# US 11,998,519 B2 · Compositions and methods for prevention and reduction of traumatic brain injury

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- Number: US 11,998,519 B2
- Document ID: US11998519B2
- Status: Granted
- Kind: B2
- Application number: 17/696,723
- Filed: 2022-03-16
- Published: 2022-07-14
- Granted: 2024-06-04
- Earliest claimed: 2021-01-14
- Applicants: Rob D. Dickerman
- Inventors: Rob D. Dickerman
- Web page: https://patentgrep.com/patent/US11998519B2

## CPC

- 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 31/197: 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 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/4188: condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- 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

Compositions and methods are presented that, upon administration prior to trauma, are effective to prevent and/or reduce severity of sequelae of TBI upon trauma. Advantageously, the compositions presented herein can be orally administered, have an excellent safety profile, and will not require a prescription by physician or hospital admission.

## Claims

### Claim 1

A method of prophylactic neuroprotection that prevents or reduces at least one sequelae of traumatic brain injury (TBI), comprising:
orally administering to a subject about to engage in an activity selected from a contact sport, a motor sport, and a military engagement a composition that comprises a branched chain amino acids (BCAA) component and a vitamin component at least 10 minutes prior to participating in the activity;
wherein the BCAA component comprises leucine, valine, and isoleucine, and wherein the leucine, the valine, and the isoleucine are present in the BCAA component at a weight ratio of X:1:1, with X being between 2-4;
wherein the vitamin component comprises vitamin B7 and at least one vitamin selected from the group consisting of vitamin C, vitamin B3, vitamin B5, vitamin B6, vitamin B9, and vitamin B12; and
wherein the sequelae of TBI are selected from cognitive dysfunction, behavioral dysfunction, motor neural dysfunction, vestibular dysfunction, cerebral inflammation, and hyperglycemia.

### Claim 2 (depends on 1)

The method of claim 1, wherein the composition comprises at least three vitamins selected from said group.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition comprises the vitamin C, the vitamin B3, the vitamin B5, the vitamin B6, the vitamin B7, the vitamin B9, and the vitamin B12.

### Claim 4 (depends on 1)

The method of claim 1, wherein the BCAA component is present in the composition in an amount of 10,000 mg+/−10%.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition is formulated as a beverage, a snack bar, or a ready-to-use powder and wherein the composition optionally further comprises minerals, carbohydrates, and/or an herbal extract.

### Claim 6 (depends on 1)

The method of claim 1, wherein the composition is administered at least 15 minutes prior to participating in the activity.

### Claim 7 (depends on 1)

The method of claim 1, wherein the BCAA component is administered in an amount of between 4,400 mg and 10,000 mg.

### Claim 8 (depends on 1)

The method of claim 1, wherein the vitamin B7 component is administered in an amount of between 3-150 mg.

### Claim 9 (depends on 1)

The method of claim 1, further comprising orally administering at least one additional dosage unit of the composition upon the TBI.

### Claim 10 (depends on 1)

The method of claim 1, further comprising parenterally administering the composition upon the TBI.

### Claim 11 (depends on 1)

The method of claim 1, wherein the activity is a contact sport.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition comprises the vitamin C, the vitamin B3, the vitamin B5, the vitamin B6, the vitamin B7, the vitamin B9, and the vitamin B12.

### Claim 13 (depends on 1)

The method of claim 1, wherein the BCAA component is present in the composition in an amount of 10,000 mg+/−10%.

### Claim 14 (depends on 12)

The method of claim 12, wherein the BCAA component is present in the composition in an amount of 10,000 mg+/−10%.

### Claim 15 (depends on 13)

The method of claim 13, comprising orally administering said composition 10-40 minutes prior to participating in the activity.

### Claim 16 (depends on 14)

The method of claim 14, comprising orally administering said composition 10-40 minutes prior to participating in the activity.