United States Patent:  6,004,537

Assignee:  Baker Norton Pharmaceuticals, Inc. (Miami, FL)

Filed:  December 18, 1998

Provided is a solution aerosol formulation adapted for use in a pressurized aerosol container. The aerosol formulation is formulated from a composition containing Budesonide, Formoterol at least one fluoroalkane propellant, and a cosolvent present in an amount that dissolves or solubilizes the Budesonide and Formoterol in the mixture of cosolvent and propellant.

SUMMARY OF THE INVENTION

An objective of the present invention is to provide a pressurized metered dose inhaler containing a stable solution formulation of Budesonide and Formoterol which does not require the use of refrigeration.

Another objective of the present invention is to provide a stable solution formulation of Budesonide and Formoterol that is suitable for use as an aerosol, which does not require the use of refrigeration.

The above objectives and other objectives are surprisingly achieved by the following. The present invention provides a novel pressurized metered dose inhaler comprising a container equipped with a metering valve and containing a pressurized solution aerosol formulation formulated from a composition comprising:

Budesonide;

Formoterol;

at least one fluoroalkane propellant; and

a cosolvent present in an amount that dissolves or solubilizes the Budesonide and Formoterol in the mixture of cosolvent and propellant.

The present invention also provides a novel solution aerosol formulation formulated from a composition comprising:

Budesonide;

Formoterol;

at least one fluoroalkane propellant; and

a cosolvent present in an amount that dissolves or solubilizes the Budesonide and Formoterol in the mixture of cosolvent and propellant.

Claim 1 of 30 Claims

1. A pressurized metered dose inhaler comprising a container equipped with a metering valve and containing a pressurized solution aerosol formulation formulated from a composition comprising:

about 0.01 to about 1% by weight of Budesonide;

about 0.01 to about 0.5% by weight of Formoterol;

about 60 to about 94% by weight of at least one fluoroalkane propellant; and

a cosolvent present in an amount that dissolves or solubilizes said Budesonide and Formoterol in the mixture of cosolvent and propellant, wherein said cosolvent is at least one selected from the group consisting of alcohols, ethers, hydrocarbons and perfluorocarbons.

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