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Details for Patent: 7,498,020

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Details for Patent: 7,498,020

Title:Medicaments
Abstract: This invention relates to aerosol formulations of use for the administration of medicaments by inhalation, in particular a pharmaceutical aerosol formulation which comprises particulate salbutamol and physiologically acceptable salts and solvates thereof and a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant, which formulation is substantially free of surfactant. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as defined is also described.
Inventor(s): Akehurst; Rachel Ann (Hertsfordshire, GB), Taylor; Anthony James (Hertsfordshire, GB), Wyatt; David Andrew (Hertsfordshire, GB)
Assignee: Glaxo Group Limited (Middlesex, GB)
Filing Date:Nov 23, 2004
Application Number:10/994,318
Claims:1. A process for preparing a filled pharmaceutical aerosol canister which comprises: (a) preparing a pharmaceutical aerosol formulation for use for the administration of medicaments by inhalation wherein the formulation comprises particulate fluticasone propionate as medicament and 1,1,1,2-tetrafluoroethane as propellant, which formulation is free of surfactant and chlorofluorcarbons; and (b) filling the formulation into a canister.

2. A process according to claim 1 wherein the formulation of step (a) is substantially free of alcohols.

3. A process according to claim 1 wherein the formulation of step (a) consists essentially of particulate fluticasone propionate as medicament and 1,1,1,2-tetrafluoroethane as propellant.

4. A process according to claim 1 wherein the formulation of step (a) consists of particulate fluticasone propionate as medicament and 1,1,1,2-tetrafluoroethane as propellant.

5. A process according to claim 1 wherein the formulation of step (a) contains particulate salmeterol or a physiologically acceptable salt thereof in combination with particulate fluticasone propionate as medicament.

6. A process according to claim 5 wherein the formulation of step (a) contains salmeterol xinafoate in combination with fluticasone propionate as medicament.

7. A process according to claim 1 wherein the formulation of step (a) consists essentially of particulate salmeterol or a physiologically acceptable salt thereof in combination with particulate fluticasone propionate as medicament and 1,1,1,2-tetrafluoroethane as propellant.

8. A process according to claim 1 wherein the formulation of step (a) consists of particulate salmeterol or a physiologically acceptable salt thereof in combination with particulate fluticasone propionate as medicament and 1,1,1,2-tetrafluoroethane as propellant.

9. A process according to claim 7 wherein salmeterol is present as its xinafoate salt.

10. A process according to claim 8 wherein salmeterol is present as its xinafoate salt.

11. A process according to claim 1 wherein in the formulation of step (a) the medicament is present in an amount of 0.005-5% w/w relative to the total weight of the formulation.

12. A process according to claim 11 wherein in the formulation of step (a) the medicament is present in an amount of 0.01-1% w/w relative to the total weight of the formulation.

13. A process according to claim 1 wherein in step (a) the formulation is prepared by dispersing the medicament in the propellant.

14. A process according to claim 1 wherein the canister is an aluminium can which is closed with a metering valve.

15. A process according to claim 14 wherein in step (b) an aliquot of the formulation is filled through the metering valve into the canister.

16. A process according to claim 1 which comprises: (a) adding particulate medicament to a charge vessel and pressure filling the liquefied propellant through the charge vessel into a manufacturing vessel to form a drug suspension; (b) mixing the drug suspension before recirculation to a filling machine; and (c) filling an aliquot of the drug suspension through the metering valve into a canister, said canister being formed of an aluminium can to which a metering valve has been crimped.
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