# US 12,005,071 B2 · Injectable antibiotic formulations and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,071 B2 - Document ID: US12005071B2 - Status: Granted - Kind: B2 - Application number: 18/123,811 - Filed: 2023-03-20 - Published: 2023-07-20 - Granted: 2024-06-11 - Earliest claimed: 2015-06-10 - Assignees: Dechra Veterinary Products, LLC - Applicants: Dechra Veterinary Products, LLC - Inventors: Neil E. Paulsen; Gail L. Dempsey; Michael S. Daniel; Tiffany G. Tomlinson; Douglas I. Hepler; Raymond Petzold - Web page: https://patentgrep.com/patent/US12005071B2 ## CPC - A61K 31/7052: having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides - 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 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - 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) - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract Provided herein are pharmaceutically acceptable compositions containing macrolide antibiotics, in particular azithromycin. In particular, compositions containing azithromycin with low toxicity, especially for administration to felines, are provided herein. ## Claims ### Claim 1 A non-aqueous composition, comprising: (i) a macrolide; (ii) at least two solvents; and (iii) a surfactant; wherein a first solvent is triacetin, and wherein the triacetin is present in an amount of about 23 to 70% w/w, wherein a second solvent is selected from the group consisting of a triglyceride, acetylated monoglyceride, propyldicaprylates/dicaprates and caprylic/capric triglycerides, and wherein the second solvent is present in an amount of about 20-60%. ### Claim 2 (depends on 1) The composition of claim 1, wherein the macrolide is azithromycin. ### Claim 3 (depends on 1) The composition of claim 1, wherein the surfactant is selected from the group consisting of castor oil, hydrogenated castor oil, Polyoxyl 15 Hydroxystearate, polyethylene glycol 40 hydrogenated castor oil, propyl dicaprylate/dicaprate, D-α-tocopherol polyethylene glycol 1000 succinate (TPGS), polysorbate or lecithin. ### Claim 4 (depends on 3) The composition of claim 3, wherein the surfactant is Polyoxyl 15 Hydroxystearate. ### Claim 5 (depends on 2) The composition of claim 2, wherein azithromycin is present in an amount of about 7.0% w/w. ### Claim 6 (depends on 1) The composition of claim 1, wherein the composition is formulated for injection. ### Claim 7 (depends on 1) The composition of claim 1, wherein the second solvent is a triglyceride solvent. ### Claim 8 (depends on 7) The composition of claim 7, wherein the triglyceride solvent is caprylic or caprylic/capric triglycerides. ### Claim 9 (depends on 7) The composition of claim 7, wherein the triglyceride solvent is present in an amount of about 54.0% w/w. ### Claim 10 (depends on 8) The composition of claim 8, wherein the triglyceride solvent is a C8 triglyceride, a C10 triglyceride, or a mixture thereof. ### Claim 11 (depends on 1) The composition of claim 1, wherein the triacetin is present in an amount of about 38% w/w. ### Claim 12 (depends on 4) The composition of claim 4, wherein the Polyoxyl 15 Hydroxystearate is present in an amount of about 1% w/w. ### Claim 13 (depends on 1) The composition of claim 1, wherein the macrolide is a mono- or di-hydrate macrolide. ### Claim 14 (depends on 1) A method of treating an infection in a subject weighing less than about 100 pounds, comprising administering an effective amount of a composition of claim 1. ### Claim 15 (depends on 14) The method of claim 14, further comprising administering an additional antibiotic in combination with a non-aqueous composition comprising: (i) a macrolide; (ii) at least two solvents; and (iii) a surfactant; wherein a first solvent is triacetin, and wherein the triacetin is present in an amount of about 23 to 70% w/w, wherein a second solvent is selected from the group consisting of a triglyceride, acetylated monoglyceride, propyldicaprylates/dicaprates and caprylic/capric triglycerides, and wherein the second solvent is present in an amount of about 20-60%. ### Claim 16 (depends on 14) The method of claim 14, wherein the subject is a feline. ### Claim 17 (depends on 14) The method of claim 14, wherein the composition is administered by injection.