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Claims for Patent: 6,251,368

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Claims for Patent: 6,251,368

Title: Pharmaceutical aerosol formulation containing a particulate medicament, a propellant and substantially free of a surfactant
Abstract:A pharmaceutical aerosol formulation which comprises particulate medicament selected from the group consisting of salmeterol, salbutamol, fluticasone propionate, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof and a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant, which formulation is substantially free of surfactant is disclosed. Also disclosed is a method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the, pharmaceutical aerosol formulation which may be contained in a canister.
Inventor(s): Akehurst; Rachel Ann (Ware, GB), Taylor; Anthony James (Ware, GB), Wyatt; David Andrew (Ware, GB)
Assignee: Glaxo Group Limited (Greenford, GB)
Application Number:08/877,198
Patent Claims: 1. A pharmaceutical aerosol formulation which comprises particulate medicament selected from the group consisting of salmeterol, salbutamol, fluticasone propionate, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof and 1,1,1,2-tetrafluoroethane as propellant, which formulation is substantially free of surfactant and with the proviso that when said formulation consists essentially of salbutamol and 1,1,1,2-tetrafluoroethane in a weight ratio of 0.05:18, said salbutamol is present in the form of a physiologically acceptable salt.

2. A formulation as claimed in claim 1 wherein the medicament is salmeterol xinafoate.

3. A formulation as claimed in claim 1 wherein the medicament is salbutamol sulphate.

4. A formulation as claimed in claim 1 wherein the medicament is fluticasone propionate.

5. A formulation as claimed in claim 1 wherein the medicament is beclomethasone dipropionate or a physiologically acceptable solvate thereof.

6. A formulation as claimed in any one of claims 1 or 2 to 5 wherein the medicament is present in an amount of 0.005 to 10% w/w based on the total weight of the formulation.

7. A formulation as claimed in any one of claims 1, 2 to 5 or 6 which contains two or more particulate medicaments.

8. A formulation as claimed in claim 7 which contains salbutamol or salmeterol or a physiologically acceptable salt thereof in combination with an anti-inflammatory steroid or an anti-allergic.

9. A formulation as claimed in claim 8 which contains salmeterol or salbutamol or a physiologically acceptable salt thereof in combination with fluticasone propionate or beclomethasone dipropionate or a physiologically acceptable solvate thereof.

10. A formulation as claimed in claim 9 which contains salmeterol xinafoate and fluticasone propionate.

11. A formulation as claimed in claim 9 which contains salbutamol and beclomethasone dipropionate.

12. A formulation as claimed in any one of claims 1, 2 to 5 or 7 to 11 which has a respirable fraction of 20% or more by weight of the medicament.

13. A formulation as claimed in any one of claims 1, 2 to 5 or 8-12 wherein said particulate medicament is surface-modified.
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