# US 2021/0330797 A1 · Stable cannabinoid formulations

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- Number: US 2021/0330797 A1
- Document ID: US20210330797A1
- Status: Published application
- Kind: A1
- Application number: 17/367,876
- Filed: 2021-07-06
- Published: 2021-10-28
- Earliest claimed: 2014-05-29
- Assignees: Radius Pharmaceuticals, Inc.
- Applicants: Radius Pharmaceuticals, Inc.
- Inventors: Kiran Kumar Vangara; Huaguang Li; Ningxin Yan; Hung Q. Nguyen; Venkat R. Goskonda
- Web page: https://patentgrep.com/patent/US20210330797A1

## CPC

- 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)
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- 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 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/22: Anxiolytics
- A61P 25/30: for treating abuse or dependence
- A61P 25/34: Tobacco-abuse
- A61P 25/36: Opioid-abuse
- A61P 35/00: Antineoplastic agents
- 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 is generally directed to substantially pure cannabidiol, stable cannabinoid pharmaceutical formulations, and methods of their use.

## Claims

### Claim at position 1

1-27. (canceled)

### Claim 28

An oral composition consisting of:
10 to 17% w/w cannabidiol (CBD);
60 to 85% w/w sesame oil;
5 to 15% w/w ethanol;
a sweetener;
a flavoring agent, and
optionally a preservative,
wherein the CBD has a purity of greater than 98% w/w, and wherein the composition is a liquid composition for oral administration.

### Claim 29 (depends on 28)

The composition of claim 28, comprising about 10% w/w CBD.

### Claim 30 (depends on 28)

The composition of claim 28, comprising about 80% w/w of sesame oil.

### Claim 31 (depends on 28)

The composition of claim 28, wherein the sweetener is sucralose.

### Claim 32 (depends on 28)

The composition of claim 28, comprising about 0.1 to about 2% w/w of sweetener.

### Claim 33 (depends on 28)

The composition of claim 28, wherein the flavoring agent is strawberry flavor.

### Claim 34 (depends on 28)

The composition of claim 28, comprising about 0.01 to about 1% w/w of flavoring agent.

### Claim 35 (depends on 28)

The composition of claim 28, comprising about 0.30% w/w of flavoring agent.

### Claim 36 (depends on 28)

The composition of claim 28, wherein the preservative is benzyl alcohol.

### Claim 37 (depends on 28)

The composition of claim 28 wherein the pH of the formulation is from about 6 to about 7.

### Claim 38 (depends on 28)

A method for treating a disease or disorder, or a symptom of a disease or disorder, comprising administering the composition of claim 28 to a patient in need thereof, wherein the disease or disorder is selected from the group consisting of Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, and tubular sclerosis complex.

### Claim 39 (depends on 38)

The method of claim 38, wherein the disease or disorder is Dravet Syndrome.

### Claim 40 (depends on 38)

The method of claim 38, wherein the disease or disorder is Lennox Gastaut Syndrome.

### Claim 41 (depends on 38)

The method of claim 38, wherein the disease or disorder is tubular sclerosis complex.

### Claim 42 (depends on 38)

The method of claim 38, wherein the disease or disorder is infantile spasms and/or West Syndrome.

### Claim 43 (depends on 38)

The method of claim 38, wherein the disease or disorder involves myoclonic seizures.