# US 2024/0197771 A1 · Compositions and uses thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2024/0197771 A1 - Document ID: US20240197771A1 - Status: Published application - Kind: A1 - Application number: 18/569,597 - Filed: 2022-06-17 - Published: 2024-06-20 - Earliest claimed: 2021-06-17 - Inventors: Harshita PANT; Angel LOPEZ; Mark SCHEMBRI - Web page: https://patentgrep.com/patent/US20240197771A1 ## CPC - A61K 31/728: Hyaluronic acid - A61K 9/0043: {Nose} - A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)} - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61P 11/02: Nasal agents, e.g. decongestants - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - 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 disclosure relates generally to a topical composition comprising a therapeutically effective combination of (i) cromoglycic acid, or a pharmaceutically acceptable salt thereof, and (ii) hyaluronic acid, or a pharmaceutically-acceptable salt thereof (HA), which is suitable for nasal administration for the treatment of inflammation and wounds. ## Claims ### Claim 1 A topical composition comprising a therapeutically effective combination of (i) cromoglycic acid, or a pharmaceutically-acceptable salt thereof, and (ii) hyaluronic acid, or a pharmaceutically-acceptable salt thereof (HA). ### Claim 2 (depends on 1) The composition of claim 1, wherein the cromoglycic acid, or the pharmaceutically-acceptable salt thereof, is present in an amount of from about 0.5% to about 10% (w/v). ### Claim 3 (depends on 2) The composition of claim 2, wherein the cromoglycic acid, or the pharmaceutically-acceptable salt thereof, is present in an amount of from about 1% to about 5% (w/v). ### Claim 4 (depends on 2) The composition of claim 2, wherein the cromoglycic acid, or the pharmaceutically-acceptable salt thereof, is present in an amount of from about 3% to about 5% (w/v). ### Claim 5 (depends on 2) The composition of claim 2, wherein the cromoglycic acid, or the pharmaceutically-acceptable salt thereof, is present in an amount of from about 4% (w/v). ### Claim 6 (depends on 1, 2, 3, 4, 5) The composition of any one of claims 1 to 5, wherein the pharmaceutically-acceptable salt of cromoglycic acid is sodium cromoglycate. ### Claim 7 (depends on 1, 2, 3, 4, 5, 6) The composition of any one of claims 1 to 6, wherein the HA has an average molecular weight of from about 5 kDa to about 20,000 kDa. ### Claim 8 (depends on 7) The composition of claim 7, wherein the HA has an average molecular weight of from about 50 kDa to about 8,000 kDa. ### Claim 9 (depends on 7) The composition of claim 7, wherein the HA has an average molecular weight of from about 1000 kDa to about 8,000 kDa. ### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9) The composition of any one of claims 1 to 9, wherein the HA has a viscosity of from about 1,000 mPa/s to about 200,000 mPa/s. ### Claim 11 (depends on 10) The composition of claim 10, wherein the HA has a viscosity of from about 10,000 mPa/s to about 200,000 mPa/s. ### Claim 12 (depends on 10) The composition of claim 10, wherein the HA has a viscosity of from about 100,000 mPa/s to about 200,000 mPa/s. ### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) The composition of any one of claims 1 to 12, wherein the HA comprises cross-linked hyaluronans. ### Claim 14 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) The composition of any one of claims 1 to 13, wherein the HA is a water-insoluble gel. ### Claim 15 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14) The composition of any one of claims 1 to 14, wherein the composition is formulated for intra-operative administration. ### Claim 16 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15) The composition of any one of claims 1 to 15, wherein the composition is an intranasal composition. ### Claim 17 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16) A device configured for the delivery of the composition of any one of claims 1 to 16. ### Claim 18 (depends on 17) The device of claim 17, for the intranasal delivery of the composition. ### Claim 19 (depends on 17, 18) The device of claim 17 or claim 18, wherein the device is an intranasal device. ### Claim 20 (depends on 17, 18, 19) The device of any one of claims 17 to 19, wherein the device is a stent. ### Claim 21 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20) The device of any one of claims 17 to 20, wherein the device comprises the composition of any one of claims 1 to 15. ### Claim 22 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21) The composition of any one of claims 1 to 16 or the device of any one of claims 17 to 21, wherein the composition is formulated, and the device is configured, for co-administration with an additional therapeutic agent. ### Claim 23 The composition or device of 22, wherein the additional therapeutic agent is selected from the group consisting of a steroid, an antibiotic and an antimicrobial peptide (AMP) or a fusion protein comprising same. ### Claim 24 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21) A method of treating a condition associated with inflammation, the method comprising administering to a subject in need thereof the composition of any one of claims 1 to 16 or the device of any one of claims 17 to 21. ### Claim 25 (depends on 24) The method of claim 24, wherein the condition is associated with inflammation of the nasal mucosa. ### Claim 26 (depends on 25) The method of claim 25, wherein the condition is associated with inflammation of the sinonasal mucosa. ### Claim 27 (depends on 25, 26) The method of claim 25 or claim 26, wherein the condition is chronic rhinosinusitis (CRS). ### Claim 28 (depends on 27) The method of claim 27, wherein the CRS is chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP). ### Claim 29 (depends on 28) The method of claim 28, wherein the CRS is chronic rhinosinusitis with nasal polyps (CRSwNP). ### Claim 30 (depends on 29) The method of claim 29, wherein the composition or device is administered intraoperatively following endoscopic sinus surgery. ### Claim 31 (depends on 25, 26, 27, 28, 29, 30) The method of any one of claims 25 to 30, wherein the composition or device reduces inflammation of the nasal mucosa as determined by Lund Kennedy Sinus Endoscopy Score when compared to a composition or device comprising the HA in the absence of the cromoglycic acid, or the pharmaceutically-acceptable salt thereof. ### Claim 32 (depends on 31) The method of claim 31, wherein the reduction in inflammation of the nasal mucosa, as determined by Lund Kennedy Sinus Endoscopy Score, is evident by at least about 20 days following administration of the composition or device. ### Claim 33 (depends on 31) The method of claim 31, wherein the reduction in inflammation of the nasal mucosa, as determined by Lund Kennedy Sinus Endoscopy Score, is evident by at least about 40 days following administration of the composition or device. ### Claim 34 (depends on 31, 32, 33) The method of any one of claims 31 to 33, wherein the reduction in inflammation of the nasal mucosa, as determined by Lund Kennedy Sinus Endoscopy Score, persists for at least about 60 days following administration of the composition or device. ### Claim 35 (depends on 34) The method of claim 34, wherein the reduction in inflammation of the nasal mucosa, as determined by Lund Kennedy Sinus Endoscopy Score, persists for at least about 80 days following administration of the composition or device. ### Claim 36 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21) A method of promoting wound healing, the method comprising administering to a subject in need thereof the composition of any one of claims 1 to 16 or the device of any one of claims 17 to 21. ### Claim 37 (depends on 36) The method of claim 36 for promoting wound healing of the nasal mucosa. ### Claim 38 (depends on 37) The method of claim 37, wherein the wound is a post-operative lesion of the sinonasal mucosa following endoscopic sinus surgery. ### Claim 39 (depends on 37, 38) The method of claim 37 or claim 38, wherein the composition or device is administered intraoperatively following endoscopic sinus surgery. ### Claim 40 (depends on 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39) The method of any one of claims 24 to 39, comprising administering the composition or device intranasally to the subject. ### Claim 41 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21) The composition of any one of claims 1 to 16 or the device of any one of claims 17 to 21 for use in treating a condition associated with inflammation in a subject in need thereof. ### Claim 42 (depends on 41) The composition or the device for use of claim 41 for treating a condition associated with inflammation of the nasal mucosa. ### Claim 43 (depends on 41, 42) The composition or the device for use of claim 41 or claim 42, wherein the composition or device is formulated for intranasal administration to the subject in need thereof. ### Claim 44 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21) The composition of any one of claims 1 to 16 or the device of any one of claims 17 to 21 for use in promoting wound healing in a subject in need thereof. ### Claim 45 (depends on 44) The composition or the device for use of claim 44, wherein the wound is a wound of the nasal mucosa. ### Claim 46 (depends on 44, 45) The composition or the device for use of claim 44 or claim 45, wherein the composition is formulated, and the device is configured, for intranasal administration to the subject in need thereof. ### Claim 47 Use of a therapeutically effective combination of (i) cromoglycic acid, or a pharmaceutically-acceptable salt thereof, and (ii) hyaluronic acid, or a pharmaceutically-acceptable salt thereof (HA) in the manufacture of a medicament for treating a condition associated with inflammation in a subject in need thereof. ### Claim 48 (depends on 47) The use of claim 47, wherein the condition associated with inflammation is a condition associated with inflammation of the nasal mucosa. ### Claim 49 (depends on 47, 48) The use of claim 47 or claim 48, wherein the medicament is formulated for intranasal administration to the subject in need thereof. ### Claim 50 (depends on 47, 48, 49) The use of any one of claims 47 to 49, wherein the condition is associated with inflammation of the sinonasal mucosa. ### Claim 51 (depends on 50) The use of claim 50, wherein the condition is chronic rhinosinusitis (CRS). ### Claim 52 (depends on 51) The use of claim 51, wherein the CRS is chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP). ### Claim 53 (depends on 52) The use of claim 52, wherein the CRS is chronic rhinosinusitis with nasal polyps (CRSwNP). ### Claim 54 (depends on 47, 48, 49, 50, 51, 52, 53) The use of any one of claims 47 to 53, wherein the composition is formulated for administration intraoperatively following endoscopic sinus surgery. ### Claim 55 Use of a therapeutically effective combination of (i) cromoglycic acid, or a pharmaceutically-acceptable salt thereof, and (ii) hyaluronic acid, or a pharmaceutically-acceptable salt thereof (HA) in the manufacture of a medicament for promoting wound healing in a subject in need thereof. ### Claim 56 (depends on 55) The use of claim 55, wherein the wound is a wound of the nasal mucosa. ### Claim 57 (depends on 55, 56) The use of claim 55 or claim 56, wherein the medicament is formulated for intranasal administration to the subject in need thereof.