Claims for Patent: 10,479,686

Summary for Patent: 10,479,686

Title:	Sodium thiosulfate-containing pharmaceutical compositions
Abstract:	Provided herein are pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-purgeable organic carbon in a sodium thiosulfate-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium thiosulfate. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium thiosulfate.
Inventor(s):	Sherman; Craig (Scottsdale, AZ), Smith; Catherine Marie (Grafton, WI), Wirtz; Kevin Robert (Belgium, WI), Schulze; Erich (Mission Viejo, CA)
Assignee:	Hope Medical Enterprises, Inc. (Scottsdale, AZ)
Application Number:	15/916,950
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,479,686
Patent Claims:	1. A pharmaceutical composition comprising sodium thiosulfate pentahydrate and one or more pharmaceutically acceptable carriers or excipients, wherein the sodium thiosulfate pentahydrate contains no greater than 8 ppm of non-purgeable organic carbon, contains no greater than 0.05 ppm of mercury, contains no greater than 2 ppm of aluminum, contains no greater than 0.003% by weight of selenium, contains no less than 98% by weight and no greater than about 102% by weight of sodium thiosulfate on an anhydrous basis measured by ion chromatography, has a water content between 32% and 37% by weight, has a heavy metal content of no greater than 10 ppm, contains no greater than 200 ppm of chloride, contains no greater than 0.001% by weight of sulfide, contains no greater than 0.002% by weight of iron, contains no greater than 0.01% by weight of calcium, contains no greater than 0.005% by weight of potassium, contains no greater than 0.1% of sulfite, contains no greater than 0.5% of sulfate, contains no greater than 3 ppm of arsenic, contains no greater than 0.001% by weight of lead, has total aerobic count of microbial load of no greater than 100 CFU/g, has total yeast and mold count of no greater than 20 CFU/g, contains no greater than 0.02 EU/mg of bacterial endotoxins, contains no greater than 0.002% by weight of nitrogen compounds, contains no greater than 0.005% by weight of insoluble matter, contains no greater than 0.01% by weight of residual anti-caking agent, and contains no greater than ICH Q3C (R3) limits of organic volatile impurities, wherein a 10% aqueous solution of the solid sodium thiosulfate pentahydrate at 25.degree. C. is colorless and has a pH between 6.0 and 8.0, and wherein the solid sodium thiosulfate pentahydrate is odorless crystals, wherein the pharmaceutical composition is formulated for parenteral administration; and wherein the pharmaceutically acceptable carrier or excipient is an aqueous vehicle; a water-miscible vehicle; a non-aqueous vehicle; an antimicrobial agent or preservative against the growth of microorganisms; a stabilizer; a solubility enhancer; an isotonic agent; a buffering agent; an antioxidant; a local anesthetic; a suspending or dispersing agent; a wetting or emulsifying agent; a complexing agent; a sequestering or chelating agent; a cryoprotectant; a lyoprotectant; a thickening agent; a pH adjusting agent; or an inert gas. 2. The pharmaceutical composition of claim 1, wherein the sodium thiosulfate pentahydrate has a positive identification test for sodium. 3. The pharmaceutical composition of claim 1, wherein the sodium thiosulfate pentahydrate has a positive identification test for thiosulfate. 4. The pharmaceutical composition of claim 1, wherein the composition is formulated as a single dosage form. 5. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable carrier or excipient is an aqueous vehicle. 6. The pharmaceutical composition of claim 5, wherein the aqueous vehicle is water, saline, physiological saline, phosphate buffered saline, sodium chloride injection, Ringers injection, isotonic dextrose injection, sterile water injection, dextrose or lactated Ringers injection. 7. The pharmaceutical composition of claim 1, wherein the non-aqueous vehicle is a fixed oil of vegetable origin, castor oil, corn oil, cottonseed oil, olive oil, peanut oil, peppermint oil, safflower oil, sesame oil, soybean oil, hydrogenated vegetable oil, hydrogenated soybean oil, medium-chain triglycerides of coconut oil, or palm seed oil. 8. The pharmaceutical composition of claim 1, wherein the water-miscible vehicle is ethanol, 1,3-butanediol, liquid polyethylene glycol, propylene glycol, glycerin, N-methyl-2-pyrrolidone, N,N-dimethylacetamide, or dimethyl sulfoxide. 9. The pharmaceutical composition of claim 8, wherein the liquid polyethylene glycol is polyethylene glycol 300 or polyethylene glycol 400. 10. The pharmaceutical composition of claim 1, wherein the antimicrobial agent or preservative against the growth of microorganisms is a phenol, a cresol, a mercurial, benzyl alcohol, chlorobutanol, methyl propyl p-hydroxybenzoate, propyl p-hydroxybenzoate, thimerosal, benzalkonium chloride, benzethonium chloride, a methyl-paraben, a propyl-paraben, or sorbic acid. 11. The pharmaceutical composition of claim 1, wherein the isotonic agent is potassium chloride, mannitol, sodium chloride, dextran, glucose, glycerin, or dextrose. 12. The pharmaceutical composition of claim 1, wherein the buffering agent is phosphate or citrate. 13. The pharmaceutical composition of claim 1, wherein the antioxidant is bisulfite or sodium metabisulfite. 14. The pharmaceutical composition of claim 1, wherein the local anesthetic is procaine hydrochloride. 15. The pharmaceutical composition of claim 1, wherein the suspending or dispersing agent is sodium carboxymethylcelluose, hydroxypropyl methylcellulose, or polyvinylpyrrolidone. 16. The pharmaceutical composition of claim 1, wherein the emulsifying agent is polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monooleate 80, or triethanolamine oleate. 17. The pharmaceutical composition of claim 1, wherein the sequestering or chelating agent is EDTA. 18. The pharmaceutical composition of claim 1, wherein the pH adjusting agent is an acid or a base. 19. The pharmaceutical composition of claim 18, wherein the acid is boric acid, hydrochloric acid, citric acid or lactic acid and the base is sodium hydroxide. 20. The pharmaceutical composition of claim 1, wherein the complexing agent is a cyclodextrin. 21. The pharmaceutical composition of claim 20, wherein the cyclodextrin is .alpha.-cyclodextrin, .beta.-cyclodextrin, hydroxypropyl-.beta.-cyclodextrin, sulfobutylether-.beta.-cyclodextrin, and sulfobutylether 7-.beta.-cyclodextrin.