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Claims for Patent: 7,465,756

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Claims for Patent: 7,465,756

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:11/688,436
Patent Claims: 1. A sterile unit dose, comprising: (a) between 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.; (b) packaged in a pharmaceutical packaging material.

2. A sterile unit dose, comprising: (a) between 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.; (b) packaged in a pharmaceutical packaging material.

3. The sterile unit dose as in any one of claims 1 and 2 wherein said buffer is selected from the group consisting of a citric acid/phosphate buffer, acetate buffer, citrate buffer or phosphate buffer.

4. The sterile unit dose of claim 3 wherein said buffer is present at a concentration of between about 1 mM and about 20 mM.

5. The sterile unit dose as in any one of claims 1 and 2 wherein said pharmaceutical packaging material is selected from the group consisting of blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers and syringes

6. The sterile unit dose of claim 5 wherein said pharmaceutical packaging material is a vial over wrapped with a laminate.

7. The sterile unit dose as in any one of claims 1 and 2, wherein said buffer has a concentration of from about 1 mM to about 20 mM.

8. The sterile unit dose as in any one of claims 1 and 2, wherein said composition has a pH of about 5.

9. The sterile unit dose of claim 7, wherein said buffer has a pH of about 5.

10. The sterile unit dose as in any one of claims 1 and 2, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.

11. The sterile unit dose of claim 7, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.

12. A sterile unit dose, comprising: (a) about 0.1 to about 3 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 selected from the group consisting of citric acid/phosphate buffer, acetate buffer, citrate buffer or phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.5 to about 5.5; (b) packaged in a pharmaceutical packaging material.

13. The sterile unit dose of claim 12, wherein said pharmaceutical packaging material is a vial over wrapped with a laminate.

14. The sterile unit dose of claim 12, wherein said buffer has a concentration of from about 1 mM to about 20 mM.

15. The sterile unit dose of claim 12, wherein said composition has a pH of about 5.

16. The sterile unit dose of claim 14, wherein said buffer has a pH of about 5.

17. The sterile unit dose of claim 12, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.

18. The sterile unit dose of claim 14, wherein said (R) formoterol or a salt thereof is (R) formoterol tartate.

19. The sterile unit dose of claim 16, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.
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