OPHTHALMIC COMPOSITION
Provided herein is an ophthalmic composition. In some embodiments, the ophthalmic composition includes a low concentration of an ophthalmic agent for treatment of an ophthalmic disorder or condition; and an ophthalmically acceptable carrier, wherein the ophthalmic agent is distributed with substantial uniformity throughout the ophthalmically acceptable carrier. Further disclosed herein include an ophthalmic composition including a low concentration of an ophthalmic agent and deuterated water. Also disclosed herein are methods of arresting or preventing myopia development by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein.
1 . An aqueous solution comprising: (a) atropine or atropine sulfate and less than about 10% of a degradant of atropine or atropine sulfate formed from degradation of the atropine or atropine sulfate and (b) a buffering agent.
2 . The aqueous solution of claim 1 , wherein the atropine or atropine sulfate is present in the aqueous solution at a concentration of from about 0.01 mg/g to about 0.5 mg/g, from about 0.01 mg/g to about 0.3 mg/g, or from about 0.1 mg/g to about 0.2 mg/g.
3 . The aqueous solution of claim 1 , wherein the atropine or atropine sulfate is present in the aqueous solution at a concentration of about 0.1 mg/g, about 0.2 mg/g, about 0.25 mg/g, about 0.3 mg/g, about 0.4 mg/g, or about 0.5 mg/g.
4 . (canceled)
5 . The aqueous solution of claim 1 , wherein the buffering agent comprises a borate, a borate-polyol complex, a phosphate buffering agent, a citrate buffering agent, an acetate buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering agent, or a combination thereof.
6 . The aqueous solution of claim 1 , wherein the buffering agent comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof.
7 . The aqueous solution of claim 1 , wherein the aqueous solution further comprises a tonicity adjusting agent.
8 . The aqueous solution of claim 7 , wherein the tonicity adjusting agent comprises a halide salt of a monovalent cation.
9 . The aqueous solution of claim 1 , wherein the aqueous solution further comprises a viscosity agent.
10 . The aqueous solution of claim 9 , wherein the viscosity agent comprises hydroxyethyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl-cellulose (HPMC).
11 . The aqueous solution of claim 1 , wherein the aqueous solution is substantially free of a preservative.
12 . The aqueous solution of claim 1 , wherein the aqueous solution further comprises a preservative.
13 . The aqueous solution of claim 12 , wherein a concentration of the preservative is from about 0.0001% to about 1%.
14 . The aqueous solution of claim 12 , wherein the preservative is selected from benzalkonium chloride, cetrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or combinations thereof.
15 . The aqueous solution of claim 1 , wherein the aqueous solution is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof.
16 . The aqueous solution of claim 1 , wherein the aqueous solution is sterile.
17 . The aqueous solution of claim 1 , wherein the aqueous solution is stored at a temperature of about 25° C.
18 . The aqueous solution of claim 1 , wherein the aqueous solution is stored at relative humidity from about 60% to about 75%.
19 . The aqueous solution of claim 1 , wherein the aqueous solution has a pH of from about 3.8 to about 6.4.
20 . The aqueous solution of claim 1 , wherein the aqueous solution is an ophthalmic composition.
21 . The aqueous solution of claim 1 , wherein the aqueous solution has a pH of less than 5.
22 . The aqueous solution of claim 1 , wherein the aqueous solution further comprises a stabilizing agent.
23 . The aqueous solution of claim 22 , wherein the stabilizing agent is selected from the group consisting of glycerol, methionine, monothioglycerol, Ethylenediaminetetraacedc acid (EDTA), ascorbic acid, polysorbate 80, polysorbate 20, arginine, heparin, dextran sulfate, cyclodextrins, pentosan polysulfate, magnesium, zinc and combinations thereof.
24 . The aqueous solution of claim 23 , wherein the stabilizing agent is EDTA.