# US 11,896,587 B2 · Tryptamine compositions for enhancing neurite outgrowth

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- Number: US 11,896,587 B2
- Document ID: US11896587B2
- Status: Granted
- Kind: B2
- Application number: 17/308,869
- Filed: 2021-05-05
- Published: 2021-08-19
- Granted: 2024-02-13
- Earliest claimed: 2016-07-23
- Assignees: Turtle Bear Holdings, LLC
- Applicants: Turtle Bear Holdings, LLC
- Inventors: Paul Edward Stamets
- Web page: https://patentgrep.com/patent/US11896587B2

## CPC

- A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61K 31/407: condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
- A61K 36/07: Basidiomycota, e.g. Cryptococcus
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 2236/00: Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- 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

Described herein are neurotrophic and nootropic compositions and methods for treating subjects with such compositions. In one aspect the composition comprises one or more tryptamines or in pure form or extracts from psilocybin containing mushrooms, or combinations thereof optionally combined with one or more phenethylamines or amphetamines in pure form or extracts from a plant or mushroom, or combinations thereof, optionally one or more erinacines or hericenones in pure form, extracts from Hericium mushroom species (e.g., H. erinaceus, H. coralloides, H. ramosum) or combinations thereof, optionally one or more cannabinoids in pure form or extracts from Cannabis sativa, Cannabis sativa, Cannabis indica, or Cannabis ruderalis, optionally, one or more adversive compounds, and optionally one or more pharmaceutically acceptable excipients.

## Claims

### Claim 1

A method of treating or reducing symptoms of a mood disorder in a subject in need thereof, the method comprising:
administering to the subject a pharmaceutical dosage form comprising:
1 mg to 10 mg of psilocybin or psilocin; and
one or more pharmaceutically acceptable excipients,
1 to 6 times per day sufficient to treat or reduce the symptoms of the mood disorder in the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pharmaceutical dosage form comprises 1 mg, 2 mg, 3 mg, 4 mg, 5, mg, 6 mg, 7 mg, 8 mg, 9 mg, or 10 mg of psilocybin or psilocin.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pharmaceutical dosage form comprises psilocybin containing mushrooms or extracts thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pharmaceutical dosage form further comprises 10 μg to 200 mg of one or more adversives.

### Claim 5 (depends on 4)

The method of claim 4, wherein the one or more adversives comprises niacin, ipecac, apomorphine, bittering agents, denatonium benzoate, capsaicin, capsacutin, dihydrocapsaicin, nordihydrocapsaicin, homocapsaicin, homodihydrocapsaicin, capsaicinoids, gingerol, pipeline, isopiperine, zingerone, shogaol, vanillylamide derivatives, or combinations thereof.

### Claim 6 (depends on 4)

The method of claim 4, wherein the one or more adversives comprises niacin.

### Claim 7 (depends on 1)

The method of claim 1, wherein the pharmaceutical dosage form is a capsule comprising a powder admixture, liquid, suspension, or emulsion.

### Claim 8 (depends on 1)

The method of claim 1, wherein the pharmaceutically acceptable excipients comprise one or more fillers, binders, diluents, vehicles, lubricants, preservatives, flavors, colorants, or combinations thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein the mood disorder comprises depression, anxiety, major depressive disorder, treatment resistant depression, persistent depression, manic depression or bipolar disorder, depressive psychosis, perinatal depression, premenstrual dysphoric disorder, seasonal depression, situational depression, panic disorder, post-traumatic stress disorder, obsessive compulsive disorder, or substance abuse disorders.

### Claim 10

A method of treating or reducing symptoms of depression or anxiety in a subject in need thereof, the method comprising:
administering to the subject a pharmaceutical dosage form comprising:
1 mg to 10 mg of psilocybin or psilocin; and
one or more pharmaceutically acceptable excipients,
1 to 6 times per day sufficient to treat or reduce the symptoms of depression or anxiety in the subject.

### Claim 11 (depends on 10)

The method of claim 10, wherein the pharmaceutical dosage form comprises 1 mg, 2 mg, 3 mg, 4 mg, 5, mg, 6 mg, 7 mg, 8 mg, 9 mg, or 10 mg of psilocybin or psilocin.

### Claim 12 (depends on 10)

The method of claim 10, wherein the pharmaceutical dosage form comprises psilocybin containing mushrooms or extracts thereof.

### Claim 13 (depends on 10)

The method of claim 10, wherein the pharmaceutical dosage form further comprises 10 μg to 200 mg of one or more adversives.

### Claim 14 (depends on 13)

The method of claim 13, wherein the one or more adversives comprises niacin, ipecac, apomorphine, bittering agents, denatonium benzoate, capsaicin, capsacutin, dihydrocapsaicin, nordihydrocapsaicin, homocapsaicin, homodihydrocapsaicin, capsaicinoids, gingerol, pipeline, isopiperine, zingerone, shogaol, vanillylamide derivatives, or combinations thereof.

### Claim 15 (depends on 13)

The method of claim 13, wherein the one or more adversives comprises niacin.

### Claim 16 (depends on 10)

The method of claim 10, wherein the pharmaceutical dosage form is a capsule comprising a powder admixture, liquid, suspension, or emulsion.

### Claim 17 (depends on 10)

The method of claim 10, wherein the pharmaceutically acceptable excipients comprise one or more fillers, binders, diluents, vehicles, lubricants, preservatives, flavors, colorants, or combinations thereof.

### Claim 18 (depends on 10)

The method of claim 10, wherein the depression comprises major depressive disorder, treatment resistant depression, persistent depression, manic depression or bipolar disorder, depressive psychosis, perinatal depression, premenstrual dysphoric disorder, seasonal depression, or situational depression.
