Claims for Patent: 10,772,829

Summary for Patent: 10,772,829

Title:	Aqueous ophthalmic solutions of phentolamine and medical uses thereof
Abstract:	The invention provides aqueous ophthalmic solutions of phentolamine or pharmaceutically acceptable salts thereof, medical kits, and methods for using such ophthalmic solutions to improve visual performance in a patient. Exemplary aqueous ophthalmic solutions include those containing phentolamine mesylate, mannitol, sodium acetate, and water.
Inventor(s):	Meyer Alan
Assignee:	Ocuphire Pharma, Inc.
Application Number:	US16398687
Patent Claims:	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; ande. 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.