# US 2019/0167583 A1 · Oral cannabinoid formulations

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2019/0167583 A1
- Document ID: US20190167583A1
- Status: Published application
- Kind: A1
- Application number: 16/314,569
- Filed: 2017-06-29
- Published: 2019-06-06
- Earliest claimed: 2016-07-01
- Assignees: GW Research Limited
- Applicants: GW Research Limited
- Inventors: Harshit Shah
- Web page: https://patentgrep.com/patent/US20190167583A1

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- 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 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- 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)
- A61P 25/08: Antiepileptics; Anticonvulsants
- 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 invention relates to a cannabinoid containing oral solution. Preferably the oral solution comprises a cannabinoid, a lipid solvent, a sweetener and ethanol, characterised in that the sweetener is an ultrahigh potency sweetener.

## Claims

### Claim at position 1

-17. (canceled)

### Claim 18

An oral solution comprising:
a cannabinoid;
a lipid solvent;
an ultrahigh potency sweetener; and
ethanol.

### Claim 19 (depends on 18)

The solution of claim 18, wherein the ultrahigh potency sweetener has a sweetness intensity compared to sucrose of greater than 1000.

### Claim 20 (depends on 18)

The solution of claim 18, wherein the ultrahigh potency sweetener has a sweetness intensity compared to sucrose of greater than 5000.

### Claim 21 (depends on 18)

The solution of claim 18, wherein the ultrahigh potency sweetener is (N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester) (Neotame).

### Claim 22 (depends on 18)

The solution of claim 18, wherein the ultrahigh potency sweetener is N-[n-3-(3-hydroxy-4methoxyphenyl)propyl-α-L-aspartyl]-L-phenylalanine 1-methyl ester) (Advantame).

### Claim 23 (depends on 18)

The solution of claim 18, further comprising a flavourant.

### Claim 24 (depends on 18)

The solution of claim 18, wherein the cannabinoid is 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 25 (depends on 18)

The solution of claim 18, wherein the cannabinoid is cannabidiol (CBD).

### Claim 26 (depends on 1)

The solution of claim 1, wherein the cannabinoid is present in an amount of from 5 to 40% (w/v), ethanol is present in an amount of less than 2% (w/v), ultrahigh potency sweetener is present in less than 0.05% (w/v), flavourant is present in an amount of less 0.2% (w/v) and lipid solvent is q.s. to 100%.

### Claim 27 (depends on 26)

The solution of claim 26, wherein the cannabinoid is CBD, the ultrahigh potency sweetener is Neotame, the flavourant is strawberry flavour and the lipid solvent is sesame oil.

### Claim 28 (depends on 18)

The solution of claim 18, wherein the formulation is stable in climatic zones I and II for up to 24 months at 25° C.

### Claim 29 (depends on 18)

The solution of claim 18, wherein the formulation is stable in climatic zones III and IV for up to 18 months at 30° C.

### Claim 30 (depends on 18)

The solution of claim 18, wherein the solution lacks a stabilizing agent.

### Claim 31 (depends on 18)

A method of treating a subject comprising administering the solution of claim 18 to the subject.

### Claim 32 (depends on 31)

The method of claim 31, wherein the subject is a human.

### Claim 33 (depends on 31)

The method of claim 31, wherein the subject has epilepsy or one or more syndromes associated therewith.

### Claim 34 (depends on 33)

The method of claim 33, wherein the epilepsy or one or more syndromes associated therewith are selected from Dravet Syndrome, Lennox Gastaut Syndrome, myocolonic seizures, juvenile mycolonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, tuberous sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's Disease, and autism.

### Claim 35 (depends on 18)

A method of treating a condition in a subject having the condition, comprising administering the solution of claim 18 to the subject, wherein the condition is selected from Dravet Syndrome, Lennox Gastaut Syndrome, myocolonic seizures, juvenile mycolonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, tuberous sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's Disease, and autism.