# US 9,433,644 B2 · Formulations and methods for treating oral inflammation, injury, or pain

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- Number: US 9,433,644 B2
- Document ID: US9433644B2
- Status: Granted
- Kind: B2
- Application number: 14/340,447
- Filed: 2014-07-24
- Published: 2015-01-29
- Granted: 2016-09-06
- Earliest claimed: 2013-07-25
- Assignees: Rutgilli Pharmaceuticals, LLC
- Applicants: Invado Pharmaceuticals, LLC
- Inventors: Edward D. Kobus; Bartholomew Weldon
- Web page: https://patentgrep.com/patent/US9433644B2

## CPC

- A61K 33/42: Phosphorus; Compounds thereof
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A61K 47/02: Inorganic compounds
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/38: Cellulose; Derivatives thereof
- A61Q 11/00: Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
- 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)
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

The present invention generally relates to formulations and methods for treating oral inflammation, oral injury and/or oral pain by applying hydrogel, viscous liquid, or other formulation to the oral cavity. Wet formulations comprise a hydrophilic polymer selected from the group consisting of pyrrolidones, hyaluronic acid and salts thereof, alginic acid and salts thereof, and carrageenans and salts thereof; calcium salts or ions, phosphate salts or ions, and water as well as other optional components. Dry formulations such as powders are also contemplated.

## Claims

### Claim 1

A dry formulation adapted for reconstituting with water to form a liquid formulation for treating oral injury, oral inflammation and/or oral pain, the dry formulation comprising:
one or more hydrophilic polymers, at least one of which is selected from the group consisting of:
pyrrolidones,
hyaluronic acids and salts thereof;
alginic acids and salts thereof;
carrageenans and salts thereof;
celluloses;
dextrins;
and mixtures thereof, wherein said hydrophilic polymers are present in an amount between 4% to 85%, based on the total weight of the dry formulation;
from 2.5% to 7% by weight, based on the total weight of the dry formulation, of one or more calcium salts;
from 0.4% to 1.2% by weight, based on the total weight of the dry formulation, of one or more phosphate salts; and
sodium chloride.

### Claim 2 (depends on 1)

The dry formulation of claim 1, further comprising sodium bicarbonate.

### Claim 3 (depends on 1)

The dry formulation of claim 1, wherein at least one of said hydrophilic polymers includes a polyvinylpyrrolidone, sodium hyaluronate, a carrageenan, a microcrystalline cellulose and a maltodextrin.

### Claim 4 (depends on 1)

The dry formulation of claim 1, wherein at least one of said hydrophilic polymers is carrageenan or a salt thereof.

### Claim 5 (depends on 4)

The dry formulation of claim 4, further comprising a microcrystalline cellulose.

### Claim 6 (depends on 4)

The dry formulation of claim 4, further comprising a maltodextrin.

### Claim 7 (depends on 4)

The dry formulation of claim 4, wherein the dry formulation comprises a maltodextrin in an amount from 20% to 45% by weight; carrageenan or a salt thereof, in an amount from 10% to 20% by weight; microcrystalline cellulose, in an amount from 15% to 35% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 8

A dry formulation adapted for reconstituting with water to form a liquid formulation for treating oral injury, oral inflammation and/or oral pain, the dry formulation comprising:
one or more hydrophilic polymers, at least one of which is selected from the group consisting of:
pyrrolidones,
hyaluronic acids and salts thereof;
alginic acids and salts thereof;
carrageenans and salts thereof;
celluloses;
dextrins;
and mixtures thereof; wherein said hydrophilic polymers are present in an amount between 4% to 85%, based on the total weight of the dr formulation;
from 2.5% to 7% by weight, based on the total weight of the dry formulation, of one or more calcium salts;
from 0.4% to 1.2% by weight, based on the total weight of the dry formulation, of one or more phosphate salts;
sodium chloride, in an amount of at least 5% by weight; calcium chloride, in an amount of at least 2.5% by weight;
sodium phosphate (dibasic), in an amount of at least 0.25% by weight;
sodium phosphate (monobasic), in an amount of at least 0.25% by weight;
a maltodextrin, in an amount from 20% to 45% by weight;
a carrageenan or a salt thereof, in an amount from 10% to 20% by weight;
a microcrystalline cellulose, in an amount from 15% to 35% by weight;
fumed silica, in an amount from about 0.1% to 1.2% by weight; and
sodium bicarbonate, in an amount from 5% to 25% by weight,
wherein the weight percentages are based on total weight of the dry formulation.

### Claim 9 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises sodium chloride, in an amount of at least 5% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 10 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises calcium chloride, in an amount of at least 2.5% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 11 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises sodium phosphate (dibasic), in an amount of at least 0.25% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 12 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises sodium phosphate (monobasic), in an amount of at least 0.25% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 13 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises a maltodextrin, in an amount from 20% to 45% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 14 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises a carrageenan or a salt thereof, in an amount from 10% to 20% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 15 (depends on 1)

The dr formulation of claim 1, wherein the dry formulation comprises a microcrystalline cellulose, in an amount from 15% to 35% by weight, wherein the weight percentages are based on total weight of the dr formulation.

### Claim 16 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises fumed silica, in an amount from about 0.1% to 1.2% by weight, wherein the weight percentages are based on total weight of the dry formulation.

### Claim 17 (depends on 1)

The dry formulation of claim 1, wherein the dry formulation comprises sodium bicarbonate, in an amount from 5% to 25% by weight, wherein the weight percentages are based on total weight of the dry formulation.