# US 12,109,251 B2 · Satiation peptide administration

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- Number: US 12,109,251 B2
- Document ID: US12109251B2
- Status: Granted
- Kind: B2
- Application number: 17/366,825
- Filed: 2021-07-02
- Published: 2021-12-30
- Granted: 2024-10-08
- Earliest claimed: 2009-01-21
- Assignees: University of Florida Research Foundation, Inc.
- Applicants: University of Florida Research Foundation, Incorporated
- Inventors: Sergei Zolotukhin; Andres Acosta
- Web page: https://patentgrep.com/patent/US12109251B2

## CPC

- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- 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 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/0058: {Chewing gums (non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00)}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 48/005: {characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered}
- A61K 48/0075: {characterised by an aspect of the delivery route, e.g. oral, subcutaneous}
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- C07K 14/575: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin C07K14/665, e.g. corticotropin C07K14/695)
- C12N 2799/025: where the vector is derived from a parvovirus
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Disclosed herein are compositions and methods for treating obesity involving satiation gut peptide administration to the mouth of a subject for a predetermined dose and frequency. In other embodiments, materials and methods of treating certain psychological disorders are disclosed involving satiation gut peptides. In exemplary embodiments, the satiation gut peptide pertains to PYY.

## Claims

### Claim 1

A dissolvable solid or semi-solid pharmaceutical composition comprising Peptide YY (PYY) and a pharmaceutically acceptable carrier in a unit dosage form,
wherein the unit dosage form provides no substantial change to the concentration of PYY in the plasma after the delivery, wherein the unit dosage form is configured to contact the tongue of the subject for at least 5 seconds.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the unit dosage form is a lozenge comprising a dissolvable planar sheet, or solid or semi-solid candy.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition consists essentially of PYY in a unit dosage form.

### Claim 4 (depends on 3)

The pharmaceutical composition of claim 3, wherein the unit dosage form is a lozenge comprising a dissolvable planar sheet, or solid or semi-solid candy.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1, wherein the PYY comprises the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition consists essentially of PYY comprising the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2.

### Claim 7

A dissolvable solid or semi-solid pharmaceutical composition comprising a satiation gut peptide and a pharmaceutically acceptable carrier in a unit dosage form, wherein the satiation gut peptide is selected from the group consisting of PYY, Glucagon-like Peptide-1, Oxyntomodulin, and Cholecystokinin,
wherein the unit dosage form provides no substantial change to the concentration of the satiation gut peptide in the plasma after the delivery, wherein the unit dosage form is configured to contact the tongue of the subject for at least 5 seconds.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein the unit dosage form is a lozenge comprising a dissolvable planar sheet, or solid or semi-solid candy.

### Claim 9

A dissolvable solid or semi-solid pharmaceutical composition comprising satiation gut peptides and a pharmaceutically acceptable carrier in a unit dosage form, wherein the satiation gut peptides are selected from the group consisting of PYY, Glucagon-like Peptide-1, Oxyntomodulin, and Cholecystokinin,
wherein the unit dosage form provides no substantial change to the concentration of the satiation gut peptides in the plasma after the delivery, wherein the unit dosage form is configured to contact the tongue of the subject for at least 5 seconds.
