# US 12,594,240 B2 · Artificial vitreous humor for the investigation of drugs and drug formulations > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,240 B2 - Document ID: US12594240B2 - Status: Granted - Kind: B2 - Application number: 18/298,991 - Filed: 2023-04-11 - Published: 2024-03-07 - Granted: 2026-04-07 - Earliest claimed: 2017-10-25 - Applicants: Hoffmann-La Roche Inc. - Inventors: Ulrike Altenburger; Sulabh Pravinchandra Patel; Gregoire Schwach; Pankaj Shende - Web page: https://patentgrep.com/patent/US12594240B2 ## CPC - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 9/0048: {Eye, e.g. artificial tears} - A61K 47/02: Inorganic compounds - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34) - 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) ## Abstract The invention relates to an artificial vitreous humor composition comprising a phosphate buffer, wherein the phosphate buffer has a pH value in the range from 7.0 to 7.7, particularly from 7.1 to 7.6, more particularly from 7.2 to 7.5. The invention further relates to a method of production of an artificial vitreous humor composition, a method for analyzing the behavior of a substance, a method for analyzing the change of the artificial vitreous humor composition upon contact with a substance and a kit of parts. ## Claims ### Claim 1 A method for analyzing the behavior of a substance comprising the steps in order: (i) providing an artificial vitreous humor composition in an in vitro environment; (ii) applying the substance to the artificial vitreous humor; and (iii) determining at least one property of the applied substance, wherein the artificial vitreous humor composition comprises, (A) a phosphate buffer, wherein the phosphate buffer is phosphate buffer saline (PBS) in the range from 0.001 to 0.2 M and has a pH value in the range from 7.0 to 7.7, (B) 64.6 μM creatinine, 2.2 mM glucose, 7.6 mM urea, 580 μM xanthine, 309 μM hypoxanthine, 10.5 mM sodium lactate and 200 μM glutathione, and (C) 40 mg/L type II collagen and 0.6% w/v sodium hyaluronate, and wherein the applied substance is left in the artificial vitreous humor composition for up to 360 days, prior to step (iii) and the artificial vitreous humor composition remains at a pH having a value in the range from 7.0 to 7.7. ### Claim 2 (depends on 1) The method of claim 1, wherein the substance to be applied is at least one of a macromolecule, a drug formulation, an excipient, a protein or a combination thereof. ### Claim 3 (depends on 1) The method of claim 1, wherein the substance to be applied comprises molecules having a size in a range between 100 Da and 1800 kDa. ### Claim 4 (depends on 1) The method of claim 1, wherein the at least one property of the applied substance is selected from the group consisting of stability, bioavailability, release from drug-loaded long acting delivery (DDS) system and degradation of DDS system. ### Claim 5 A method for analyzing the behavior of an artificial humor composition comprising the steps in order: (i) providing an artificial vitreous humor composition in an in vitro environment; (ii) applying a substance to the artificial vitreous humor; and (iii) determining at least one property of the artificial humor composition, wherein the artificial vitreous humor composition comprises, (A) a phosphate buffer, wherein the phosphate buffer is phosphate buffer saline (PBS) in the range from 0.001 to 0.2 M and has a pH value in the range from 7.0 to 7.7, (B) 64.6 μM creatinine, 2.2 mM glucose, 7.6 mM urea, 580 μM xanthine, 309 μM hypoxanthine, 10.5 mM sodium lactate and 200 μM glutathione, and (C) 40 mg/L type II collagen and 0.6% w/v sodium hyaluronate, and wherein the applied substance is left in the artificial vitreous humor composition for up to 360 days, prior to step (iii) and the artificial vitreous humor composition remains at a pH having a value in the range from 7.0 to 7.7.