# US 11,077,193 B2 · Nerve growth factor composition and powder injection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,193 B2 - Document ID: US11077193B2 - Status: Granted - Kind: B2 - Application number: 15/568,455 - Filed: 2016-04-18 - Published: 2018-06-14 - Granted: 2021-08-03 - Earliest claimed: 2015-04-21 - Assignees: Staidson (Beijing) Biopharmaceuticals Co., Ltd.; Beijing Staidson Medical Technology Co., Ltd. - Applicants: Staidson (Beijing) Biopharmaceuticals Co., Ltd.; Beijing Staidson Medical Technology Co., Ltd. - Inventors: Jianping Tan; Bingzhang Wang - Web page: https://patentgrep.com/patent/US11077193B2 ## CPC - 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 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 38/18: Growth factors; Growth regulators - A61K 38/185: {Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3} - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61P 25/00: Drugs for disorders of the nervous system - 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 The present invention discloses nerve growth factor composition and an injection powder comprising the following components: 10 μg/mL-100 μg/mL of a nerve growth factor; 10 mg/mL-80 mg/mL of disaccharide stabilizer; 0 mg/mL-30 mg/mL of an amino acid stabilizer; 0.01 mg/mL-1 mg/mL of surfactant, 10 mg/mL-50 mg/mL of a supporting agent; a pH buffer for maintaining the nerve growth factor composition at 6.0-7.4, and solvent being water. The nerve growth factor composition and the injection powder can avoid the potential risk resulting from the virus of other unknown components carried in albumin by using a disaccharide or a combination of a disaccharide and an amino acid instead of albumin as a stabilizer; not only have protective effect on mNGF, but also can ensure the stability of hNGF and rhNGF in the preparation, transportation and storage processes, and have better medication safety and quality control. ## Claims ### Claim 1 An albumin-free nerve growth factor composition, wherein the albumin-free nerve growth factor composition comprises the following components: a nerve growth factor at a mass-volume concentration of 50 μg/mL; a disaccharide stabilizer at a mass-volume concentration of 30 mg/mL; an amino acid stabilizer, including at least one of isoleucine and glutamic acid, at a mass-volume concentration of 10 mg/mL; a surfactant at a mass-volume concentration of 0.5 mg/mL; a supporting agent, including mannitol, dextrin, or dextran, at a mass-volume concentration of 20 mg/mL; a pH buffer for maintaining the albumin-free nerve growth factor composition at a pH value of 6.0 to 7.4, wherein a mole concentration of the pH buffer is 20 mM; and a solvent, wherein the solvent is water. ### Claim 2 (depends on 1) The albumin-free nerve growth factor composition according to claim 1, wherein the disaccharide stabilizer is at least one of maltose, trehalose, sucrose, and lactose. ### Claim 3 (depends on 1) The albumin-free nerve growth factor composition according to claim 1, wherein the amino acid stabilizer further includes at least one of alanine, glycine, arginine, and histidine. ### Claim 4 (depends on 3) The albumin-free nerve growth factor composition according to claim 3, wherein the amino acid stabilizer further includes histidine and arginine in a ratio of 12:13. ### Claim 5 (depends on 1) The albumin-free nerve growth factor composition according to claim 1, wherein the disaccharide stabilizer and the amino acid stabilizer are any one of the following groups: lactose, sucrose, and isoleucine; and maltose, alanine, arginine, and glutamic acid. ### Claim 6 (depends on 1) The albumin-free nerve growth factor composition according to claim 1, wherein the surfactant is a nonionic surfactant. ### Claim 7 (depends on 1) A method for preparation of an albumin-free nerve growth factor composition injection powder, wherein the albumin-free nerve growth factor composition according to claim 1 is lyophilized to obtain the albumin-free nerve growth factor composition injection powder. ### Claim 8 (depends on 7) An albumin-free nerve growth factor composition injection powder prepared by the method according to claim 7. ### Claim 9 (depends on 1) The albumin-free nerve growth factor composition according to claim 1, wherein a water content is 2.0-2.8%. ### Claim 10 An albumin-free nerve growth factor composition, wherein the albumin-free nerve growth factor composition comprises the following components: a mass-volume concentration of a nerve growth factor is 50 μg/mL; a mass-volume concentration of a disaccharide stabilizer is 30 mg/mL; a mass-volume concentration of an amino acid stabilizer is 3 mg/mL; a mass-volume concentration of a surfactant is 0.2 mg/mL; a mass-volume concentration of a supporting agent is 50 mg/mL; and a mole concentration of a pH buffer is 25 mM. ### Claim 11 An albumin-free nerve growth factor composition, wherein the albumin-free nerve growth factor composition comprises the following components: a mass-volume concentration of a nerve growth factor is 50 μg/mL; a mass-volume concentration of a disaccharide stabilizer is 30 mg/mL; a mass-volume concentration of an amino acid stabilizer is 10 mg/mL; a mass-volume concentration of a surfactant is 0.5 mg/mL; a mass-volume concentration of a supporting agent is 20 mg/mL; and a mole concentration of a pH buffer is 20 mM. ### Claim 12 An albumin-free nerve growth factor composition, wherein the albumin-free nerve growth factor composition comprises the following components: a mass-volume concentration of a nerve growth factor is 60 μg/mL; a mass-volume concentration of a disaccharide stabilizer is 40 mg/mL; a mass-volume concentration of an amino acid stabilizer is 4 mg/mL; a mass-volume concentration of a surfactant is 0.1 mg/mL; a mass-volume concentration of a supporting agent is 30 mg/mL; and a mole concentration of a pH buffer is 25 mM.