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Claims for Patent: 5,603,918

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Claims for Patent: 5,603,918

Title: Aerosol composition of a salt of ipratropium and a salt of albuterol
Abstract:The present invention is concerned with an aerosol formulation which contains an effective amount of a pharmaceutically acceptable salt of ipratropium and an effective amount of a pharmaceutically acceptable salt of albuterol in combination with an effective amount of soya lecithin as a suspending agent and a propellant.
Inventor(s): McNamara; Daniel (Waterbury, CT)
Assignee: Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT)
Application Number:08/489,201
Patent Claims: 1. An aerosol formulation which comprises an effective amount of a micronized pharmaceutically acceptable salt of ipratropium and an effective amount of a micronized pharmaceutically .acceptable salt of albuterol with an effective amount of soya lecithin as a suspending agent and a propellant.

2. An aerosol formulation as defined in claim 1 wherein the propellant comprise a mixture of trichloromonofluoromethane; dichlorodifluoromethane and dichlorotetrafluoroethane.

3. An aerosol formulation as defined in claim 2 which contains from 0.1 to 0.3 wt % of soya lecithin based on the combined weight of the pharmaceutically acceptable salt of ipratropium, the pharmaceutically acceptable salt of albuterol, the weight of the soya lecithin and the weight of the propellant.

4. An aerosol formulation as defined in claim 1 wherein the pharmaceutically acceptable salt of ipratropium is ipratropium bromide.

5. An aerosol formulation as defined in claim 1 wherein the pharmaceutically salt of albuterol is albuterol sulfate.

6. An aerosol formulation as defined in claim 1 which contains from 0.1 to 0.3 wt % of soya lecithin based on the combined weight of the pharmaceutically acceptable salt of ipratropium, the pharmaceutically acceptable salt of albuterol, the weight of the soya lecithin and the weight of the propellant.

7. An aerosol formulation which consists essentially of an effective amount of a micronized ipratropium bromide, an effective amount of micronized albuterol sulfate, an effective amount of soya lecithin as a suspending agent and a propellant which consists essentially of a mixture of trichloromonofluoromethane; dichlorodifluoromethane and dichlorotetrafluoroethane, wherein the effective amount of the soya lecithin is from 0.1 to 0.3 wt % of soya lecithin based on the combined weight of the ipratropium bromide, the albuterol sulfate, the weight of the soya lecithin and the weight of the trichloromonofluoromethane; dichlorodifluoromethane and dichlorotetrafluoroethane.

8. An aerosol formulation as defined in claim 7 wherein the effective amount of soya lecithin is about 0.1 wt %.

9. An aerosol formulation as defined in claim 7 wherein the effective amount of soya lecithin is about 0.2 wt %.

10. A method of formulating a stable aerosol formulation of a micronized pharmaceutically acceptable salt of ipratropium and a micronized pharmaceutically acceptable salt of albuterol, said method comprising combining a micronized pharmaceutically acceptable salt of ipratropium with micronized a pharmaceutically acceptable salt of albuterol, an effective amount of soya lecithin and a propellant.

11. A method of formulating a stable aerosol as defined in claim 10 wherein the pharmaceutically acceptable salt of albuterol is albuterol sulfate.

12. A method of formulating a stable aerosol formulation as defined in claim 10 wherein the pharmaceutically acceptable salt of ipratropium is ipratropium bromide.

13. A method of formulating a stable aerosol as defined in claim 12 wherein the pharmaceutically acceptable salt of albuterol is albuterol sulfate, the effective amount of soya lecithin is from 0.1 to 0.3 wt % based on the combined weight of the ipratropium bromide, a pharmaceutically acceptable salt of albuterol, the weight of the soya lecithin and the weight of the propellant.

14. A method of formulating a stable aerosol as defined in claim 13 wherein the propellant comprises a mixture of a mixture of trichloromonofluoromethane; dichlorodifluoromethane and dichlorotetrafluoroethane.
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