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. A method of treating progression of myopia or reducing the progression rate of myopia in an individual in need thereof, comprising administering to an eye of the individual a stabilized ophthalmic composition comprising from about 0.001 wt % to about 0.05 wt % of atropine or atropine sulfate and water, wherein the stabilized ophthalmic composition further comprises a buffering agent to provide a pH from about 4.8 to about 6.4, wherein the stabilized ophthalmic composition is a liquid, and wherein the stabilized ophthalmic composition comprises less than about 10% of a degradant formed from degradation of the atropine or atropine sulfate after an extended period of time of at least 2 weeks under a storage temperature of from about 20° C. to about 70° C. and relative humidity from about 50% to about 80%.
2. The method of claim 1 , wherein the atropine or atropine sulfate is present in the stabilized ophthalmic composition at a concentration of from about 0.001 wt % to about 0.03 wt %.
3. The method of claim 1 , wherein the atropine or atropine sulfate is present in the stabilized ophthalmic composition at a concentration of from about 0.01 wt % to about 0.02 wt %.
4. The method of claim 1 , wherein the atropine or atropine sulfate is present in the stabilized ophthalmic composition at a concentration of about 0.01 wt %.
5. The method of claim 1 , wherein the stabilized ophthalmic composition is topically administered.
6. The method of claim 1 , wherein the stabilized ophthalmic composition is administered as eye drops.
7. The method of claim 1 , wherein the stabilized ophthalmic composition is administered at least once a day.
8. The method of claim 1 , wherein the stabilized ophthalmic composition is administered once a day.
9. The method of claim 1 , wherein the stabilized ophthalmic composition is administered by instillation.
10. The method of claim 1 , wherein the stabilized ophthalmic composition further comprises a tonicity agent, a chelator, a viscosity agent, or combinations thereof.
11. The method 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.
12. The method of claim 1 , wherein the buffering agent comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof.
13. The method of claim 10 , wherein the tonicity agent comprises a halide salt of a monovalent cation.
14. The method of claim 10 , wherein the viscosity agent comprises hydroxyethyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl-cellulose (HPMC).
15. The method of claim 1 , wherein the stabilized ophthalmic composition is substantially free of a preservative.
16. The method of claim 1 , wherein the stabilized ophthalmic composition further comprises a preservative.
17. The method of claim 16 , wherein a concentration of the preservative is from about 0.0001% to about 1%.
18. The method of claim 16 , wherein the preservative is selected from benzalkonium chloride, cetrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or combinations thereof.
19. The method of claim 1 , wherein the stabilized ophthalmic composition is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof.
20. A method of treating pre-myopia in an individual in need thereof, comprising administering to an eye of the individual a stabilized ophthalmic composition comprising from about 0.001 wt % to about 0.05 wt % of atropine or atropine sulfate and water, wherein the stabilized ophthalmic composition further comprises a buffering agent to provide a pH from about 4.8 to about 6.4, wherein the stabilized ophthalmic composition is a liquid, and wherein the stabilized ophthalmic composition comprises less than about 10% of a degradant formed from degradation of the atropine or atropine sulfate after an extended period of time of at least 2 weeks under a storage temperature of from about 20° C. to about 70° C. and relative humidity from about 50% to about 80%.
21. The method of claim 20 , wherein the atropine or atropine sulfate is present in the stabilized ophthalmic composition at a concentration of about 0.01 wt %.
22. The method of claim 20 , wherein the stabilized ophthalmic composition is topically administered.
23. The method of claim 20 , wherein the stabilized ophthalmic composition is administered at least once a day.
24. The method of claim 20 , wherein the stabilized ophthalmic composition further comprises a tonicity agent, a chelator, a viscosity agent, a preservative, or combinations thereof.
25. The method of claim 20 , wherein the stabilized ophthalmic composition is substantially free of a preservative.