# US 11,306,158 B1 · Method for preparing high-purity sugammadex sodium > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,306,158 B1 - Document ID: US11306158B1 - Status: Granted - Kind: B1 - Application number: 17/612,203 - Filed: 2020-05-15 - Granted: 2022-04-19 - Earliest claimed: 2019-05-22 - Assignees: Hefei Bosikc Pharmtech Co., Ltd. - Applicants: Hefei Bosikc Pharmtech Co., Ltd. - Inventors: Hui Guo; Youling Wu - Web page: https://patentgrep.com/patent/US11306158B1 ## CPC - C08B 37/0012: {Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof} - A61K 31/724: Cyclodextrins - A61P 21/00: Drugs for disorders of the muscular or neuromuscular system - 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 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - C08B: POLYSACCHARIDES; DERIVATIVES THEREOF (polysaccharides containing less than six saccharide radicals attached to each other by glycosidic linkages C07H; fermentation or enzyme-using processes C12P19/00; sugar industry C13; production of cellulose D21) - 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 ## Abstract A method for preparing high-purity sugammadex sodium, which realizes the preparation by using inositol phosphate and derivatives thereof, includes: adding a specific type of protective agent to crude sugammadex sodium, and performing recrystallization under the protection of inert gas to obtain pure sugammadex sodium. The protective agent is selected from inositol phosphate and derivatives thereof, such as inositol hexaphosphate and salts or esters thereof; one or a mixture of two or more of partial degradation products of inositol hexaphosphate, such as inositol pentaphosphate, inositol tetraphosphate, inositol triphosphate, inositol diphosphate, inositol monophosphate, and salts or esters thereof, in any ratio. The method has the advantages of simple operation, high product purity, good safety and less allergic reaction, and the method is cost-effective and more suitable for industrial production. ## Claims ### Claim 1 A method for preparing high-purity sugammadex sodium, comprising: adding a protective agent to crude sugammadex sodium, and performing a recrystallization under a protection of inert gas to obtain pure sugammadex sodium, wherein the protective agent is selected from inositol phosphate expressed by the following general formula and derivatives thereof: ### Claim 2 (depends on 1) The method for preparing the high-purity sugammadex sodium according to claim 1, wherein the inositol phosphate and the derivatives thereof are inositol hexaphosphate and salts or esters thereof; or one or a mixture of two or more of partial degradation products of the inositol hexaphosphate, comprising inositol pentaphosphate, inositol tetraphosphate, inositol triphosphate, inositol diphosphate, inositol monophosphate, and salts or esters thereof, in any ratio. ### Claim 3 (depends on 1) The method for preparing the high-purity sugammadex sodium according to claim 1, wherein a mass ratio of the protective agent to the crude sugammadex sodium is 0.001% or above. ### Claim 4 (depends on 3) The method for preparing the high-purity sugammadex sodium according to claim 3, wherein the mass ratio of the protective agent to the crude sugammadex sodium is 0.1%-1%. ### Claim 5 (depends on 1) The method for preparing the high-purity sugammadex sodium according to claim 1, wherein a solvent for the recrystallization is selected from a combination of water and a poor solvent for sugammadex sodium. ### Claim 6 (depends on 5) The method for preparing the high-purity sugammadex sodium according to claim 5, wherein the solvent for the recrystallization is selected from the combination of water and the poor solvent for sugammadex sodium, and the poor solvent for sugammadex sodium is one solvent or a mixture of more than one solvent selected from the group consisting of methanol, ethanol, acetonitrile, acetone, and N,N-dimethylformamide. ### Claim 7 (depends on 6) The method for preparing the high-purity sugammadex sodium according to claim 6, wherein the method comprises the following specific process steps: dissolving the crude sugammadex sodium in water, adding the protective agent, increasing a temperature under the protection of the inert gas, then adding the poor solvent for sugammadex sodium, then performing stirring to decrease the temperature to −20° C. to 30° C., and performing a filtration to obtain the pure sugammadex sodium. ### Claim 8 (depends on 1) The method for preparing the high-purity sugammadex sodium according to claim 1, wherein the inert gas is selected from the group consisting of nitrogen, argon, helium, and carbon dioxide. ### Claim 9 (depends on 2) The method for preparing the high-purity sugammadex sodium according to claim 2, wherein a solvent for the recrystallization is selected from a combination of water and a poor solvent for sugammadex sodium, and the poor solvent for sugammadex sodium is one solvent or a mixture of more than one solvent selected from the group consisting of methanol, ethanol, acetonitrile, acetone, and N,N-dimethylformamide. ### Claim 10 (depends on 3) The method for preparing the high-purity sugammadex sodium according to claim 3, wherein a solvent for the recrystallization is selected from a combination of water and a poor solvent for sugammadex sodium, and the poor solvent for sugammadex sodium is one solvent or a mixture of more than one solvent selected from the group consisting of methanol, ethanol, acetonitrile, acetone, and N,N-dimethylformamide. ### Claim 11 (depends on 4) The method for preparing the high-purity sugammadex sodium according to claim 4, wherein a solvent for the recrystallization is selected from a combination of water and a poor solvent for sugammadex sodium, and the poor solvent for sugammadex sodium is one solvent or a mixture of more than one solvent selected from the group consisting of methanol, ethanol, acetonitrile, acetone, and N,N-dimethylformamide.