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Claims for Patent: 7,105,152

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Claims for Patent: 7,105,152

Title:Suspension aerosol formulations
Abstract:Pharmaceutical suspension aerosol formulations containing a therapeutically effective amount of a drug and HFC 134a, HFC 227, or a mixture thereof.
Inventor(s): Schultz; Robert K. (San Diego, CA), Schultz; David W. (St. Paul, MN), Moris; Robert A. (Lino Lakes, MN)
Assignee: 3M Innovative Properties Company (St. Paul, MN)
Application Number:08/455,490
Patent Claims: 1. A pharmaceutical suspension aerosol formulation consisting essentially of: (i) particulate drug; (ii) 1,1,1,2-tetrafluoroethane as propellant; and (iii) ethanol in an amount of 5 to about 15 percent by weight, wherein the formulation is further characterized in that it contains no surfactant.

2. The pharmaceutical suspension aerosol formulation of claim 1, wherein the drug is micronized.

3. An aerosol canister equipped with a metering valve, containing a formulation according to claim 1 in an amount sufficient to provide a plurality of therapeutically effective doses of the drug.

4. The pharmaceutical suspension aerosol formulation of claim 1, wherein the particulate drug is selected from the group consisting of formoterol, salmeterol, beclomethasone dipropionate, cromolyn, pirbuterol, albuterol, and pharmaceutically acceptable salts or solvates thereof.

5. The pharmaceutical suspension aerosol formulation of claim 4, wherein the particulate drug is formoterol or a pharmaceutically acceptable salt or solvate thereof.

6. The pharmaceutical suspension aerosol formulation of claim 5, wherein the particulate drug is formoterol fumarate.

7. The pharmaceutical suspension aerosol formulation of claim 4, wherein the particulate drug is salmeterol or a pharmaceutically acceptable salt or solvate thereof.

8. The pharmaceutical suspension aerosol formulation of claim 4, wherein the particulate drug is albuterol or a pharmaceutically acceptable salt or solvate thereof.

9. The pharmaceutical suspension aerosol formulation of claim 8, wherein the particulate drug is albuterol sulfate.

10. The pharmaceutical suspension aerosol formulation of claim 4, wherein the particulate drug is pirbuterol or a pharmaceutically acceptable salt or solvate thereof.

11. The pharmaceutical suspension aerosol formulation of claim 10, wherein the particulate drug is pirbuterol acetate, and the range of ethanol is from 5 to 12 percent by weight.

12. The pharmaceutical suspension aerosol formulation of claim 4, wherein the particulate drug is beclomethasone dipropionate a pharmaceutically acceptable solvate thereof.

13. The pharmaceutical suspension aerosol formulation of claim 4, wherein the particulate drug is cromolyn or a pharmaceutically acceptable salt or solvate thereof.

14. The pharmaceutical suspension aerosol formulation of claim 13, wherein the particulate drug is disodium cromoglycate.
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