# US 10,117,938 B2 · Pharmaceutical formulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,117,938 B2 - Document ID: US10117938B2 - Status: Granted - Kind: B2 - Application number: 15/907,057 - Filed: 2018-02-27 - Published: 2018-07-05 - Granted: 2018-11-06 - Earliest claimed: 2015-01-21 - Assignees: Semnur Pharmaceuticals, Inc. - Applicants: Semnur Pharmaceuticals, Inc. - Inventors: Mahendra G. Shah - Web page: https://patentgrep.com/patent/US10117938B2 ## CPC - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - 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 9/0085: {Brain, e.g. brain implants; Spinal cord} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/02: Inorganic compounds - A61P 19/00: Drugs for skeletal disorders - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 19/04: for non-specific disorders of the connective tissue - A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents - A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease - A61P 25/04: Centrally acting analgesics, e.g. opioids - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - 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 Disclosed are aqueous pharmaceutical compositions which provide sustained released delivery of corticosteroid compounds. The pharmaceutical composition comprises a soluble corticosteroid and at least one viscosity enhancing agent. Also provided are methods for using the pharmaceutical compositions in an epidural injection, intra-articular injection, or an intra-lesional injection. ## Claims ### Claim 1 A method for treating inflammation and/or pain in an individual in need thereof, comprising: injecting an aqueous pharmaceutical composition into the epidural space of the individual, wherein the aqueous pharmaceutical composition comprises: a soluble corticosteroid selected from the group consisting of soluble salts and esters of dexamethasone, and at least one viscosity enhancing agent, wherein the at least one viscosity enhancing agent is sodium hyaluronate or hyaluronic acid, the molecular weight of the at least one viscosity enhancing agent is between 1.0 MDa and 2.5 MDa, and the concentration of the at least one viscosity enhancing agent is between 1.0% w/v and 1.5% w/v; and wherein the aqueous pharmaceutical composition is substantially free of insoluble corticosteroids. ### Claim 2 (depends on 1) The method of claim 1, wherein the soluble corticosteroid is dexamethasone sodium phosphate. ### Claim 3 (depends on 1) The method of claim 1, wherein the at least one viscosity enhancing agent is hyaluronic acid. ### Claim 4 (depends on 1) The method of claim 1, wherein the at least one viscosity enhancing agent is sodium hyaluronate. ### Claim 5 (depends on 1) The method of claim 1, wherein the molecular weight of the at least one viscosity enhancing agent is between 1.0 MDa and 2.0 MDa. ### Claim 6 (depends on 1) The method of claim 1, wherein the molecular weight of the at least one viscosity enhancing agent is between 1.2 MDa and 1.8 MDa. ### Claim 7 (depends on 1) The method of claim 1, wherein the soluble corticosteroid is dexamethasone sodium phosphate and the at least one viscosity enhancing agent is sodium hyaluronate, wherein the molecular weight of the sodium hyaluronate is between 1.0 MDa and 2.0 MDa, and the concentration of the sodium hyaluronate is about 1.25% w/v. ### Claim 8 (depends on 7) The method of claim 7, wherein the aqueous pharmaceutical composition comprises dexamethasone sodium phosphate at a concentration of about 6.58 mg/mL. ### Claim 9 (depends on 1) The method of claim 1, wherein the aqueous pharmaceutical composition comprises a soluble salt or ester of dexamethasone present at a weight equivalent to achieve a dexamethasone concentration of about 5 mg/mL. ### Claim 10 (depends on 1) The method of claim 1, wherein less than 27 N of force is used to inject the aqueous pharmaceutical composition into the epidural space. ### Claim 11 (depends on 1) The method of claim 1, wherein the aqueous pharmaceutical composition further comprises a preservative and/or an anesthetic. ### Claim 12 (depends on 1) The method of claim 1, wherein the individual has one or more of lower back pain, spinal stenosis, disc herniation, radiculitis or chronic discogenic pain. ### Claim 13 (depends on 1) The method of claim 1, wherein the individual has chronic discogenic pain. ### Claim 14 (depends on 1) The method of claim 1, wherein the individual has spondylolysis. ### Claim 15 (depends on 1) The method of claim 1, wherein the individual is injected with the aqueous pharmaceutical composition once every 1 to 12 weeks. ### Claim 16 (depends on 1) The method of claim 1, wherein the injecting is via an interlaminar injection. ### Claim 17 (depends on 1) The method of claim 1, wherein the injecting is via a caudal injection. ### Claim 18 (depends on 1) The method of claim 1, the injecting is via a transforaminal injection. ### Claim 19 (depends on 1) The method of claim 1, wherein the aqueous pharmaceutical composition has a viscosity of between 1 kcP and 10 kcP. ### Claim 20 (depends on 1) The method of claim 1, wherein the aqueous pharmaceutical composition has a viscosity of between 1 kcP and 5 kcP.