Suspension aerosol formulations

• US 7,105,152 B1
• Filed: 05/31/1995
• Issued: 09/12/2006
• Est. Priority Date: 12/18/1991
• Status: Expired due to Term

• Current Assignee: Norton Healthcare Incorporated
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Schultz, Robert K., Schultz, David W., Moris, Robert A.
• Primary Examiner(s): Sheikh, Humera N.
• Application Number:
  US08/455,490
• Time in Patent Office: 4,122 Days
• Field of Search: 424 43- 45
• US Class Current: 424/43
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]

Abstract

Pharmaceutical suspension aerosol formulations containing a therapeutically effective amount of a drug and HFC 134a, HFC 227, or a mixture thereof.

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.