Fluorescein and benoxinate compositions
View Patent ↗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 from about 0.20% to about 0.30% by weight of a fluorescein component and from about 0.32% to about 0.48% by weight a benoxinate component; and
(b) a glass container;
wherein the composition comprises no more than about 0.7% by weight of 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 composition comprises no more than about 0.7% by weight of impurities with relative retention times from about 0.10 to about 1.90 under HPLC Method A after 12 months of storage.
3. The kit of claim 1 , wherein the composition comprises no more than about 0.6% by weight of impurities with relative retention times from about 0.10 to about 1.90 under HPLC Method A after 18 months of storage.
4. The kit of claim 1 , wherein the impurities with relative retention times from about 0.10 to about 1.90 under HPLC Method A 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 0.6% by weight after 12 months of storage.
6. The kit of claim 1 , wherein the impurities with relative retention times from about 0.10 to about 1.90 under HPLC Method A 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 0.6% by weight after 12 months of storage.
8. The kit of claim 1 , wherein the impurities with relative retention times from about 0.10 to about 1.90 under HPLC Method A 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 0.6% by weight after 12 months of storage.
10. The kit of claim 1 , wherein the impurities with relative retention times from about 0.10 to about 1.90 under HPLC Method A 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 0.6% 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 12 , wherein the fluorescein component comprises fluorescein sodium salt.
14. The kit of claim 1 , wherein the composition comprises about 0.40% by weight of the benoxinate component.
15. The kit of claim 14 , wherein the benoxinate component comprises benoxinate hydrochloride salt.
16. 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.
17. The kit of claim 1 , wherein the composition further comprises a preservative.
18. The kit of claim 17 wherein the preservative is chlorobutanol or any other suitable ophthalmic preservative.
19. The kit of claim 1 , wherein the composition is provided as a sterile, aqueous, topical ophthalmic solution.
20. The kit of claim 1 , wherein the glass container has a fill volume of about 5 mL.