Aqueous ophthalmic solutions of phentolamine and medical uses thereof

1. An aqueous ophthalmic solution, consisting of:

a. about 0.1% (w/v) to about 4% (w/v) of phentolamine or a pharmaceutically acceptable salt thereof;

b. about 1% (w/v) to about 6% (w/v) of at least one polyol compound selected from the group consisting of mannitol, glycerol, propylene glycol, ethylene glycol, sorbitol, and xylitol;

c. about 0.1 mM to about 10 mM of at least one buffer;

d. water; and

e. optionally one or more of an alkali metal halide or alkaline earth metal halide;

wherein the solution has a pH in the range of 4.0 to 7.5.

2. The solution of claim 1 , wherein the solution has from about 0.25% (w/v) to about 2% (w/v) of phentolamine mesylate.

3. The solution of claim 1 , wherein the solution has from about 0.25% (w/v) to about 1% (w/v) of phentolamine mesylate.

4. The solution of claim 1 , wherein the solution has about 1% (w/v) of phentolamine mesylate.

5. The solution of claim 1 , wherein the solution has about 4% (w/v) of the at least one polyol compound.

6. The solution of claim 3 , wherein the solution has about 4% (w/v) of the at least one polyol compound.

7. The solution of claim 4 , wherein the solution has about 4% (w/v) of the at least one polyol compound.

8. The solution of claim 1 , wherein the at least one polyol compound is mannitol.

9. The solution of claim 4 , wherein the at least one polyol compound is mannitol.

10. The solution of claim 7 , wherein the at least one polyol compound is mannitol.

11. The solution of claim 1 , wherein the buffer is present at a concentration in the range of about 2 mM to about 4 mM.

12. The solution of claim 4 , wherein the buffer is present at a concentration in the range of about 2 mM to about 4 mM.

13. The solution of claim 7 , wherein the buffer is present at a concentration in the range of about 2 mM to about 4 mM.

14. The solution of claim 10 , wherein the buffer is present at a concentration in the range of about 2 mM to about 4 mM.

15. The solution of claim 1 , wherein the buffer is present at a concentration of about 3 mM.

16. The solution of claim 4 , wherein the buffer is present at a concentration of about 3 mM.

17. The solution of claim 7 , wherein the buffer is present at a concentration of about 3 mM.

18. The solution of claim 10 , wherein the buffer is present at a concentration of about 3 mM.

19. The solution of claim 1 , wherein the buffer comprises an alkali metal acetate.

20. The solution of claim 4 , wherein the buffer comprises an alkali metal acetate.

21. The solution of claim 7 , wherein the buffer comprises an alkali metal acetate.

22. The solution of claim 10 , wherein the buffer comprises an alkali metal acetate.

23. The solution of claim 18 , wherein the buffer comprises an alkali metal acetate.

24. The solution of claim 1 , wherein the buffer comprises sodium acetate.

25. The solution of claim 4 , wherein the buffer comprises sodium acetate.

26. The solution of claim 7 , wherein the buffer comprises sodium acetate.

27. The solution of claim 10 , wherein the buffer comprises sodium acetate.

28. The solution of claim 18 , wherein the buffer comprises sodium acetate.

29. The solution of claim 1 , wherein the solution has a pH in the range of 4.5 to 5.5.

30. The solution of claim 4 , wherein the solution has a pH in the range of 4.5 to 5.5.

31. The solution of claim 7 , wherein the solution has a pH in the range of 4.5 to 5.5.

32. The solution of claim 10 , wherein the solution has a pH in the range of 4.5 to 5.5.

33. The solution of claim 18 , wherein the solution has a pH in the range of 4.5 to 5.5.

34. The solution of claim 23 , wherein the solution has a pH in the range of 4.5 to 5.5.

35. The solution of claim 28 , wherein the solution has a pH in the range of 4.5 to 5.5.