Stable aerosol pharmaceutical formulations
First Claim
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1. A pharmaceutical formulation comprising:
- an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a beta-agonist agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a cosolvent selected from the group consisting of polyethylene glycol, propylene glycol, glycerol, and isopropyl myristrate; and
a hydrofluoroalkane propellant.
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Abstract
The present invention provides a stable aerosol pharmaceutical formulation of a beta-agonist, an anticholinergic, or a combination thereof in combination with a cosolvent and optionally a surfactant. The invention also provides a method of making the stable aerosol pharmaceutical formulation and methods of treating bronchoconstriction, asthma and related conditions with the stable aerosol pharmaceutical formulation of the present invention.
99 Citations
32 Claims
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1. A pharmaceutical formulation comprising:
- an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a beta-agonist agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a cosolvent selected from the group consisting of polyethylene glycol, propylene glycol, glycerol, and isopropyl myristrate; and
a hydrofluoroalkane propellant. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 26, 27, 28, 29, 30, 31, 32)
- an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
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15. A pharmaceutical formulation comprising:
- an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a beta-agonist agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a polysorbate; and
a hydrofluoroalkane propellant, wherein there is no cosolvent present in the formulation. - View Dependent Claims (16, 17, 18)
- an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
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19. A method of making a pharmaceutical formulation comprising:
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(a) mixing a hydrofluoroalkane propellant with a cosolvent to form a solution; (b) forming a first homogenized suspension of an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a beta-agonist agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof; and
a hydrofluoroalkane propellant; and(c) adding the first homogenized suspension to the solution to form a second homogeneous suspension. - View Dependent Claims (20, 21, 22)
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23. A method of making a pharmaceutical formulation comprising:
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(a) dissolving a polysorbate in a hydrofluoroalkane propellant to form a solution; (b) forming a first homogenized suspension of an anticholinergic agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof;
a beta-agonist agent or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically acceptable hydrate, pharmaceutically acceptable enantiomer, pharmaceutically acceptable derivative, pharmaceutically acceptable polymorph or pharmaceutically acceptable prodrug thereof; and
a hydrofluoroalkane propellant; and(c) adding the first homogenized suspension to the solution to form a second suspension. - View Dependent Claims (24, 25)
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Specification