Pharmaceutical formulations and compositions of a selective antagonist of either CXCR2 or both CXCR1 and CXCR2 and methods of using the same for treating inflammatory disorders

1. A composition comprising Compound I or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient which provides release of at least 83% Compound I in 5 minutes when tested using a USPII Paddle Stirrer apparatus filled with 900 mL of dissolution medium consisting of 0.5% sodium lauryl sulfate solution buffered with pH 6.8 sodium phosphate buffer at 37° C.±0.5° C. with the paddle speed set at 75 RPM, wherein Compound I has the chemical structure

and wherein the at least one pharmaceutically acceptable excipient is

one or more wetting agent(s), which is sodium lauryl sulfate present in a range of 0.1% to 5% (w/w),

one or more binder(s), which is povidone present in a ratio of povidone to Compound I of between 0.18:1 to 1.8:1,

one or more diluent(s), and

one or more disintegrant(s), which is crospovidone present at about 2% to about 30% (w/w); and

wherein the composition is a capsule.

2. The composition of claim 1 , which provides release of at least 99% Compound I in 15 minutes.

3. The composition of claim 1 , wherein the composition is color stable as assessed by comparing the color of a first sample taken after blending Compound I, one or more wetting agent(s), one or more binder(s), one or more diluent(s), and one or more disintegrant(s) in a fluid bed with a second sample taken after loss on drying 4% reached under an inlet air temperature of 70° C. and the second sample is continued to dry under the inlet air temperature of 70° C. for at least 80 minutes.

4. The composition of claim 1 , wherein one or more wetting agent(s) is sodium lauryl sulfate present in a ratio of sodium lauryl sulfate to Compound I of about 1 to 10.

5. The composition of claim 1 , wherein one or more wetting agent(s) is sodium lauryl sulfate present in a range of about 0.1% to about 2% (w/w).

6. The composition of claim 1 , wherein one or more binder(s) is povidone present at about 0.1% to about 20% (w/w).

7. The composition of claim 1 , wherein one or more binder(s) is povidone present in a ratio of povidone to Compound I of between about 0.66 to 1.

8. The composition of claim 1 , wherein one or more binder(s) is povidone present at about 0.3% to about 5% (w/w).

9. The composition of claim 1 wherein one or more diluent(s) is present at about 10% to about 90% (w/w).

10. The composition of claim 9 , wherein one or more diluent(s) is microcrystalline cellulose and lactose.

11. The composition of claim 1 , further comprising one or more glidant(s).

12. The composition of claim 11 , wherein one or more glidant(s) is present at about 0.1% to about 5% (w/w).

13. The composition of claim 11 , wherein one or more glidant(s) is silicon dioxide.

14. The composition of claim 1 , further comprising one or more lubricant(s).

15. The composition of claim 14 , wherein one or more lubricant(s) is present at about 0.2% to about 5% (w/w).

16. A composition comprising the following components:

mg per unit dose of

Components

composition

Compound I

10

Lactose Monohydrate

108.02

Microcrystalline Cellulose

35.2

Crospovidone

16.5

Povidone

5.28

Sodium Lauryl Sulfate

1

wherein Compound I has the chemical structure

and

wherein the composition is a capsule.

17. The composition of claim 16 , further comprising the following components:

mg per unit dose of

Components

composition

Microcrystalline Cellulose

24.2

Crospovidone

16.5.

18. The composition of claim 16 , further comprising the following components:

mg per unit dose of

Components

composition

Silicon Dioxide

2.2

Magnesium Stearate

1.1.

19. The composition of claim 1 , which exhibits a mean AUC of Compound I between about 484 ng.hr/ml and about 489 ng.hr/ml following a single-dose oral administration of 30 mg Compound I to a human.

20. The composition of claim 1 , which exhibits a mean Cmax of Compound I between about 122 ng/ml and about 147 ng/ml following a single-dose oral administration of 30 mg Compound I to a human.

21. The composition of claim 1 , which exhibits a median Tmax of Compound I between about 0.5 and about 2 hours following oral administration to a human.

22. A method for treating an inflammatory disorder in a patient suffering therefrom comprising administering the composition of claim 1 , wherein the inflammatory disorder is selected from acute inflammatory pain, arthritis, chronic obstructive pulmonary disease (COPD), psoriasis, and asthma.

23. The composition of claim 1 , wherein one or more binder(s) is povidone present at about 2% to about 3% (w/w).

24. The method of claim 22 , wherein the inflammatory disorder is chronic obstructive pulmonary disease (COPD).