Fluorescein and benoxinate compositions
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.
1. A kit comprising: (a) a composition, wherein the composition comprises a fluorescein component and a benoxinate component; and (b) a glass container; 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 kit of claim 1 , wherein the total impurity is about 1.5% or less by weight after 12 months of storage.
3. The kit of claim 1 , wherein the total impurity is less than about 1.0% by weight after 12 months of storage.
4. The kit of claim 1 , wherein the total impurity comprises an impurity with a relative retention time of about 0.43.
5. The kit 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 kit of claim 1 , wherein the total impurity comprises an impurity with a relative retention time of about 0.68.
7. The kit 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 kit of claim 1 , wherein the total impurity comprises an impurity with a relative retention time of about 0.74.
9. The kit 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 kit of claim 1 , wherein the total impurity comprises an impurity with a relative retention time of about 0.79.
11. The kit 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 kit of claim 1 , wherein the composition comprises about 0.25% by weight of the fluorescein component.
13. The kit of claim 1 , wherein the fluorescein component comprises fluorescein or the pharmaceutically acceptable salt thereof.
14. The kit of claim 13 , wherein the pharmaceutically acceptable salt of fluorescein is the sodium salt.
15. The kit of claim 1 , wherein the composition comprises about 0.40% by weight of the benoxinate component.
16. The kit of claim 1 , wherein the benoxinate component comprises benoxinate or the pharmaceutically acceptable salt thereof.
17. The kit of claim 16 , wherein the pharmaceutically acceptable salt of benoxinate is the hydrochloride salt.
18. The kit 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 kit of claim 1 , wherein the composition further comprises a preservative.
20. The kit of claim 19 wherein the preservative is chlorobutanol or any other suitable ophthalmic preservative.
21. The kit of claim 1 , wherein the composition is provided as a sterile, aqueous, topical ophthalmic solution.
22. The kit of claim 1 , wherein the glass container has a fill volume of about 5 mL.
23. The kit of claim 1 , wherein the glass container is a glass bottle.
24. The kit of claim 23 , wherein the glass container further comprises a dropper applicator.
25. The kit of claim 24 , wherein the dropper applicator is sterilized.