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Claims for Patent: 6,596,260

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Claims for Patent: 6,596,260

Title: Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosol
Abstract:The invention relates to an aerosol container for pharmaceutically active aerosols that are to be administered in predetermined amounts and that are supplied in the container in the form of a suspension, the suspension also comprising, in addition to a pharmaceutically active substance, at least a propellant gas. The aerosol container has a metering valve that comprises a metering chamber and a valve stem. In a first position of the valve stem, the metering chamber is in communication with the interior of the container and has been filled with a predetermined amount of the aerosol. In a second position of the valve stem, the amount of aerosol disposed in the metering chamber is released. The propellant gas is an alternative propellant gas that is free of fluorochlorohydrocarbons, preferably a propellant gas that comprises only fluorohydrocarbons, and the inner wall of the container is coated with a plastics coating.
Inventor(s): Brugger; Fran.cedilla.ois (Waltenheim, FR), Stampf; Angelika (Rixheim, FR)
Assignee: Novartis Corporation (New York, NY)
Application Number:08/288,415
Patent Claims: 1. An aerosol container system for metering and administering pharmaceutically active aerosols supplied in the form of a suspension, the suspension including a pharmaceutically active agent and a propellant gas free of fluorochlorohydrocarbons, said aerosol container system comprising: a container for storing the suspension comprising a container wall, the inner portion of said container wall which defines the interior of the container being coated with a plastics coating which inhibits the pharmaceutically active agent in the suspension from depositing thereon, and a metering valve system for dosing and releasing the suspension comprising a metering chamber and a valve stem, said valve stem capable of being displaced from a first position to a second position, wherein in the first position the valve stem affords communication between the interior of the container and the metering chamber while simultaneously blocking communication between the metering chamber and the outside of the aerosol container system such that the metering chamber can be filled with a dose of the suspension from the container, and wherein in the second position the valve stem blocks communication between the interior of the container and the metering chamber while simultaneously affording communication between the metering chamber and the outside of the aerosol container system such that the dose of suspension in the metering chamber can be released from the aerosol container system.

2. An aerosol container system according to claim 1, wherein the plastics coating is polytetrafluoroethylen or perfluoroethylenepropylene.

3. An aerosol container system according to claim 1, wherein the thickness of the container wall is in the range from approximately 0.1 mm to approximately 2 mm, and the thickness of the plastics coating is in the range from approximately 1 mm to approximately 1 mm.

4. An aerosol container system according to claim 1, wherein the volume of the interior of the container is in the range from approximately 1 ml to approximately 100 ml and the volume of the metering chamber is from approximately 5 .mu.l to approximately 400 .mu.l.

5. Method for the storage and administration of a pharmaceutically active aerosol in the form of a suspension, the suspension including a pharmaceutically active agent and a propellant gas that is free of fluorochlorohydrocarbons, wherein a container system according to claim 1 is used.

6. Method according to claim 5, wherein the pharmaceutically active agent in the suspension is an anti-asthmatically active agent.

7. Method according to claim 6, wherein the anti-asthmatically active agent is selected from the group consisting of formoterol, formoterol fumarate, and corticosteroids.

8. Method according to claim 6, wherein the anti-asthmatically active agent is (1R,2S)-(3E,5Z)-7-[1-(3-trifluoromethylphenyl)-1-hydroxy-10-(4-acetyl-3-hy droxy-2-propylphenoxy)-3,5-decadien-2-ylthio]-4-oxo-4H-1benzopyrane-2-carbo xylic acid or the sodium salt thereof.

9. An aerosol container system according to claim 1, wherein the propellant gas consists essentially of a fluorohydrocarbons.

10. An aerosol container system according to claim 1, wherein the suspension further includes cosolvents and/or surfactants.

11. An aerosol container system according to claim 3, wherein the thickness of the container wall is approximately 0.4 mm and the thickness of the plastics coating is approximately 10 nm.

12. Method according to claim 5, wherein the propellant gas consists essentially of fluorohydrocarbons.

13. Method according to claim 5, wherein the suspension further includes cosolvents and/or surfactants.

14. Method according to claim 7, wherein the anti-asthmatically active agent includes the corticosteroid 9.alpha.-chloro-6.alpha.-fluoro-11.beta., 17.alpha.-dihydroxy-16.alpha.-methyl-3-oxo-androsta-1,4-diene-17.beta.-met hoxycarbonyl-17-propionate.
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