Details for Patent: 6,750,210
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Title: | Formulation containing novel anti-inflammatory androstane derivative |
Abstract: | There is provided a pharmaceutical aerosol formulation comprising (i) a compound of formula (I) ##STR1## or a solvate thereof as medicament, (ii) a liquified hydrofluoroalkane (HFA) gas as propellant; and characterized in that the compound of formula (I) or a solvate thereof is completely dissolved in the formulation. |
Inventor(s): | Biggadike; Keith (Stevanage, GB) |
Assignee: | SmithKline Beecham Corporation (Philadelphia, PA) |
Filing Date: | Feb 04, 2002 |
Application Number: | 10/066,964 |
Claims: | 1. A pharmaceutical aerosol formulation comprising (i) a compound of formula (I) ##STR9## or a solvate thereof as medicament, (ii) a liquefied hydrofluoroalkane (HFA) gas as propellant; and characterised in that the compound of formula (I) or a solvate thereof is completely dissolved in the formulation. 2. A formulation according to claim 1 which contains a hydroxy containing co-solvent liquid as solubilising agent. 3. A formulation according to claim 2 wherein the solubilsing agent is ethanol. 4. A formulation according to claim 1 further comprising a low volatility component. 5. A formulation according to claim 4 wherein the low volatility component is glycerol. 6. A formulation according to claim 1 wherein the propellant gas is 1,1,1,2-tetrafluoroethane. 7. A pharmaceutical aerosol formulation according to claim 1 comprising (i) a compound of formula (I) ##STR10## or a solvate thereof as medicament, (ii) 1,1,1,2-tetrafluoroethane as propellant, (iii) a solubilising agent to assist the solubilisation of the medicament in the propellant and (iv) optionally a low volatility component; characterised in that the compound of formula (I) or a solvate thereof is completely dissolved in the formulation. 8. A formulation according to claim 7 which contains ethanol as solubilising agent and glycerol as low volatility component. 9. A formulation according to claim 1 wherein the solubilising agent is an oligolactic acid or derivative thereof. 10. A formulation according to claim 9 wherein the solubilising agent is a compound of formula (IIA) or a derivative thereof, wherein n is an integer from 3 to 15. 11. A canister comprising a container containing a formulation according to claim 1 and fitted with a metering valve. 12. A canister comprising a container containing a formulation according to claim 7 and fitted with a metering valve. 13. A canister comprising a container containing a formulation according to claim 9 and fitted with a metering valve. 14. A metered dose inhaler comprising a canister according to claim 11 fitted with an actuator adapted for topical administration of the formulation to the lung. 15. A metered dose inhaler comprising a canister according to claim 11 fitted with an actuator adapted for topical administration of the formulation to the nose. 16. A metered dose inhaler comprising a canister according to claim 12 fitted with an actuator adapted for topical administration of the formulation to the lung. 17. A metered dose inhaler comprising a canister according to claim 12 fitted with an actuator adapted for topical administration of the formulation to the nose. 18. A metered dose inhaler comprising a canister according to claim 13 fitted with an actuator adapted for topical administration of the formulation to the lung. 19. A metered dose inhaler comprising a canister according to claim 13 fitted with an actuator adapted for topical administration of the formulation to the nose. |