# US 11,998,603 B2 · Fluorescein and benoxinate compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,603 B2 - Document ID: US11998603B2 - Status: Granted - Kind: B2 - Application number: 17/953,241 - Filed: 2022-09-26 - Published: 2023-08-24 - Granted: 2024-06-04 - Earliest claimed: 2017-11-15 - Applicants: Paragon BioTeck, Inc. - Inventors: Patrick H. Witham; Sailaja Machiraju - Web page: https://patentgrep.com/patent/US11998603B2 ## CPC - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61B 3/16: for measuring intraocular pressure, e.g. tonometers - A61K 9/0048: {Eye, e.g. artificial tears} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 31/245: Amino benzoic acid types, e.g. procaine, novocaine (salicylic acid esters A61K31/60) - A61K 47/02: Inorganic compounds - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - A61K 49/0004: {Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions} - A61K 49/0043: {Fluorescein, used in vivo} - A61K 49/006: {Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 4) 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. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 6) 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. ### Claim 8 (depends on 1) 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. ### Claim 9 (depends on 8) 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. ### Claim 10 (depends on 1) 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. ### Claim 11 (depends on 10) 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. ### Claim 12 (depends on 1) The kit of claim 1, wherein the composition comprises about 0.25% by weight of the fluorescein component. ### Claim 13 (depends on 12) The kit of claim 12, wherein the fluorescein component comprises fluorescein sodium salt. ### Claim 14 (depends on 1) The kit of claim 1, wherein the composition comprises about 0.40% by weight of the benoxinate component. ### Claim 15 (depends on 14) The kit of claim 14, wherein the benoxinate component comprises benoxinate hydrochloride salt. ### Claim 16 (depends on 1) 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. ### Claim 17 (depends on 1) The kit of claim 1, wherein the composition further comprises a preservative. ### Claim 18 (depends on 17) The kit of claim 17 wherein the preservative is chlorobutanol or any other suitable ophthalmic preservative. ### Claim 19 (depends on 1) The kit of claim 1, wherein the composition is provided as a sterile, aqueous, topical ophthalmic solution. ### Claim 20 (depends on 1) The kit of claim 1, wherein the glass container has a fill volume of about 5 mL.