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Claims for Patent: 6,123,924

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Claims for Patent: 6,123,924

Title: Pressurized aerosol inhalation compositions
Abstract:Pressurized aerosol inhalation composition consisting essentially of a liquefied hydrofluoroalkane, a powdered medicament dispersible to form a suspension in the liquefied hydrofluoroalkane, and polyvinylpyrrolidone present in a concentration of 0.00001 to 10% w/w.
Inventor(s): Mistry; Suresh N (Birstall, GB), Gibson; Mark (Shepshed, GB)
Assignee: Fisons plc (Suffolk, GB)
Application Number:08/478,338
Patent Claims: 1. A pressurized aerosol inhalation composition consisting essentially of:

a liquefied hydrofluoroalkane;

a powdered medicament dispersible to form a suspension in the liquefied hydrofluoroalkane; and

polyvinylpyrrolidone present in a concentration of 0.00001 to 10% w/w.

2. A composition according to claim 1, wherein the medicament is selected from the group consisting of one or more of terbutaline sulphate, beclomethasone dipropionate, salbutamol sulphate, fluticasone pripionate, reproterol hydrochloride, fenoterol hydrobromide, sodium cromoglycate, nedocromil sodium, tipredane, pentamidine isoethionate, clemastine, acetyl-.beta.-methylcholine bromide and budesonide.

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

4. A composition according to claim 1, wherein the powdered medicament has a mass median diameter of 0.01 to 10 .mu.m.

5. A composition according to claim 1, wherein the powdered medicament has a mass median diameter of 0.001 to 4 .mu.m.

6. A composition according to claim 1, wherein the hydrofluoroalkane is CF.sub.3 CHFCF.sub.3.

7. A composition according to claim 1, wherein the concentration of medicament is from 0.01 to 15% w/w.

8. A composition according to claim 1, which contains an excipient which acts as a valve lubricant.

9. A composition according to claim 1, which contains a flavor modifying excipient.

10. A composition according to claim 1, which contains an excipient which acts as a valve lubricant and a flavor modifying excipient.

11. A composition according to claim 8, wherein the excipient comprises polyethylene glycol.

12. A composition according to claim 11, wherein the polyethylene glycol has a mean molecular weight of from 200 to 3000.

13. A composition according to claim 12, wherein the polyethylene glycol has a mean molecular weight of from 40 to 2000.

14. A composition according to claim 11, wherein the excipient is present at a concentration of between 0.01 to 4% w/w.

15. A composition according to claim 11, wherein the excipient is present at a concentration of between 0.1 to 2% w/w.

16. A composition according to claim 9, wherein the flavor modifying excipient is selected from the group consisting of peppermint oil, menthol, saccharin or saccharin sodium.
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