# US 10,479,842 B2 · Treating mucosal lesions with hyaluronan delivered from an adhering troche

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- Number: US 10,479,842 B2
- Document ID: US10479842B2
- Status: Granted
- Kind: B2
- Application number: 15/607,366
- Filed: 2017-05-26
- Published: 2017-10-19
- Granted: 2019-11-19
- Earliest claimed: 2013-10-16
- Assignees: Quest Products, LLC
- Applicants: Quest Products, LLC
- Inventors: Jeffrey Haley
- Web page: https://patentgrep.com/patent/US10479842B2

## CPC

- C08B 37/0072: {Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin}
- A61K 9/2086: {Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat (active cores with a complete drug-free outer coat A61K9/28)}
- A61K 31/728: Hyaluronic acid
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- C08L 5/08: Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
- C08B: POLYSACCHARIDES; DERIVATIVES THEREOF (polysaccharides containing less than six saccharide radicals attached to each other by glycosidic linkages C07H; fermentation or enzyme-using processes C12P19/00; sugar industry C13; production of cellulose D21)
- 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
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

A troche comprising at least 5 mg hyaluronan, wherein the troche is adherent, and wherein hyaluronan is released from the troche, is used to treat mucositis, including stomatitis, vestibulitis, aphthous ulcerations, lichen planus and Behcet's syndrome. A method for treating or preventing mucositis in a patient is provided, comprising applying to a mucosal surface or a tooth or orthodontic brace of a patient in need thereof an adhering troche comprising at least 5 mg hyaluronan.

## Claims

### Claim 1

A bilayer troche comprising from 5 mg to less than 250 mg hyaluronan, wherein the troche has a pressed powder adherent layer and a pressed powder non-adherent layer, wherein the non-adherent layer comprises 2 to 50% hyaluronan by weight of the non-adherent layer and a lubricating substance, and wherein, when held in a human mouth, hyaluronan is released from the troche, thereby treating mucositis.

### Claim 2 (depends on 1)

The troche of claim 1, wherein the troche comprises 10 mg to less than 250 mg hyaluronan.

### Claim 3 (depends on 1)

The troche of claim 1, wherein the troche comprises at least 2% hyaluronan.

### Claim 4 (depends on 1)

The troche of claim 1, wherein the hyaluronan has an average molecular weight of at least 500,000 daltons.

### Claim 5 (depends on 1)

The troche of claim 1, wherein the hyaluronan has an average molecular weight of at least 1,500,000 daltons.

### Claim 6 (depends on 1)

A method for treating mucositis in a patient comprising:
applying the bilayer troche of claim 1 to a mucosal surface or a tooth or orthodontic brace of a patient in need thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the hyaluronan has an average molecular weight of at least 500,000 daltons.

### Claim 8 (depends on 6)

The method of claim 6, wherein the hyaluronan has an average molecular weight of at least 1,500,000 daltons.

### Claim 9 (depends on 6)

The method of claim 6, wherein the adhering troche is applied just before sleeping.

### Claim 10 (depends on 6)

The method of claim 6, wherein the adhering troche is applied at least once a day every day for prevention.

### Claim 11 (depends on 6)

The method of claim 6, wherein the mucositis is stomatitis or aphthous ulcers.

### Claim 12 (depends on 6)

The method of claim 6, wherein the mucositis occurs in an oro-pharynx or an oesophagus.

### Claim 13 (depends on 6)

The method of claim 6, wherein the mucositis occurs in a vagina, vulva, or rectum.

### Claim 14 (depends on 1)

The bilayer troche of claim 1, wherein the troche further comprises one or more vitamins.

### Claim 15 (depends on 1)

The bilayer troche of claim 1, wherein the troche has a water activity lower than 0.8.

### Claim 16 (depends on 1)

The bilayer troche of claim 1, wherein the non-adherent layer further comprises 20 to 70% acacia gum and 2 to 50% cellulose gum as a binder.