# US 2019/0314296 A1 · Parenteral formulations > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0314296 A1 - Document ID: US20190314296A1 - Status: Published application - Kind: A1 - Application number: 16/314,583 - Filed: 2017-06-29 - Published: 2019-10-17 - Earliest claimed: 2016-07-01 - Assignees: GW Research Limited - Applicants: GW Research Limited - Inventors: Stephen Wright; Jitinder WILKHU - Web page: https://patentgrep.com/patent/US20190314296A1 ## CPC - A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol} - 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 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - 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: 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 parenteral cannabinoid formulations, and more particularly to cannabinoid containing intravenous (IV) formulations. Preferably the parenteral containing formulation comprises a cannabinoid; an isotonic agent; a surfactant; and one or more stability enhancers. Furthermore the cannabinoid may be selected from one or more of cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), cannabigerolpropyl variant (CBGV), cannabicyclol (CBL), cannabinol (CBN), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV) and tetrahydrocannabivarinic acid (THCVA). ## Claims ### Claim 1 An aqueous parenteral formulation comprising: (i) a cannabinoid; (ii) an isotonic agent; (iii) a surfactant; and (iv) one or more stability enhancers. ### Claim 2 (depends on 1) The formulation of claim 1 wherein the cannabinoid is selected from: cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), cannabigerol propyl variant (CBGV), cannabicyclol (CBL), cannabinol (CBN), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV) and tetrahydrocannabivarinic acid (THCVA). ### Claim 3 (depends on 1) The formulation of claim 1, wherein the cannabinoid is CBD or CBDV. ### Claim 4 (depends on 1) The formulation of claim 1, wherein the cannabinoid is present in an amount of 0.3 to 50 mg/ml. ### Claim 5 (canceled) ### Claim 6 (depends on 1) The formulation of claim 1, wherein the isotonic agent is selected from: polyethylene glycol, glycerol, saline and glucose. ### Claim 7 (depends on 1) The formulation of claim 1, wherein the formulation has an osmolality is in the range of from 100-500 mOsMol/Kg. ### Claim 8 (depends on 1) The formulation of claim 1, wherein the isotonic agent is glycerol, and wherein the glycerol is present in an amount of 5 to 50 mg/ml. ### Claim 9 (canceled) ### Claim 10 (depends on 1) Formulation of claim 1, wherein the surfactant is a non-ionic surfactant selected from Polyoxyethylene (20) sorbitan monooleate, Polysorbate 80; Macrogol 15 hydroxystearate and Polyoxamers. ### Claim 11 (depends on 10) The formulation of claim 10 wherein the surfactant is Macrogol 15 hydroxystearate, and the Macrogol 15 hydroxystearate is present in an amount of from 5 to 500 mg/ml. ### Claim 12 (canceled) ### Claim 13 (depends on 1) The formulation of claim 1 wherein the one or more stability enhancers comprises one or more antioxidants selected from ascorbic acid, monothioglycerol, cysteine HCl and Glutathione. ### Claim 14 (depends on 13) The formulation of claim 13 wherein the one or more stability enhancers is selected from ascorbic acid, monothioglycerol, and a combination thereof. ### Claim 15 (depends on 14) The formulation of claim 14 wherein when ascorbic acid is present, the ascorbic acid is present in an amount of from 0.5 to 10 mg/ml, and when monothioglycerol is present, the monothioglycerol is present in an amount of from 0.5 to 10 mg/ml. ### Claim at position 16 -19. (canceled) ### Claim 20 (depends on 1) The formulation of claim 1 wherein the one or more stability enhancers comprises a chelating agent selected from: disodium EDTA and calcium disodium EDTA. ### Claim 21 (depends on 20) The formulation of claim 20 wherein the chelating agent is calcium disodium EDTA, and is present in an amount of from 0.1 to 10 mg/ml. ### Claim at position 19 -29. (canceled) ### Claim 30 (depends on 1) A method of preparing the formulation of claim 1, comprising preparing a stock solution of a cannabinoid in a surfactant; preparing an aqueous solution comprising the isotonic agent and one or more stability enhancers; and slowly adding the aqueous solution to the stock solution of the cannabinoid in the surfactant. ### Claim 31 (depends on 30) The method of claim 30 wherein the cannabinoid is CBD or CBDV, the surfactant is macrogol 15 hydroxystearate, the isotonic agent is glycerol, and the stability enhancers are ascorbic acid, monothioglycerol and calcium disodium EDTA; and the method further comprises: generating a solution of CBD or CBDV in macrogol 15 hydroxystearate by heating the macrogol 15 hydroxystearate to about 40° C.; and adding the CBD or CBDV at about 60° C. to the macrogol 15 hydroxystearate; generating an aqueous solution by sparging the water with nitrogen; heating the water to about 60° C.; and adding the glycerol, monothioglycerol, EDTA and ascorbic acid to the water; and slowly adding to the solution of CBD in Macrogol 15 hydroxystearate to the aqueous solution. ### Claim at position 22 -35. (canceled) ### Claim 36 (depends on 1) A method of treating a subject comprising administering the aqueous parenteral formulation of claim 1 to the subject. ### Claim at position 24 -38. (canceled) ### Claim 39 (depends on 36) The method of claim 36, wherein the formulation is administered as a rescue formulation. ### Claim at position 26 -43. (canceled) ### Claim 44 (depends on 36) The method of claim 36, wherein the formulation is administered for the treatment of one or more conditions requiring the administration of a neuroprotectant or anti-convulsive medication. ### Claim 45 (depends on 44) The method of claim 44, wherein the one or more conditions are selected from newborn hypoxic-ischemic encephalopathy (NHIE), status epilepticus, and stroke. ### Claim at position 29 -47. (canceled)