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 an ophthalmic disorder or condition in an individual in need thereof, comprising: administering to an eye of the individual an effective amount of an ophthalmic composition comprising from about 0.001 wt % to about 0.05 wt % of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9, wherein the muscarinic antagonist is atropine or atropine sulfate, wherein the ophthalmic composition is not administered through injection, and wherein the ophthalmic disorder or condition is pre-myopia, myopia, or progression of myopia.
2. The method of claim 1 , wherein administration of the ophthalmic composition arrests or slows down myopia progression.
3. The method of claim 1 , wherein the ophthalmic composition has a pD of one of: less than about 7.3, less than about 7.2, less than about 7.1, less than about 7, less than about 6.8, less than about 6.5, less than about 6.4, less than about 6.3, less than about 6.2, less than about 6.1, less than about 6, less than about 5.9, less than about 5.8, less than about 5.2, or less than about 4.8 after extended period of time under storage condition.
4. The method of claim 1 , wherein the ophthalmic composition comprises one of: at least about 80%, at least about 85%, at least about 90%, at least about 93%, at least about 95%, at least about 97%, at least about 98%, or at least about 99% of the muscarinic antagonist based on initial concentration after extended period of time under storage condition.
5. The method of claim 1 , wherein the ophthalmic composition is stored for an extended period of time comprising one of: about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 8 months, about 10 months, about 12 months, about 18 months, about 24 months, about 36 months, about 4 years, or about 5 years.
6. The method of claim 1 , wherein the ophthalmic composition is stored at a storage temperature of from about 2° C. to about 10° C. or from about 16° C. to about 26° C.
7. The method of claim 1 , wherein the muscarinic antagonist is present in the composition at a concentration of one of: from about 0.001 wt % to about 0.04 wt %, from about 0.001 wt % to about 0.03 wt %, from about 0.001 wt % to about 0.025 wt %, from about 0.001 wt % to about 0.02 wt %, from about 0.001 wt % to about 0.01 wt %, from about 0.001 wt % to about 0.008 wt %, or from about 0.001 wt % to about 0.005 wt %.
8. The method of claim 1 , wherein the ophthalmic composition further comprises an osmolarity adjusting agent.
9. The method of claim 8 , wherein the osmolarity adjusting agent is sodium chloride.
10. The method of claim 1 , wherein the ophthalmic composition further comprises a preservative.
11. The method of claim 10 , wherein the preservative is selected from benzalkonium chloride, cetrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or combinations thereof.
12. The method of claim 1 , wherein the ophthalmic composition further comprises a buffer agent.
13. The method of claim 12 , wherein the buffer agent is selected from borates, borate-polyol complexes, phosphate buffering agents, citrate buffering agents, acetate buffering agents, carbonate buffering agents, organic buffering agents, amino acid buffering agents, or combinations thereof.
14. The method of claim 1 , wherein the ophthalmic composition is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof.
15. The method of claim 1 , wherein the ophthalmic composition further comprises a pD adjusting agent.
16. The method of claim 15 , wherein the pD adjusting agent comprises deuterated hydrochloric acid, deuterated sodium hydroxide, deuterated acetic acid, or deuterated citric acid.
17. The method of claim 1 , wherein the ophthalmic composition comprises one of: less than 5% of H 2 O, less than 4% of H 2 O, less than 3% of H 2 O, less than 2% of H 2 O, less than 1% of H 2 O, less than 0.5% of H 2 O, less than 0.1% of H 2 O, or 0% of H 2 O.
18. The method of claim 1 , wherein the ophthalmic composition is topically administered.
19. The method of claim 1 , wherein the ophthalmic composition is administered by instillation.
20. The method of claim 1 , wherein the ophthalmic composition is administered through an eye drop bottle containing the ophthalmic composition.