# US 10,245,274 B2 · Chitosan-based matrices and uses thereof

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- Number: US 10,245,274 B2
- Document ID: US10245274B2
- Status: Granted
- Kind: B2
- Application number: 15/167,136
- Filed: 2016-05-27
- Published: 2016-09-22
- Granted: 2019-04-02
- Earliest claimed: 2007-12-10
- Assignees: The Trustees of the University of Pennsylvania
- Applicants: The Trustees of the University of Pennsylvania
- Inventors: Bert W. O'Malley; Daqing Li; David Paulson
- Web page: https://patentgrep.com/patent/US10245274B2

## CPC

- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0046: {Ear}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- 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

This invention relates a controlled release delivery composition for an otorhinolaryngology and otorhinolaryngology-associated pathology, conditions, indications or their combination, Head and Neck associated pathology conditions, indications or their combination, or their combination, using a chitosan-glycerophosphate (CGP) hydrogel and an agent or a bio-materials. Additionally, provided methods of treating an otorhinolaryngology and otorhinolaryngology-associated pathology, conditions, indications or their combination, Head and Neck associated pathology conditions, indications or their combination, or their combination.

## Claims

### Claim 1

A method of treating an otorhinolaryngology-associated pathology, or Head and Neck associated pathology in a subject, comprising administering through the auditory bulla a composition onto the round window membrane of the subject for release of an agent to the perilymph of the inner ear of the subject, wherein said composition comprises a solution of chitosan-glycerophosphate (CGP) and the agent, wherein the agent dissolved therein is present in an amount effective in the treatment of the otorhinolaryngology-associated pathology, or Head and Neck associated pathology, wherein auditory functions are preserved by said administering.

### Claim 2 (depends on 1)

The method of claim 1, whereby said composition comprises 2-10% (w/w) chitosan.

### Claim 3 (depends on 1)

The method of claim 1, whereby said composition comprises 5-30% (w/w) glycerophosphate.

### Claim 4 (depends on 1)

The method of claim 1, whereby said composition is a controlled release composition.

### Claim 5 (depends on 4)

The method of claim 4, whereby said composition releases said agent over a period of no less than 24 hours.

### Claim 6 (depends on 4)

The method of claim 4, whereby a release profile is adjusted by varying a ratio of chitosan to glycerophosphate macromonomers.

### Claim 7 (depends on 6)

The method of claim 6, whereby, when the agent is hydrophilic, the higher the ratio of chitosan to glycerophosphate macromonomers, the longer is the agent release following the initial release.

### Claim 8 (depends on 6)

The method of claim 6, whereby, when the agent is hydrophobic, the lower the ratio of chitosan to glycerophosphate macromonomers, the, longer is the agent release following the initial release.

### Claim 9 (depends on 1)

The method of claim 1, whereby the Otorhinolaryngology-associated pathology includes the diseases of otology, neurotology, rhinology, allergy, laryngology, bronchoesophagology, head and neck.

### Claim 10 (depends on 1)

The method of claim 1, wherein the agent is Dexamethasone.

### Claim 11 (depends on 4)

The method of claim 4, wherein the agent is released to the subject for one to four days.

### Claim 12 (depends on 1)

The method of claim 1, wherein the pathology is vertigo.

### Claim 13 (depends on 1)

The method of claim 1, wherein the pathology is Ménière's disease.