluoroalkane.

9. The composition according to claim 1 which contains less than 10% w/w of ethanol.

10. The composition according to claim 1 which contains less than 5% w/w of ethanol.

11. The composition according to claim 1 which contains an excipient which acts as a valve lubricant.

12. The composition according to claim 1 which contains a flavor modifying excipient.

13. The composition according to claim 1 which contains a flavor modifying excipient and an excipient which acts as a valve lubricant.

14. The composition according to claim 1 wherein the excipient which acts as a valve lubricant comprises polyethylene glycol.

15. The composition according to claim 14 wherein the polyethylene glycol has a mean molecular weight of from 200 to 3000.

16. The composition according to claim 15 wherein the polyethylene glycol has a mean molecular weight of from 400 to 2000.

17. The composition according to claim 1 wherein the excipient which acts as a valve lubricant, is present at a concentration of between 0.01 to 4% w/w.

18. The composition according to claim 17 wherein the excipient which acts as a valve lubricant is present at a concentration of between 0.1 to 2% w/w.

19. The composition according to claim 1 wherein the flavor modifying excipient comprises one or more of peppermint oil, menthol, saccharin or saccharin sodium.

20. The composition according to claim 1 wherein the hydrofluoroalkane is CF.sub.3 CHFCF.sub.3.

21. The composition according to claim 1, wherein the medicament is selected from the group consisting of terbutaline sulphate, beclomethasone dipropionate, salbutamol sulphate, fluticasone propionate, reproterol hydrochloride, fenoterol hydrobromide, sodium cromoglycate, nedocromil sodium, tipredane, pentamidine isethionate, clemastine, acetyl-.beta.-methylcholine bromide and budesonide.

22. The composition according to claim 1 wherein the concentration of medicament is from 0.01 to 15% w/w.

23. The composition according to claim 1 wherein the hydrofluoroalkane is CF.sub.3 CHFCF.sub.3 and the polymer includes recurring 1-ethylene-pyrrolidin-2-one units.

24. The composition according to claim 23 wherein the polymer is polyvinylpyrrolidone.

25. The composition according to claim 24 which contains less than 10% w/w of ethanol.

26. The composition according to claim 24 which contains less than 5% w/w of ethanol.

27. The composition according to claim 26 which contains polyethylene glycol.

28. The composition according to claim 24 which contains polyethylene glycol.

29. The composition according to claim 23 which contains less than 10% w/w of ethanol.

30. The composition according to claim 23 which contains less than 5% w/w of ethanol.

31. The composition according to claim 23 which contains polyethylene glycol.

32. A process for the preparation of a composition according to claim 1, which comprises dispersing the powdered medicament and the suspending agent in the liquefied hydrofluoroalkane.
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