Pharmaceutical formulation containing umeclidinium bromide and vilanterol trifenatate

1. A liquid, propellant-free pharmaceutical formulation comprising:

(a) umeclidinium bromide and vilanterol trifenatate;

(b) a solvent;

(c) a pharmacologically acceptable solubilizing agent,

wherein the pH of the formulation ranges from about 2.5 to about 6.

2. The pharmaceutical formulation of claim 1 , wherein the umeclidinium bromide is present in an amount ranging from about 2 mg/100 ml to about 1050 mg/100 ml.

3. The pharmaceutical formulation of claim 1 , wherein the vilanterol trifenatate is present in an amount ranging from about 1 mg/100 ml to about 550 mg/100 ml.

4. The pharmaceutical formulation of claim 1 , wherein the solvent is water.

5. The pharmaceutical formulation of claim 1 , wherein the solubilizing agent is selected from the group consisting of tween-80 and cyclodextrin derivatives.

6. The pharmaceutical formulation of claim 1 , wherein the solubilizing agent is present in an amount ranging from about 1 g/100 ml to about 40 g/100 ml.

7. The pharmaceutical formulation of claim 6 , wherein the solubilizing agent is sulfobutylether β-cyclodextrin in an amount ranging from about 1 g/100 ml to about 40 g/100 ml.

8. The pharmaceutical formulation of claim 1 , further comprising a preservative selected from the group consisting of benzalkonium chloride, benzoic acid, and sodium benzoate.

9. The pharmaceutical formulation of claim 8 , wherein the preservative is present in an amount ranging from about 2 mg/100 ml to about 300 mg/100 ml.

10. The pharmaceutical formulation of claim 1 , further comprising a stabilizer selected from the group consisting of edetic acid, edetate disodium dehydrate, edetate disodium, citric acid, and combinations thereof.

11. The pharmaceutical formulation of claim 1 , wherein the stabilizer is present in an amount ranging from about 1 mg/100 ml to about 500 mg/100 ml.

12. A method for administering the pharmaceutical formulation of claim 1 comprising nebulizing a defined amount of the pharmaceutical formulation with an inhaler by using pressure to force the pharmaceutical preparation through a nozzle to form an inhalable aerosol.

13. The method of claim 12 , wherein the defined amount of the pharmaceutical formulation is less than about 70 microliters.

14. The method of claim 12 , wherein the mass median aerodynamic diameter (MMAD) of vilanterol trifenatate and umeclidinium bromide are less than about 10 μm.

15. The method of claim 12 , wherein the geometric standard deviation (GSD) of vilanterol trifenatate and umeclidinium bromide are less than about 5%.

16. The method of claim 12 , wherein the aerosol has a particle size distribution having a Dv(10) of less than about 4 μm, a Dv(50) of less than about 7 μm, and a Dv(90) of less than about 12 μm.

17. The method of claim 12 , wherein the pharmaceutical formulation is administered using an inhaler as depicted in FIG. 1 .

18. A method of treating asthma or COPD in a patient, comprising administering to the patient the pharmaceutical formulation of claim 1 by inhalation.

19. The method of claim 18 , wherein the daily dose of umeclidinium bromide is about 15 micrograms to about 110 micrograms and the daily dose of vilanterol trifenatate is about 9 micrograms to about 60 micrograms.

20. A liquid, propellant-free pharmaceutical formulation comprising:

an aqueous solution of:

(a) umeclidinium bromide in an amount of about 2 mg/100 mL to about 1050 mg/100 mL of the formulation;

(b) vilanterol trifenatate in an amount of about 1 mg/100 mL to about 550 mg/100 mL of the formulation;

(c) sulfobutylether β-cyclodextrin (SBECD) in an amount of about 1 g/100 mL to about 40 g/100 mL of the formulation;

(d) sodium chloride in an amount of about 100 mg/100 mL to about 900 mg/100 mL of the formulation;

wherein the pH of the solution ranges from about 2.5 to about 6.