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Claims for Patent: 7,348,362

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Claims for Patent: 7,348,362

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): Banerjee; Partha S. (Wynnewood, PA), Chaudry; Imtiaz A. (Napa, CA), Pham; Stephen (Sacramento, CA)
Assignee: Dey, L.P. (Napa, CA)
Application Number:10/887,785
Patent Claims: 1. A sterile unit dose, comprising: (a) about 0.1 mL to about 3.0 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 .mu.g/mL to about 34 .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 20 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.; (b) packaged in pharmaceutical packaging material.

2. A sterile unit dose, comprising: (a) about 0.1 mL to about 3.0 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 .mu.g/mL to about 34 .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 5 mM to about 20 mM, said composition having a pH of between about 4.5 and about 5.5 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.; (b) packaged in pharmaceutical packaging material.

3. A sterile unit dose, comprising: (a) 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 26 .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 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.; (b) packaged in a vial over wrapped with a laminate.

4. A sterile unit dose, comprising: (a) 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 26 .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 50 mM, said composition having a pH of about 5; (b) packaged in a vial over wrapped with a laminate.

5. The sterile unit dose as in any one of claims 1, 2, 3 or 4 further comprising a tonicity adjusting agent.

6. The sterile unit dose of claim 5 wherein said tonicity adjusting agent is sodium chloride.

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

8. A method of oral administration comprising the steps of: (a) adding to a nebulizer, from a propellant-free, sterile unit dose package 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 34 .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 composition prior to administration.

9. A method of oral administration comprising the steps of: (a) adding to a nebulizer from a propellant-free, sterile unit dose package 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 34 .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 composition prior to administration.

10. A method of oral administration comprising the steps of: (a) adding from a propellant-free, sterile unit dose package to a nebulizer 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 26 .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 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.

11. The method of claims 8, 9, or 10 further comprising a tonicity adjusting agent.

12. The method of claim 11 wherein said tonicity adjusting agent is sodium chloride.

13. The method as in any one of claims 8, 9 or 10 wherein said package is selected from the group consisting of blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers and syringes.

14. The method as in any one of claims 8, 9 or 10 wherein said package is a vial.

15. The method of claim 14 wherein said vial is over wrapped with a laminate.

16. The sterile unit dose of claim 1 wherein said formoterol is in the (R) form, or a salt thereof.

17. The sterile unit dose of claim 16 wherein said (R) formoterol is a salt and said salt is a tartrate.

18. The sterile unit dose of claim 1 wherein said formoterol is a tartrate salt.
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