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US 12,721,810 B2Granted
Aqueous ophthalmic solutions of phentolamine and medical uses thereof
AssigneeOpus Genetics, Inc.
InventorAlan Meyer
Life of this patent
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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.
Claims30
A method of making an aqueous ophthalmic solution, the method comprising combining:
- a. phentolamine or a pharmaceutically acceptable salt thereof, wherein the phentolamine or a pharmaceutically acceptable salt thereof has a concentration of from about 0.1% (w/v) to about 4% (w/v) in the aqueous ophthalmic solution;
- b. at least one polyol compound selected from the group consisting of mannitol, glycerol, propylene glycol, ethylene glycol, sorbitol, and xylitol;
- c. at least one buffer, wherein said buffer has a concentration of from about 0.1 mM to about 10 mM in the aqueous ophthalmic solution;
- d. water;
- provided the aqueous ophthalmic solution does not contain any additional ingredient that is a chelating agent, and wherein the aqueous ophthalmic solution does not contain any additional ingredient that is a stabilizer.
2 more elements
A method of making an aqueous ophthalmic solution, the method consisting essentially of combining:
- a. phentolamine or a pharmaceutically acceptable salt thereof, wherein the phentolamine or a pharmaceutically acceptable salt thereof has a concentration of from about 0.1% (w/v) to about 4% (w/v) in the aqueous ophthalmic solution;
- b. at least one polyol compound selected from the group consisting of mannitol, glycerol, propylene glycol, ethylene glycol, sorbitol, and xylitol;
- c. at least one buffer, wherein said buffer has a concentration of from about 0.1 mM to about 10 mM in the aqueous ophthalmic solution;
- d. water;
- provided the aqueous ophthalmic solution does not contain any additional ingredient that is a chelating agent;
- and wherein the aqueous ophthalmic solution does not contain any additional ingredient that is a stabilizer;
- wherein optionally the pH of the solution is adjusted to a pH of about 4.0 to about 7.5, and optionally the aqueous ophthalmic solution is stored at a temperature in the range of 2-8° C.
4 more elements
A method of making an aqueous ophthalmic solution, the method consisting of combining:
- a. phentolamine or a pharmaceutically acceptable salt thereof, wherein the phentolamine or a pharmaceutically acceptable salt thereof has a concentration of from about 0.1% (w/v) to about 4% (w/v) in the aqueous ophthalmic solution;
- b. at least one polyol compound selected from the group consisting of mannitol, glycerol, propylene glycol, ethylene glycol, sorbitol, and xylitol;
- c. at least one buffer, wherein said buffer has a concentration of from about 0.1 mM to about 10 mM in the aqueous ophthalmic solution;
- d. water;
- and
- e. optionally one or more of a poly(C2-4 alkylene)glycol polymer, dextran, pharmaceutically acceptable carrier, cellulose agent, carbohydrate, alkali metal halide, alkaline earth metal halide, boric acid, cyclodextrin, dextrose, glycerin, urea, viscosity modifying agent, demulcent polymer, wetting agent, or water-miscible solvent;
- wherein optionally the pH of the solution is adjusted to a pH of about 4.0 to about 7.5, and optionally the aqueous ophthalmic solution is stored at a temperature in the range of 2-8° C.
4 more elements
A method of making an aqueous ophthalmic solution, the method consisting essentially of combining:
- a. phentolamine or a pharmaceutically acceptable salt thereof, wherein the phentolamine or a pharmaceutically acceptable salt thereof has a concentration of from about 0.1% (w/v) to about 4% (w/v) in the aqueous ophthalmic solution;
- b. at least one polyol compound selected from the group consisting of mannitol, glycerol, propylene glycol, ethylene glycol, sorbitol, and xylitol;
- c. at least one buffer, wherein said buffer has a concentration of from about 0.1 mM to about 10 mM in the aqueous ophthalmic solution;
- d. water;
- and
- e. optionally one or more of an alkali metal halide or alkaline earth metal halide;
- provided the aqueous ophthalmic solution does not contain any additional ingredient that is a chelating agent;
- and wherein the aqueous ophthalmic solution does not contain any additional ingredient that is a stabilizer;
- wherein optionally the pH of the solution is adjusted to a pH of about 4.0 to about 7.5, and optionally the aqueous ophthalmic solution is stored at a temperature in the range of 2-8° C.
6 more elements
Dependencies are inferred from the claim text.