# US 2023/0056488 A1 · Composition, article and method for affecting a mammal

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- Number: US 2023/0056488 A1
- Document ID: US20230056488A1
- Status: Published application
- Kind: A1
- Application number: 17/971,462
- Filed: 2022-10-21
- Published: 2023-02-23
- Earliest claimed: 2020-04-21
- Assignees: Coolhouse Sourcing LLC
- Applicants: Coolhouse Sourcing LLC
- Inventors: Lee Wayne MAYBERRY; Matthew David SCARLETT; Max RUNKE
- Web page: https://patentgrep.com/patent/US20230056488A1

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- 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 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/10: Sulfides; Sulfoxides; Sulfones
- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 36/258: Panax (ginseng)
- A61K 36/324: Boswellia, e.g. frankincense
- A61K 36/3482: {Cannabis}
- A61K 36/81: Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K 36/9066: Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- 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
- 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 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61P 25/00: Drugs for disorders of the nervous system
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Compositions, articles and methods for treating sleeplessness, anxiety, pain or inflammation include: (i) one or more pharmacologically active, non-psychoactive cannabinoids; (ii) one or more active agents; and an optional carrier or matrix. The optional carrier or matrix may comprise ingredients such as solvents, solid or dissolvable supports, fillers, flavorants, flavor or taste masking agents, and other adjuvants that provide the composition in a useful form factor configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients.

## Claims

### Claim 1

A composition for treating sleeplessness, anxiety, pain or inflammation in a mammal, the composition comprising as active ingredients:
(i) one or more pharmacologically active, non-psychoactive cannabinoids; and
(ii) one or more non-prescription, non-cannabinoid active agents selected from the following subclasses:
a) amino acid-based ingredients having central nervous system effects;
b) receptor modulators for acetylcholinesterase, butyrylcholinesterase, 5-HT1 or 5-HT2; and
c) extracts or ground portions (other than such receptor modulators) of a medicinal plant, tree bark or roots; and
an optional carrier or matrix in which the active ingredients are dissolved or dispersed.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the disclosed is in the form of an article comprising a carrier or matrix in which active ingredients (a) and (b) are dispersed.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition contains the carrier or matrix and the carrier or matrix comprises a solvent, dispersing liquid, dissolvable support, solid support, filler, flavorant, flavor or taste masking agent, and other adjuvants that provide the composition in a useful form factor configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the composition contains a non-prescription, non-cannabinoid active agent from each of subclasses a), b) and c).

### Claim 5 (depends on 4)

The composition of claim 4, further comprising a nonprescription active agent from the following subclass:
d) monoamine metabolizers.

### Claim 6 (depends on 4)

The composition of claim 4, wherein the composition contains the carrier or matrix and the carrier or matrix comprises a solvent, dispersing liquid, dissolvable support, solid support, filler, flavorant, flavor or taste masking agent, and other adjuvants that provide the composition in a useful form factor configured for easy administration to a mammal of an appropriate pharmacological dosage of the active ingredients.

### Claim 7 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of prescription drugs.

### Claim 8 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of over-the-counter cold remedies.

### Claim 9 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of over-the-counter allergy treatments.

### Claim 10 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of stimulants.

### Claim 11 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of psychoactive cannabinoids.

### Claim 12 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of antagonists for the amino acid-based ingredients present in the composition.

### Claim 13 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of antagonists for the receptor modulators present in the composition.

### Claim 14 (depends on 4)

The composition of claim 4, wherein the composition is substantially free of antagonists for the extracts of a medicinal plant, tree bark or root present in the composition.

### Claim 15 (depends on 4)

The composition of claim 4, wherein the composition contain no more than three active agents that adversely interact with or inhibit another active agent in the composition and thereby reduce its effectiveness in addressing sleeplessness, anxiety or anxiousness, pain or inflammation.

### Claim 16 (depends on 4)

The composition of claim 4, wherein the composition contain no more than two active agents that adversely interact with or inhibit another active agent in the composition and thereby reduce its effectiveness in addressing sleeplessness, anxiety or anxiousness, pain or inflammation.

### Claim 17 (depends on 4)

The composition of claim 4, wherein the composition contain no more than one active agent that adversely interacts with or inhibits another active agent in the composition and thereby reduces its effectiveness in addressing sleeplessness, anxiety or anxiousness, pain or inflammation.

### Claim 18 (depends on 4)

The composition of claim 4, wherein the composition contain no active agents that adversely interact with or inhibit another active agent in the composition and thereby reduce its effectiveness in addressing sleeplessness, anxiety or anxiousness, pain or inflammation.

### Claim 19 (depends on 4)

The composition of claim 4, wherein the composition is in the form of an article comprising a carrier or matrix in which active ingredients (i) and (ii) are dispersed.

### Claim 20

A method for treating sleeplessness in a mammal, the method comprising the step of administering to such mammal a composition comprising as active ingredients:
(i) one or more pharmacologically active, non-psychoactive cannabinoids; and
(ii) a pharmacologically active, non-prescription, non-cannabinoid active agent from each of the following subclasses:
a) amino acid-based ingredients having central nervous system effects;
b) receptor modulators for acetylcholinesterase, butyrylcholinesterase, 5-HT1 or 5-HT2; and
c) extracts or ground portions (other than such receptor modulators) of a medicinal plant, tree bark or roots; and
(iii) a carrier or matrix in which active ingredients (i) and (ii) are dispersed.

### Claim 21

A method for treating anxiety in a mammal, the method comprising the step of administering to such mammal a composition comprising as active ingredients:
(i) one or more pharmacologically active, non-psychoactive cannabinoids; and
(ii) a pharmacologically active, non-prescription, non-cannabinoid active agent from each of the following subclasses:
a) amino acid-based ingredients having central nervous system effects;
b) receptor modulators for acetylcholinesterase, butyrylcholinesterase, 5-HT1 or 5-HT2; and
c) extracts or ground portions (other than such receptor modulators) of a medicinal plant, tree bark or roots; and
(iii) a carrier or matrix in which active ingredients (i) and (ii) are dispersed.

### Claim 22

A method for treating pain or inflammation in a mammal, the method comprising the step of administering to such mammal a composition comprising as active ingredients:
(i) one or more pharmacologically active, non-psychoactive cannabinoids; and
(ii) a pharmacologically active, non-prescription, non-cannabinoid active agent from each of the following subclasses:
a) amino acid-based ingredients having central nervous system effects;
b) receptor modulators for acetylcholinesterase, butyrylcholinesterase, 5-HT1 or 5-HT2; and
c) extracts or ground portions (other than such receptor modulators) of a medicinal plant, tree bark or roots; and
(iii) a carrier or matrix in which active ingredients (i) and (ii) are dispersed.