# US 10,117,823 B2 · Dental composition comprising chelator and base

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- Number: US 10,117,823 B2
- Document ID: US10117823B2
- Status: Granted
- Kind: B2
- Application number: 14/775,959
- Filed: 2014-03-12
- Published: 2016-02-04
- Granted: 2018-11-06
- Earliest claimed: 2013-03-12
- Assignees: Primal Therapies, Inc.
- Applicants: Primal Therapies, Inc.
- Inventors: Emily A. Stein
- Web page: https://patentgrep.com/patent/US10117823B2

## CPC

- A61K 8/738: {Cyclodextrins}
- A61K 8/11: Encapsulated compositions
- A61K 8/19: containing inorganic ingredients
- A61K 8/365: Hydroxycarboxylic acids; Ketocarboxylic acids
- A61K 8/41: Amines
- A61K 8/44: Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
- A61K 8/4926: {having six membered rings}
- A61K 8/55: Phosphorus compounds
- A61K 8/64: Proteins; Peptides; Derivatives or degradation products thereof
- A61K 8/66: Enzymes
- A61K 8/67: Vitamins
- A61K 8/676: {Ascorbic acid, i.e. vitamin C}
- A61K 8/73: Polysaccharides
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61Q 11/00: Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
- A61Q 17/005: {Antimicrobial preparations}
- A61Q 19/00: Preparations for care of the skin
- A61K 9/0063: {Periodont}
- A61K 2800/51: Chelating agents
- A61K 2800/592: Mixtures of compounds complementing their respective functions
- 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
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

Non-toxic consumable compositions and formulations having chelator and base are disclosed with synergistic effects on microbial metabolism and/or growth and/or pathogenic effectors and their use to promote and maintain health in mammals. The non-toxic consumable compositions have more than one chelator and/or more than one base. Methods for selecting said chelator and base composition and methods for detecting conditions in which selected compositions may be used are also disclosed. The synergistic compositions and methods can be used for maintaining health, promoting health and treating diseases.

## Claims

### Claim 1

A solid dosage form comprising a cyclodextrin and base, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

### Claim 2 (depends on 1)

The solid dosage form of claim 1, wherein the amount of the cyclodextrin is between 0.0005% and 30% of the solid dosage form.

### Claim 3 (depends on 1)

The solid dosage form of claim 1, wherein the amount of base is between 0.0001% and 15% of the solid dosage form.

### Claim 4 (depends on 1)

The solid dosage form of claim 1, further comprising an enhancer.

### Claim 5 (depends on 4)

The solid dosage form of claim 4, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the amount is between 0.0001% and 10% of the solid dosage form.

### Claim 6 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form is for oral care.

### Claim 7 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form is formulated in a tablet, powder, paste, deodorant, anti-perspirant, capsule, rapid melt tablet, thin strip, or gum.

### Claim 8 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form is formulated for administration at least once per day.

### Claim 9 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form is used to promote oral health.

### Claim 10 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form is for use following consumption of a phosphoric acid or ascorbic acid containing beverage.

### Claim 11 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form is for use following consumption of food.

### Claim 12

A method of promoting oral health in a mammal comprising:
identifying an individual at increased risk for developing or exhibiting signs of oral disease;
measuring pH, leukocyte esterase, nitrate, microbial marker levels, or plaque-staining dye retention in the mouth of the individual;
comparing said levels to healthy levels to determine if oral pathology is present; and
contacting an effective amount of a solid dosage form comprising a cyclodextrin and base, to an oral surface if evidence of oral pathology is present, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

### Claim 13 (depends on 1)

The solid dosage form of claim 1, wherein the cyclodextrin and base are formulated for contact with a biological surface.

### Claim 14 (depends on 1)

The solid dosage form of claim 1, further comprising arginine or a polyarginine.

### Claim 15 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form has a pH range of approximately 4.2 to 7.2.

### Claim 16

A method of reducing pathogenic microbial activity, the method comprising:
contacting an effective amount of a solid dosage form comprising a cyclodextrin and base with a surface, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

### Claim 17 (depends on 16)

The method of claim 16, wherein the surface is a biological surface.

### Claim 18 (depends on 17)

The method of claim 17, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

### Claim 19 (depends on 16)

The method of claim 16, wherein the surface is an inanimate surface.

### Claim 20 (depends on 19)

The method of claim 19, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

### Claim 21 (depends on 16)

The method of claim 16, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 22 (depends on 16)

The method of claim 16, wherein the solid dosage form further comprises an enhancer.

### Claim 23 (depends on 22)

The method claim 22, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the amount is between 0.0001% and 10% of the solid composition.

### Claim 24 (depends on 22)

The method of claim 22, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 25

A method of promoting oral health in an individual comprising administering an effective amount of a solid dosage form comprising a cyclodextrin and base to the individual, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

### Claim 26 (depends on 25)

The method of claim 25, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 27 (depends on 25)

The method of claim 25, wherein the individual has one or more of halitosis, tooth plaque, tooth decay, periodontitis, gingivitis and cavity.

### Claim 28 (depends on 25)

The method of claim 25, wherein the solid dosage form further comprises an enhancer.

### Claim 29 (depends on 28)

The method of claim 28, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the amount of the enhancer is between 0.0001% and 10% of the solid dosage form.

### Claim 30 (depends on 28)

The method of claim 28, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 31 (depends on 25)

The method of claim 25, wherein the solid dosage form has a pH range of approximately 4.2 to 7.2.

### Claim 32 (depends on 25)

The method of claim 25, wherein the solid dosage form has a pH range of approximately 6 to 9.

### Claim 33 (depends on 25)

The method of claim 25, wherein the solid dosage form is administered following consumption of a phosphoric acid or ascorbic acid containing beverage.

### Claim 34 (depends on 25)

The method of claim 25, wherein the solid dosage form is administered following consumption of food.

### Claim 35 (depends on 1)

The solid dosage form of claim 1, wherein the cyclodextrin and base are formulated for contact with an inanimate surface.

### Claim 36 (depends on 35)

The solid dosage form of claim 35, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

### Claim 37 (depends on 13)

The solid dosage form of claim 13, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

### Claim 38 (depends on 1)

The solid dosage form of claim 1, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 39 (depends on 5)

The solid dosage form of claim 5, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 40 (depends on 1)

The solid dosage form of claim 1, wherein the solid dosage form has a pH range of approximately 6 to 9.

### Claim 41

A liquid composition comprising a cyclodextrin and base, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.

### Claim 42 (depends on 41)

The liquid composition of claim 41, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 43 (depends on 41)

The liquid composition of claim 41, wherein the concentration of the cyclodextrin is between 0.0005% and 30% of the liquid composition.

### Claim 44 (depends on 41)

The liquid composition of claim 41, wherein the concentration of base is between 0.0001% and 15% of the liquid composition.

### Claim 45 (depends on 41)

The liquid composition of claim 41, further comprising an enhancer.

### Claim 46 (depends on 45)

The liquid composition of claim 45, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the concentration is between 0.0001% and 10% of the liquid composition.

### Claim 47 (depends on 45)

The liquid composition of claim 45, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 48 (depends on 41)

The liquid composition of claim 41, wherein the liquid composition is for oral care.

### Claim 49 (depends on 41)

The liquid composition of claim 41, wherein the liquid composition is formulated as a spray, deodorant, anti-perspirant, cream, gel, concentrate, wipe, or wash.

### Claim 50 (depends on 49)

The liquid composition of claim 49, wherein the wash is a mouthwash.

### Claim 51 (depends on 41)

The liquid composition of claim 41, wherein the liquid composition has a pH range of approximately 4.2 to 7.2.

### Claim 52 (depends on 41)

The liquid composition of claim 41, wherein the liquid composition has a pH range of approximately 6 to 9.

### Claim 53 (depends on 41)

The liquid composition of claim 41, wherein the cyclodextrin and base are formulated for contact with a biological surface.

### Claim 54 (depends on 53)

The liquid composition of claim 53, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

### Claim 55 (depends on 41)

The liquid composition of claim 41, wherein the cyclodextrin and base are formulated for contact with an inanimate surface.

### Claim 56 (depends on 55)

The liquid composition of claim 55, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

### Claim 57

A method of reducing pathogenic microbial activity, the method comprising contacting an effective amount of a liquid composition comprising a cyclodextrin and base with a surface, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.

### Claim 58 (depends on 57)

The method of claim 57, wherein the surface is a biological surface.

### Claim 59 (depends on 58)

The method of claim 58, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

### Claim 60 (depends on 57)

The method of claim 57, wherein the surface is an inanimate surface.

### Claim 61 (depends on 60)

The method of claim 60, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

### Claim 62 (depends on 57)

The method of claim 57, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 63 (depends on 57)

The method of claim 57, wherein the liquid composition further comprises an enhancer.

### Claim 64 (depends on 63)

The method of claim 63, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the concentration is between 0.0001% and 10% of the liquid composition.

### Claim 65 (depends on 63)

The method of claim 63, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 66

A method of promoting oral health in an individual comprising administering an effective amount of a liquid composition comprising a cyclodextrin and base to the individual, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.

### Claim 67 (depends on 66)

The method of claim 66, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 68 (depends on 66)

The method of claim 66, wherein the individual has one or more of halitosis, tooth plaque, tooth decay, periodontitis, gingivitis and cavity.

### Claim 69 (depends on 66)

The method of claim 66, wherein the liquid composition further comprises an enhancer.

### Claim 70 (depends on 69)

The method of claim 69, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the concentration is between 0.0001% and 10% of the liquid composition.

### Claim 71 (depends on 69)

The method of claim 69, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

### Claim 72 (depends on 66)

The method of claim 66, wherein the liquid composition has a pH range of approximately 4.2 to 7.2.

### Claim 73 (depends on 66)

The method of claim 66, wherein the liquid composition has a pH range of approximately 6 to 9.

### Claim 74 (depends on 66)

The method of claim 66, wherein the liquid composition is administered following consumption of a phosphoric acid or ascorbic acid containing beverage.

### Claim 75 (depends on 66)

The method of claim 66, wherein the liquid composition is administered following consumption of food.

### Claim 76

A method of promoting oral health in a mammal comprising:
identifying an individual at increased risk for developing or exhibiting signs of oral disease;
measuring pH, leukocyte esterase, nitrate, microbial marker levels, or plaque-staining dye retention in the mouth of the individual;
comparing said levels to healthy levels to determine if oral pathology is present; and
contacting an effective amount of a liquid composition comprising a cyclodextrin and base to an oral surface if evidence of oral pathology is present, and wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.
