# US 10,765,658 B2 · Oral compositions delivering therapeutically effective amounts of cannabinoids

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- Number: US 10,765,658 B2
- Document ID: US10765658B2
- Status: Granted
- Kind: B2
- Application number: 15/615,521
- Filed: 2017-06-06
- Published: 2017-12-28
- Granted: 2020-09-08
- Earliest claimed: 2016-06-22
- Assignees: Mastix LLC
- Applicants: MastiX, LLC
- Inventors: Robert Estey; William O. Brisben
- Web page: https://patentgrep.com/patent/US10765658B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/0058: {Chewing gums (non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00)}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2095: {Tabletting processes}
- A61K 31/70: Carbohydrates; Sugars; Derivatives thereof (sorbitol A61K31/047)
- A61K 36/3482: {Cannabis}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/06: Antimigraine 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

Oral compositions provide delivery of cannabinoids to a subject. The oral compare chewable, fast- or slow-dissolving once placed in the mouth of a subject.

## Claims

### Claim 1

A composition consisting of:
about 0.1% to about 20% by weight hemp oil extract,
about 35% to about 80% by weight of a sugar alcohol, or a blend of sugar alcohols,
about 1% to about 20% by weight of flavoring,
about 0.1% to about 10% by weight of tableting lubricants and powder flow agents,
about 0.01% to about 2% by weight of intensive sweeteners, and
about 5% to about 25% of a gum base,
based on the total weight of the composition.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the hemp oil extract comprises a cannabidiol (CBD), of about 0.1% to about 80% by weight, based on total weight of the hemp oil extract.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the sugar alcohol or sugar alcohol blend comprise: sorbitol, isomalt, xylitol, maltitol, mannitol, erythritol or combinations thereof.

### Claim 4

A composition for treating a disease or disorder associated with abnormal mitogen-activated protein (MAP) kinase activity or levels wherein the composition comprises hemp oil, sugar alcohol, a blend of sugar alcohols, a gum base, or combinations thereof, wherein the composition, based on the total weight of the composition, comprises:
about 0.1% to about 20% by weight hemp oil extract,
about 35% to about 80% by weight of a sugar alcohol, or a blend of sugar alcohols, and
about 5% to about 25% of a gum base.

### Claim 5 (depends on 4)

The composition of claim 4, wherein a disease or disorder associated with abnormal mitogen-activated protein (MAP) kinase activity or levels comprises: migraines, neuropathic pain, general pain, joint pain or combinations thereof.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the tableting lubricants and powder flow agents comprise magnesium stearate, silicon dioxide, calcium stearate, stearic acid, talc, rice bran-based excipients, or combinations thereof.

### Claim 7

A method of treating a disease or disorder associated with abnormal or increased mitogen-activated protein (MAP) kinase activity or levels in a subject, comprising: administering to a subject in need thereof, a gum-based composition for chewing, the composition consisting of:
about 0.1% to about 20% by weight hemp oil extract,
about 35% to about 80% by weight of a sugar alcohol, or a blend of sugar alcohols,
about 1% to about 20% by weight of flavoring,
about 0.1% to about 10% by weight of tableting lubricants and powder flow agents,
about 0.01% to about 2% by weight of intensive sweeteners, and
about 5% to about 25% of a gum base,
based on the total weight of the composition,
wherein the disease or disorder associated with abnormal or increased mitogen-activated protein (MAP) kinase activity or levels in the subject is selected from the group consisting of a neuroinflammatory disease or disorder, migraines, epilepsy, neuropathic pain, general pain, joint pain, head trauma, or combinations thereof.

### Claim 8 (depends on 7)

The method of claim 7, wherein the hemp oil extract comprises a cannabidiol (CBD), of about 0.1% to about 80% by weight, based on total weight of the hemp oil extract.

### Claim 9 (depends on 7)

The method of claim 7, wherein the sugar alcohol or sugar alcohol blend comprises:
sorbitol, isomalt, xylitol, maltitol, mannitol, erythritol or combinations thereof.

### Claim 10 (depends on 7)

The method of claim 7, wherein the tableting lubricants and powder flow agents comprise magnesium stearate, silicon dioxide, calcium stearate, stearic acid, talc, rice bran-based excipients, or combinations thereof.
