# US 11,998,604 B2 · Therapeutic uses for sodium thiosulfate formulations > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,604 B2 - Document ID: US11998604B2 - Status: Granted - Kind: B2 - Application number: 17/992,703 - Filed: 2022-11-22 - Published: 2023-03-30 - Granted: 2024-06-04 - Earliest claimed: 2018-07-03 - Assignees: Fennec Pharmaceuticals Inc. - Applicants: Fennec Pharmaceuticals Inc. - Inventors: Alexander Smith - Web page: https://patentgrep.com/patent/US11998604B2 ## CPC - A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids - 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 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} - A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof - A61K 33/243: Platinum; Compounds thereof - A61K 47/02: Inorganic compounds - A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61P 35/00: Antineoplastic agents - C01B 17/64: Thiosulfates; Dithionites; Polythionates - 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 - C01P 2002/72: by d-values or two theta-values, e.g. as X-ray diagram - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C01B: NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; {METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C} - C01P: INDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS ## Abstract Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum-based chemotherapeutics. ## Claims ### Claim 1 A method of reducing ototoxicity in a human patient receiving a platinum based chemotherapeutic for the treatment of cancer sensitive to the platinum based chemotherapeutic comprising administering an effective amount of a pharmaceutical composition comprising aqueous anhydrous sodium thiosulfate, wherein the aqueous anhydrous sodium thiosulfate is at a concentration of about 0.5 M and further comprising about 0.004 M boric acid. ### Claim 2 (depends on 1) The method of claim 1, wherein the pharmaceutical composition further comprises hydrochloric acid. ### Claim 3 (depends on 1) The method of claim 1, wherein the pharmaceutical composition further comprises sodium hydroxide. ### Claim 4 (depends on 1) The method of claim 1, wherein the pharmaceutical composition has a pH between about 5 and about 9.5. ### Claim 5 (depends on 1) The method of claim 1, wherein the pharmaceutical composition has a pH between about 6.5 and about 8.9. ### Claim 6 (depends on 1) The method of claim 1, wherein the pharmaceutical composition has a pH between about 8.6 and about 8.8. ### Claim 7 (depends on 1) The method of claim 1, wherein the patient is a pediatric patient. ### Claim 8 (depends on 7) The method of claim 7, wherein the pediatric patient is five or fewer years of age. ### Claim 9 (depends on 7) The method of claim 7, wherein the pharmaceutical composition further comprises hydrochloric acid. ### Claim 10 (depends on 7) The method of claim 7, wherein the pharmaceutical composition further comprises sodium hydroxide. ### Claim 11 (depends on 7) The method of claim 7, wherein the pharmaceutical composition has a pH between about 5 and about 9.5. ### Claim 12 (depends on 7) The method of claim 7, wherein the pharmaceutical composition has a pH between about 6.5 and about 8.9. ### Claim 13 (depends on 7) The method of claim 7, wherein the pharmaceutical composition has a pH between about 8.6 and about 8.8. ### Claim 14 (depends on 7) The method of claim 7, wherein the platinum based chemotherapeutic is cisplatin. ### Claim 15 (depends on 14) The method of claim 14, wherein cisplatin is administered to the human patient as an infusion over 1 to 6 hours. ### Claim 16 (depends on 15) The method of claim 15, wherein the pharmaceutical composition is administered to the human patient about 6 hours after the completion of the administration of cisplatin. ### Claim 17 (depends on 16) The method of claim 16, wherein the pharmaceutical composition is administered as an infusion over about 15 minutes. ### Claim 18 (depends on 7) The method of claim 7, wherein the pediatric patient has hepatoblastoma. ### Claim 19 (depends on 7) The method of claim 7, wherein the pediatric patient has medulloblastoma. ### Claim 20 (depends on 7) The method of claim 7, wherein the pediatric patient has neuroblastoma. ### Claim 21 (depends on 7) The method of claim 7, wherein the pediatric patient has osteosarcoma. ### Claim 22 (depends on 7) The method of claim 7, wherein the pediatric patient has a localized cancer. ### Claim 23 (depends on 7) The method of claim 7, wherein the pediatric patient has a disseminated cancer. ### Claim 24 (depends on 7) The method of claim 7, wherein the pediatric patient has a germ cell tumor. ### Claim 25 (depends on 24) The method of claim 24, wherein the germ cell tumor is testicular cancer. ### Claim 26 (depends on 24) The method of claim 24, wherein the germ cell tumor is ovarian cancer.