Suspension aerosol formulations

• US 20040197273A1
• Filed: 04/09/2004
• Published: 10/07/2004
• Est. Priority Date: 12/18/1991
• Status: Abandoned Application

• Current Assignee: 3M Company
• Original Assignee: 3M Company
• Inventors: Schultz, Robert K., Jinks, Philip A., Schultz, David W., Oliver, Martin J., Moris, Robert A.
• Application Number:
  US10/820,817
• Publication Number:
  US 20040197273A1
• Time in Patent Office: Days
• US Class Current: 424/45
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61K 9/124 characterised by the propellant
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system

Abstract

A pharmaceutical suspension aerosol formulation containing HFA-227 as a propellant.

Claims

1. A process for preparing a metered dose inhaler comprising a container closed with a metering valve, said metered dose inhaler containing a pharmaceutical composition suitable for inhalation by a patient, comprising the steps of:

preparing a pharmaceutical suspension formulation consisting essentially of a therapeutically effective amount of one or more particulate drugs sufficient to provide a plurality of therapeutically effective doses of the drug and a propellant selected from the group consisting of HFC 134a, HFC 227, and a mixture thereof; and

providing said particulate drug and said propellant in said metered dose inhaler.

2. The process of claim 1, wherein said metering valve contains a surfactant as a lubricant for the metering valve.

3. The process of claim 2, wherein said metering valve comprises a valve stem and said valve stem contains a surfactant as a lubricant for the valve stem.

4. The process of claim 2, wherein a pharmaceutical suspension is first prepared in bulk outside of said metered dose inhaler and then transferred to said metered dose inhaler equipped with said metering valve using a valve to valve transfer method.

5. The process of claim 3, wherein a pharmaceutical suspension is first prepared in bulk outside of said metered dose inhaler and then transferred to said metered dose inhaler equipped with said metering valve using a valve to valve transfer method.

6. The process of claim 2, wherein said pharmaceutical suspension is provided in a first container and is then transferred into said metered dose inhaler through said metering valve.

7. The process of claim 1, wherein said pharmaceutical suspension is prepared in said metered dose inhaler.

8. The process of claim 1, wherein said pharmaceutical suspension formulation contains a single drug.

9. The process of claim 2, wherein said pharmaceutical suspension formulation contains a single drug.

10. The process of claim 3, wherein said pharmaceutical suspension formulation contains a single drug.

11. A metered dose inhaler prepared by a process according to claim 1.

12. A metered dose inhaler prepared by a process according to claim 2.

13. A metered dose inhaler prepared by a process according to claim 3.

14. A metered dose inhaler prepared by a process according to claim 4.

15. A metered dose inhaler prepared by a process according to claim 5.

16. A metered dose inhaler prepared by a process according to claim 6.

17. A metered dose inhaler prepared by a process according to claim 7.

18. A metered dose inhaler prepared by a process according to claim 8.

19. A metered dose inhaler prepared by a process according to claim 9.

20. A metered dose inhaler prepared by a process according to claim 10.