# US 11,998,632 B2 · Oral cannabinoid compositions and methods for treating neuropathic pain

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- Number: US 11,998,632 B2
- Document ID: US11998632B2
- Status: Granted
- Kind: B2
- Application number: 17/012,366
- Filed: 2020-09-04
- Published: 2021-03-11
- Granted: 2024-06-04
- Earliest claimed: 2019-09-05
- Assignees: Avicanna Inc.
- Applicants: Avicanna Inc.
- Inventors: Frantz Henri Emmanuel Le Devedec; Aras Azadian; Setu Nimish Purohit; Justin Michael Grant; Samantha Carolyn Watt
- Web page: https://patentgrep.com/patent/US11998632B2

## CPC

- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 9/4858: {Organic compounds}
- A61K 9/4866: {Organic macromolecular compounds}
- 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 47/26: 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

Self-emulsifying drug delivery systems are provided for oral delivery of cannabinoids. The cannabinoids are dissolved in an oily medium (e.g. medium chain triglycerides) together with at least one surfactant to improve dissolution, stability, and bioavailability. Also provided are methods comprising uses of an oral cannabinoid compositions for the treatment of neuropathic pain in a subject.

## Claims

### Claim 1

A self-emulsifying oral composition comprising a cannabinoid consisting of cannabidiol (CBD) at 0.01-10% (w/w), polysorbate 80 at 40-50% (w/w), medium chain triglycerides (MCI) extracted from coconut oil at 15-25% (w/w), and polyethylene glycol (PEG) 2000, PEG 5000, PEG 10000 or PEG 20000 at 25-35% (w/w), wherein the said composition forms an in-situ oil-in-water emulsion upon contact with aqueous media.

### Claim 2 (depends on 1)

The oral cannabinoid composition of claim 1, wherein the composition is an emulsion pre-concentrate.

### Claim 3 (depends on 2)

The oral cannabinoid composition of claim 2, wherein the emulsion pre-concentrate is filled into single unit dosage forms selected from self-emulsifying capsules, drinking ampoules, dose cushions, or any other suitable dosage forms selected from powder, granules, pellets, chewable soft pills and chewy-base lozenges.

### Claim 4 (depends on 3)

The oral cannabinoid composition of claim 3, wherein the composition is a self-emulsifying capsule.

### Claim 5

The oral cannabinoid composition of 1, wherein the composition is formulated to achieve in-vivo peak plasma levels in the range of 900 to 1100 ng/ml at 1 hour.

### Claim 6 (depends on 1)

A method of treating a neuropathic pain condition in a subject caused by alcoholism; amputation; cancer; carpal tunnel syndrome; chemotherapy; diabetes; facial nerve problems; HIV infection/AIDS; multiple myeloma; multiple sclerosis; nerve or spinal cord compression from herniated discs or from arthritis in the spine; shingles; spine surgery; syphilis; thyroid problems or vitamin B deficiency comprising administering to the subject an oral composition of claim 1.

### Claim 7 (depends on 1)

The composition of claim 1 comprising a cannabinoid consisting of cannabidiol (CBD) at about 5% (w/w), polysorbate 80 at about 45% (w/w), medium chain triglycerides (MCT) extracted from coconut oil at about 20% (w/w), and a polyethylene glycol (PEG) 2000, PEG 5000, PEG 10000 or PEG 20000 at about 30% (w/w), wherein the said composition forms in-situ oil-in-water emulsion upon contact with aqueous media.