Claims for Patent: 10,842,872
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Summary for Patent: 10,842,872
| Title: | Fluorescein and benoxinate compositions |
| Abstract: | Compositions comprising a fluorescein component and benoxinate component and the corresponding uses of these compositions are described herein. These compositions have improved storage life and the fluorescein component and/or benoxinate component minimally degrade after 12 to 18 months of storage. |
| Inventor(s): | Witham; Patrick H. (Eugene, OR), Machiraju; Sailaja (Beaverton, OR) |
| Assignee: | PARAGON BIOTECK, INC. (Portland, OR) |
| Application Number: | 16/820,593 |
| Patent Claims: |
1. A method for administering a disclosing agent and an anesthetic to an eye of a subject in need of an ophthalmic procedure, comprising topically administering to the eye
of the subject a composition comprising: (a) a fluorescein component; and (b) a benoxinate component; wherein the composition comprises a total impurity of about 1.5% or less by weight, and wherein the total impurity comprises one or more impurities
with relative retention times from about 0.10 to about 1.90 under HPLC Method A.
2. The method of claim 1, wherein the total impurity is about 1.5% or less by weight after 12 months of storage. 3. The method of claim 1, wherein the total impurity is less than about 1.0% by weight after 12 months of storage. 4. The method of claim 1, wherein the total impurity comprises an impurity with a relative retention time of about 0.43. 5. The method of claim 4, wherein the impurity with a relative retention time of about 0.43 is less than about 1.0% by weight after 12 months of storage. 6. The method of claim 1, wherein the total impurity comprises an impurity with a relative retention time of about 0.68. 7. The method of claim 6, wherein the impurity with a relative retention time of about 0.68 is less than about 1.0% by weight after 12 months of storage. 8. The method of claim 1, wherein the total impurity comprises an impurity with a relative retention time of about 0.74. 9. The method of claim 8, wherein the impurity with a relative retention time of about 0.74 is less than about 1.0% by weight after 12 months of storage. 10. The method of claim 1, wherein the total impurity comprises an impurity with a relative retention time of about 0.79. 11. The method of claim 10, wherein the impurity with a relative retention time of about 0.79 is less than about 1.0% by weight after 12 months of storage. 12. The method of claim 1, wherein the composition comprises about 0.25% by weight of the fluorescein component. 13. The method of claim 1, wherein the fluorescein component comprises fluorescein or the pharmaceutically acceptable salt thereof. 14. The method of claim 13, wherein the pharmaceutically acceptable salt of fluorescein is the sodium salt. 15. The method of claim 1, wherein the composition comprises about 0.40% by weight of the benoxinate component. 16. The method of claim 1, wherein the benoxinate component comprises benoxinate or the pharmaceutically acceptable salt thereof. 17. The method of claim 16, wherein the pharmaceutically acceptable salt of benoxinate is the hydrochloride salt. 18. The method of claim 1, wherein the composition further comprises one or more inactive agents selected from boric acid, povidone, purified water, and hydrochloric acid. 19. The method of claim 1, wherein the composition further comprises a preservative. 20. The method of claim 19 wherein the preservative is chlorobutanol or any other suitable ophthalmic preservative. 21. The method of claim 1, wherein the ophthalmic procedure is a conjunctival procedure, a corneal procedure, a tear fluid dynamics evaluation, or a gonioscopy. 22. The method of claim 1, wherein the procedure is tonometry. 23. The method of claim 1, wherein the anesthetizing is corneal anesthesis. |
