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Details for Patent: 8,114,912

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Details for Patent: 8,114,912

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: Mylan Pharmaceuticals, Inc. (Morgantown, WV)
Filing Date:May 24, 2010
Application Number:12/785,965
Claims:1. A kit comprising: (a) 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 .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 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.degree. C. and after 3 years storage at 5.degree. C.; and (b) a nebulizer.

2. A kit comprising: (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 .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 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.degree. C. and greater than about 96% after 3 months storage at 5.degree. C.; and (b) a nebulizer.

3. A kit comprising: (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 .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 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 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) a nebulizer.

4. 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 20 mM.

5. 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 5 mM and about 20 mM.

6. The kit as in any one of claims 1, 2 and 3 wherein said composition has a pH of about 5.

7. The kit as in any of claims 1, 2 or 3, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.

8. The kit as in any one of claims 1, 2 and 3, wherein said (R) formoterol or salt thereof is (R) formoterol fumarate.
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