# US 11,110,073 B2 · Storage stable aqueous injectable solution comprising diclofenac > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,073 B2 - Document ID: US11110073B2 - Status: Granted - Kind: B2 - Application number: 15/933,937 - Filed: 2018-03-23 - Published: 2018-09-27 - Granted: 2021-09-07 - Earliest claimed: 2017-03-24 - Assignees: Cadila Healthcare Limited - Applicants: Cadila Healthcare Limited - Inventors: Sushilkumar Dhanaji Patil; Nirav Ishwarlal Khatri; Alex Kochukunju George; Sushrut Krishnaji Kulkarni - Web page: https://patentgrep.com/patent/US11110073B2 ## CPC - A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil - 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 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - 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 present invention relates to a stable, aqueous, injectable solution comprising diclofenac and polyvinylpyrrolidone. The present invention also relates to processes for preparing the injectable solution. ## Claims ### Claim 1 An aqueous solution for parenteral administration comprising diclofenac sodium, polysorbate 80 and polyvinylpyrrolidone, wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C. ### Claim 2 (depends on 1) The aqueous solution according to claim 1, wherein the diclofenac sodium is present in a concentration of about 75 mg/mL. ### Claim 3 (depends on 1) The aqueous solution according to claim 1, wherein the diclofenac sodium is present in a concentration of about 37.5 mg/mL. ### Claim 4 (depends on 1) The aqueous solution according to claim 1, wherein the diclofenac sodium is present in a concentration of about 25 mg/mL. ### Claim 5 (depends on 1) The aqueous solution according to claim 1, wherein the polyvinylpyrrolidone is present in a concentration of about 160 mg/mL. ### Claim 6 (depends on 1) The aqueous solution according to claim 1, wherein the polyvinylpyrrolidone is present in a concentration of about 80 mg/mL. ### Claim 7 (depends on 1) The aqueous solution according to claim 1, wherein the polyvinylpyrrolidone is present in a concentration of about 70 mg/mL. ### Claim 8 (depends on 1) The aqueous solution according to claim 1 further comprising one or more antioxidants and/or one or more pH adjusting agents. ### Claim 9 (depends on 8) The aqueous solution according to claim 8, wherein the antioxidant is monothioglycerol. ### Claim 10 (depends on 9) The aqueous solution according to claim 9, wherein the monothioglycerol is present in a concentration of about 5 mg/mL. ### Claim 11 (depends on 1) The aqueous solution according to claim 1, wherein the polysorbate 80 is present in a concentration between about 5 mg/mL and about 20 mg/mL. ### Claim 12 (depends on 8) The aqueous solution according to claim 8, wherein the pH adjusting agent is sodium hydroxide and/or hydrochloric acid. ### Claim 13 (depends on 1) The aqueous solution according to claim 1, wherein the solution has a viscosity between about 1.5 cP and about 7.5 cP. ### Claim 14 (depends on 1) The aqueous solution according to claim 1, wherein the solution has a transmittance value of not less than 90%. ### Claim 15 (depends on 1) The aqueous solution according to claim 1, wherein the solution has an absorbance value of not more than 1. ### Claim 16 A stable aqueous solution for parenteral administration comprising diclofenac sodium, polysorbate 80 and polyvinylpyrrolidone, wherein the solution does not contain impurity A (1-(2,6-dichlorophenyl) indolin-2-one) more than 0.3% by weight of diclofenac, as measured by HPLC, wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C. ### Claim 17 A storage stable aqueous solution for parenteral administration comprising diclofenac sodium, polysorbate 80, and polyvinylpyrrolidone, wherein the solution retains at least 95% of the diclofenac after storage for 3 months at 25° C. and 60% relative humidity, and wherein the solution has a pH between about 7 and about 10. ### Claim 18 An aqueous solution for parenteral administration consisting of diclofenac sodium, polyvinylpyrrolidone, polysorbate 80, sodium chloride, one or more pH adjusting agents, water, optionally one or more preservatives, optionally one or more antioxidants and optionally one or more buffering agents, wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C. ### Claim 19 A method for treatment of pain by administering an aqueous solution via parenteral route, wherein the solution comprises diclofenac sodium, polyvinylpyrrolidone and polysorbate 80 wherein the solution has a pH between about 7 and about 10, and wherein the solution remains clear after 6 months of storage at 25° C.