# US 10,307,392 B2 · Compound and method for treatment of diseases and disorders

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

- Number: US 10,307,392 B2
- Document ID: US10307392B2
- Status: Granted
- Kind: B2
- Application number: 15/789,998
- Filed: 2017-10-21
- Published: 2019-04-25
- Granted: 2019-06-04
- Earliest claimed: 2017-10-21
- Applicants: Alexander Kariman
- Inventors: Alexander Kariman
- Web page: https://patentgrep.com/patent/US10307392B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 36/3482: {Cannabis}
- A61P 37/00: Drugs for immunological or allergic disorders
- 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 disclosed invention generally relates to treatment and/or prevention of symptoms associated with cannabinoid responsive diseases and disorders in subjects in need thereof, as well as the method of administering therapeutically-effective amount of a pharmaceutical compound containing cannabinoids. The disclosed invention further relates to pharmaceutical compounds for treating and/or preventing symptoms associated with said diseases and disorders.

## Claims

### Claim 1

A method of treating with reduced adverse psychotropic effect pain, inflammation, mood and motor symptoms associated with psychiatric, autoimmune and neurological diseases and disorders in a subject manifesting one or more of said symptoms,
the method comprising administering to a subject 0.3 mg or more of a pharmaceutical compound one or more times in 24 hours, comprising of an extract of a Cannabis plant and at least one pharmacologically inactive substance; and
where said extract contains one or more tetrahydrocannabinol (THC) isomers and one or more cannabidiol (CBD) isomers in the ratio of 1 (THC) and 2 (CBD) by mass; and
where said CBD augments the pharmacodynamics of THC in a subject; and
where said compound contains one or more non-cannabinoid components consisting of one or more of the following: terpenes; sterols; triglycerides; alkanes; squalene; tocopherol; carotenoids; chlorophyll; flavonoid; glycosides and alkaloids.

### Claim 2 (depends on 1)

The method of claim 1, where said extract contains one or more tetrahydrocannabinol (THC) isomers and one or more cannabidiol (CBD) isomers in the ratio of 0.5 to 1 (THC) and 1.5 to 2 (CBD) by mass.

### Claim 3 (depends on 1)

The method of claim 1, where said extract contains one or more tetrahydrocannabinol (THC) isomers and one or more cannabidiol (CBD) isomers in the ratio of 1 to 1.8 (THC) and 2 to 2.5 (CBD) by mass.

### Claim 4 (depends on 1)

The method of claim 1, where said compound contains one or more other cannabinoids.

### Claim 5 (depends on 1)

The method of claim 1, where said compound is administered in a sustained release, or extended release, or a combined sustained release, or extended release fraction dosage form, or in an immediate release dosage form, or a combined sustained release fraction and immediate release fraction dosage form, or a combination thereof.

### Claim 6 (depends on 1)

The method of claim 1, where said compound is administered by a route selected from the group consisting of: oral, intranasal, inhalation, parenteral, transdermal, rectal, vaginal, buccal, and sublingual, or combination thereof.

### Claim 7 (depends on 1)

The method of claim 1, where said compound is administered in a dosage form selected from the group consisting of: a tablet, a hard gelatin capsule, a soft gelatin capsule, a non-gelatin capsule, an HPMC capsule, an inhalant, an injectable, a transdermal, a buccal, a sublingual, and a rectal or a vaginal suppository.

### Claim 8 (depends on 1)

The method of claim 1, where said treatment involves obtaining from the subject at least once in 72 hours at least some vital signs parameters.

### Claim 9 (depends on 1)

The method of claim 1, where said compound is administered in combination with one or more other medications.

### Claim 10 (depends on 1)

The method of claim 1, where said compound is administered for treating symptoms associated with diseases or disorders selected from the group consisting of: autoimmune diseases and disorders, motor neuron diseases and disorders, neurodegenerative diseases and disorders, pain associated with cancer and trauma.

### Claim 11 (depends on 1)

The method of claim 1, where said tetrahydrocannabinol (THC) or said cannabidiol (CBD) is one or more of: (i) natural cannabinoids that have been purified or modified; (ii) synthetically derived cannabinoids; (iii) semi-synthetic cannabinoids; (iv) esterified cannabinoids; (v) active metabolites of any of the foregoing, (vi) pro-drugs of any of the foregoing; and (vii) mixtures thereof.

### Claim 12 (depends on 1)

The method of claim 1, where said compound is a liquid solution or liquid suspension.

### Claim 13 (depends on 1)

The method of claim 1, where said compound is administered for treating spasticity symptoms associated with multiple sclerosis disease or other neurodegenerative diseases.

### Claim 14

A pharmaceutical compound for treating with reduced adverse psychotropic effect pain, inflammation, mood and motor symptoms associated with psychiatric, autoimmune and neurological diseases and disorders in a subject manifesting one or more of said symptoms, comprising of an extract of Cannabis sativa plant and at least one pharmacologically inactive substance; and
where said extract contains one or more tetrahydrocannabinol (THC) isomers and one or more cannabidiol (CBD) isomers in the ratio of 1 (THC) and 2 (CBD) by mass; and
where said CBD augments the pharmacodynamics of THC in a subject; and
where said compound contains one or more non-cannabinoid components consisting of one or more of the following: terpenes; sterols; triglycerides; alkanes; squalene; tocopherol; carotenoids; chlorophyll; flavonoid; glycosides and alkaloids.

### Claim 15 (depends on 14)

The compound of claim 14, where said extract contains one or more tetrahydrocannabinol (THC) isomers and one or more cannabidiol (CBD) isomers in the ratio of 0.5 to 1 (THC) and 1.5 to 2 (CBD) by mass.

### Claim 16 (depends on 14)

The compound of claim 14, where said extract contains one or more tetrahydrocannabinol (THC) isomers and one or more cannabidiol (CBD) isomers in the ratio of 1 to 1.8 (THC) and 2 to 2.5 (CBD) by mass.

### Claim 17 (depends on 14)

The compound of claim 14, where said compound contains one or more other cannabinoids, at least one of the following: cannabigerol (CBG), Cannabichromene (CBC), cannabinol (CBN), cannabielsoin (CBE), iso-tetrahydrocannabimol (iso-THC), cannabicyclol (CBL), cannabicitran (CBT), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV) and cannabigerol monomethyl ether (CBGM), or any combination thereof, or a natural or synthetic analogue thereof, and/or derivatives thereof.

### Claim 18 (depends on 14)

The compound of claim 14, where said extract of Cannabis sativa is obtained by supercritical or subcritical extraction with CO2 or purified using chromatographic techniques.

### Claim 19 (depends on 14)

The compound of claim 14, where said compound is packaged in a dosage form selected from the group consisting of: a tablet, a hard gelatin capsule, a soft gelatin capsule, a non-gelatin capsule, an HPMC capsule, an inhalant, a parenteral, a transdermal, a sublingual, a rectal, a vaginal, and a suppository.

### Claim 20 (depends on 14)

The compound of claim 14, where said pharmacologically inactive substance contains at least some sesame oil, or its derivative, or pharmaceutically acceptable fixed oil.

### Claim 21 (depends on 14)

The compound of claim 14, where said compound contains one or more other medications.

### Claim 22 (depends on 14)

The compound of claim 14, where said compound is used for treating symptoms associated with diseases or disorders selected from the group consisting of: autoimmune diseases and disorders, motor neuron diseases and disorders, neurodegenerative diseases and disorders, pain associated with cancer and trauma.

### Claim 23 (depends on 14)

The compound of claim 14, where said tetrahydrocannabinol (THC) or said cannabidiol (CBD) is one or more of: (i) natural cannabinoids that have been purified or modified; (ii) synthetically derived cannabinoids; (iii) semi-synthetic cannabinoids; (iv) esterified cannabinoids; (v) active metabolites of any of the foregoing, (vi) pro-drugs of any of the foregoing; and (vii) mixtures thereof.

### Claim 24 (depends on 14)

The compound of claim 14, where said compound is a liquid solution or liquid suspension.

### Claim 25 (depends on 14)

The compound of claim 14, where the initial purity of said tetrahydrocannabinol (THC) or said cannabidiol (CBD) by HPLC is at least 98% by area and the stability is such that at least 95% by area remains in undegraded form after exposure of the compound to the storage conditions for at least twelve months, where the ambient temperature is between 20° C. and 40° C. and relative humidity is between 55% and 75%.

### Claim 26 (depends on 14)

The compound of claim 14, where said compound is used for treating spasticity symptoms.

### Claim 27

A pharmaceutical compound for treating with reduced adverse psychotropic effect pain, inflammation, mood and motor symptoms associated with psychiatric, autoimmune and neurological diseases and disorders in a subject manifesting one or more of said symptoms, comprising of an extract of one or more Cannabis species plants and at least one pharmacologically inactive substance; and where said compound is packaged in a soft gelatin capsule, where said capsule does not contain lambda-carrageenan, kappa-carrageenan, iota-carrageenan and any mixture of the carrageenans.
