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Claims for Patent: 7,462,645

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Claims for Patent: 7,462,645

Title:Bronchodilating beta-agonist compositions and methods
Abstract:Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.
Inventor(s): Chaudry; Imtiaz A. (American Canyon, CA), Pham; Stephen (Sacramento, CA), Banerjee; Partha S. (Wynnewood, PA)
Assignee: JPMorgan Chase Bank, N.A. (Chicago, IL)
Application Number:11/688,429
Patent Claims: 1. A method of treating undesired and/or uncontrolled bronchoconstriction comprising the steps of: (a) adding to a nebulizer, from a propellant-free, sterile unit dose in pharmaceutical packaging material about 1 to about 3 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 .mu.g/mL to about 43 .mu.g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer selected from the group consisting of citric acid/phosphate buffer, acetate buffer, citrate buffer and phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of between about 4.5 and about 5.5; and (b) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.

2. A method of treating undesired and/or uncontrolled bronchoconstriction comprising the steps of: (a) adding to a nebulizer from a propellant-free, sterile unit dose in pharmaceutical packaging material about 1 to about 3 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 .mu.g/mL to about 43 .mu.g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer selected from the group consisting of citric acid/phosphate buffer, acetate buffer, citrate buffer and phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of between about 4.5 and about 5.5 and having an estimated shelf life of greater than 90% after 3 months storage at 25.degree. C. and after 3 years storage at 5.degree. C.; and (b) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.

3. A method of treating undesired and/or uncontrolled bronchoconstriction comprising the steps of: (a) adding to a nebulizer from a propellant-free, sterile unit dose in pharmaceutical packaging material about 2 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 .mu.g/mL to about 43 .mu.g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition farther comprises water and a citrate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of about 5 and having an estimated shelf life of greater than about 94% after 3 months storage at 25.degree. C. and greater than about 96% after 3 months storage at 5.degree. C.; and (b) directly administering said composition to a subject in need thereof, without dilution or other modification of said composition prior to administration.

4. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said undesired and/or uncontrolled bronchoconstriction is a symptom or condition of asthma.

5. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said undesired and/or uncontrolled bronchoconstriction is a symptom or condition of chronic obstructive pulmonary disease.

6. The method as in any one of claims 1 and 2 wherein said buffer is present at a concentration of between about 1 mM and about 20 mM.

7. The method as in any one of claims 1, 2 and 3 wherein said Pharmaceutical packaging material is selected from the group consisting of blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers and syringes.

8. The method of claim 7 wherein said pharmaceutical packaging material is a vial over wrapped with a laminate.

9. The method as in any one of claims 1 and 2, wherein about 2.0 mL of the composition is nebulized.
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