Stabilized albuterol compositions and method of preparation thereof
OwnerRamana Malladi, Partha S. Banerjee +1inventors
InventorsRamana Malladi, Partha S. Banerjee, Satyajit V. Erram
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Abstract
Stabilized albuterol compositions are provided. The compositions are aqueous inhalation compositions containing albuterol; a buffer, such as citric acid; and a metal chelator, such as EDTA.
Claims45
A pharmaceutical composition, comprising:
- (i) albuterol, or a pharmaceutically acceptable derivative thereof;
- (ii) a buffer;
- and
- (iii) a metal chelator.
A pharmaceutical composition, comprising albuterol, or a pharmaceutically acceptable derivative thereof, wherein the composition is an aqueous composition that is stable for at least 6 months at 40° C. or 18 months at 25° C.
A pharmaceutical composition, comprising albuterol, or a pharmaceutically acceptable derivative thereof, wherein the composition is not sparged with nitrogen and is stable for at least 6 months at 40° C. or 18 months at 25° C. after storage under an ambient atmosphere.
A method of stabilizing an albuterol inhalation pharmaceutical composition, comprising adding a buffer and a metal chelator to the composition.
A method of reducing albuterol aldehyde in an albuterol inhalation pharmaceutical composition, comprising adding a buffer and a metal chelator to the composition.
A combination selected from (i), (ii) or (iii) as follows:
- (i) a combination, comprising (a) a composition comprising albuterol, or a pharmaceutically acceptable derivative thereof, and a buffer, and (b) a metal chelator;
- (ii) a combination, comprising (a) a composition comprising albuterol, or a pharmaceutically acceptable derivative thereof, and a metal chelator;
- and (b) a buffer;
- or
- (iii) a combination, comprising (a) a composition comprising a metal chelator and a buffer, and (b) albuterol, or a pharmaceutically acceptable derivative thereof.
Dependencies are inferred from the claim text.