# US 11,896,569 B2 · Compositions comprising amino acids for use in the treatment of mucositides in neoplasia patients undergoing radiation therapy and/or chemotherapy

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- Number: US 11,896,569 B2
- Document ID: US11896569B2
- Status: Granted
- Kind: B2
- Application number: 17/515,155
- Filed: 2021-10-29
- Published: 2022-02-17
- Granted: 2024-02-13
- Earliest claimed: 2015-05-14
- Assignees: Professional Dietetics S.R.L.
- Applicants: Professional Dietetics S.p.A.
- Inventors: Paolo Luca Maria Giorgetti
- Web page: https://patentgrep.com/patent/US11896569B2

## 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 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/4172: Imidazole-alkanecarboxylic acids, e.g. histidine
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/51: Thiamines, e.g. vitamin B1
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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

Amino acid composition for use in the treatment of mucositis in patients suffering from head and neck cancer, undergoing radiation therapy and/or chemotherapy, the composition comprising an active agent, the active agent comprising the amino acids: glutamine, leucine, isoleucine, valine, lysine, threonine, histidine, phenylalanine, methionine, tryptophan, tyrosine, and cystine, wherein the glutamine:leucine weight ratio is in the range 4.3 to 5.3.

## Claims

### Claim 1

A method of treating mucositis in a patient who is suffering from neoplasia of the cervical-cephalic region and who is undergoing radiation therapy and/or chemoradiotherapy, the method consists of:
(1) selecting an amino acid composition for use in the treatment of mucositis in the patient who is suffering from neoplasia of the cervical-cephalic region and who is undergoing radiation therapy and/or chemoradiotherapy, the amino acid composition consists of:
(i) an active agent, said active agent consists of the amino acids glutamine, leucine, isoleucine, valine, lysine, threonine, histidine, phenylalanine, methionine, tryptophan, tyrosine, and cystine, wherein
(a) the amino acid composition is free of any further different amino acids,
(b) the glutamine:leucine weight ratio is in the range 4.3 to 5.3, and
(c) glutamine is present in an amount between 50 and 65% by weight with respect to the total weight of the active agent, and
(ii) optionally at least one of, none of which have any amino acids: carbohydrates, at least one thickening agent, at least one vitamin, pharmaceutically acceptable excipients, and flavouring substances, and
(2) administering the amino acid composition to the patient to treat mucositis in the patient who is suffering from neoplasia of the cervical-cephalic region and who is undergoing radiation therapy and/or chemoradiotherapy.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the leucine:isoleucine:valine weight ratio is equivalent to 2:1:1.

### Claim 3 (depends on 1)

The method according to claim 1, wherein
the isoleucine:leucine weight ratio is in the range 0.2-0.7, and/or
the valine:leucine weight ratio range is in the range 0.2-0.8.

### Claim 4 (depends on 1)

The method according to claim 1, wherein
the threonine:leucine weight ratio is in the range 0.15-0.50, and/or
the lysine:leucine weight ratio is in the range 0.15-0.60.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the at least one thickening agent is selected from the group consisting of xanthan gum, cellulose and derivatives thereof, konjak gum, konjak glucomannan, Arabic gum, modified starches.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the at least one vitamin is selected from vitamin B1, vitamin B6, vitamin C.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the glutamine is present in an amount between 55 and 60% by weight with respect to the total weight of the active agent.

### Claim 8 (depends on 3)

The method according to claim 3, wherein the isoleucine:leucine weight ratio is between 0.4-0.6.

### Claim 9 (depends on 3)

The method according to claim 3, wherein the valine:leucine weight ratio range is between 0.4-0.7.

### Claim 10 (depends on 4)

The method according to claim 4, wherein the threonine:leucine weight ratio is between 0.20-0.45.

### Claim 11 (depends on 4)

The method according to claim 4, wherein the lysine:leucine weight ratio is between 0.30-0.55.