Claims for Patent: 7,541,385

Summary for Patent: 7,541,385

Title:	Bronchodilating β-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):	Imtiaz A. Chaudry, Stephen Pham, Partha S. Banerjee
Assignee:	Mylan Specialty LP
Application Number:	US11/688,463
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 package about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than 90% after 3 months storage at 25° C. and after 3 years storage at 5° C. (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 package about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than about 94% after 3 months storage at 25° C. and greater than about 96% after 3 months storage at 5° 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 from a propellant-free, sterile unit dose package to a nebulizer about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further 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 4.5 to about 5.5; 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 of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said buffer is present at a concentration of between about 1 mM and about 50 mM. 7. The method of treating undesired and/or uncontrolled bronchoconstriction 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. 8. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said composition has a pH of about 5. 9. The method of treating undesired and/or uncontrolled bronchoconstriction of claim 8 wherein said buffer has a pH of about 5. 10. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1 and 2, wherein about 2.0 mL of the composition is nebulized. 11. The method of treating undesired and/or uncontrolled bronchoconstriction as in any of claims 1, 2 or 3, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.