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US 2002/0002204 A1Published application
Albuterol formulations
AssigneeSepracor Inc.
InventorsRobert J. Wherry, Stewart H. Muelller
Life of this patent
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Abstract
Albuterol formulations packaged in an oxygen-permeable plastic container have a long shelf life at room temperature. The formulations consist essentially of albuterol or a pharmaceutically acceptable salt thereof, sodium chloride, and water, have a pH of about 4, and contain less than 0.08% by weight of albuterol aldehyde and less than 1 ppm dissolved oxygen.
Claims11
A method of manufacturing a packaged albuterol formulation having a long shelf life comprising:
- blowing nitrogen gas through a hollow cylinder of an oxygen-permeable plastic and molding the hollow cylinder into an oxygen-permeable container, thereby at least partially enclosing a reduced oxygen atmosphere;
- filling the oxygen-permeable container with an aqueous formulation of albuterol, or a pharmaceutically acceptable salt thereof, said aqueous formulation containing less than 0.05% by weight of albuterol aldehyde and less than 1 ppm dissolved oxygen;
- enclosing the oxygen-permeable container in a reduced oxygen atmosphere within an oxygen-impermeable wrapper to produce a package enclosing an atmosphere containing less than about 2% oxygen.
A stable packaged pharmaceutical formulation consisting essentially of:
- albuterol or a pharmaceutically acceptable salt thereof;
- sodium chloride;
- and
- water;
- said formulation having a pH of about 4, containing less than 0.08% by weight of albuterol aldehyde and less than 1 ppm dissolved oxygen, enclosed within an oxygen-permeable plastic container, and remaining at less than 0.08% by weight of albuterol aldehyde after storage at 40° C. for six months.
2 more elements
A unit dosage formulation for administration by inhalation consisting essentially of:
- 0.18-1.4 mg albuterol or a pharmaceutically acceptable salt thereof;
- 27 mg sodium chloride;
- and
- 2-4 mL water;
- said unit dosage formulation having a pH of about 4, containing less than 1 ppm dissolved oxygen and containing less than 0.08% by weight of albuterol aldehyde after storage at 40° C. for six months.
2 more elements
Dependencies are inferred from the claim text.