Compositions and methods for the treatment of xerostomia

Patent metadata

Field	Value
Publication number	US-10471283-B2
Application number	US-86663009-A
Country	US
Kind code	B2
Filing date	Feb 6, 2009
Priority date	Feb 8, 2008
Publication date	Nov 12, 2019
Grant date	Nov 12, 2019

Abstract

The present invention is directed to methods and compositions comprising a basic amino acid, e.g., arginine, for the treatment of dry mouth.

First claim

The invention claimed is:

1. A method to treat, ameliorate, inhibit, or prevent dry mouth in a person that either has xerostomia, is diagnosed with a disease or injury that predisposes the person to xerostomia or is being treated with a medication that predisposes the person to xerostomia, the method comprising administering to the oral cavity of the person a composition comprising a basic amino acid, in free or salt form, and zinc citrate;
wherein the basic amino acid is arginine or arginine bicarbonate, and the arginine is L-arginine; and
wherein the composition further comprises one or more compounds selected from the group consisting of:
(a) a calcium ion source;
(b) a phosphate ion source;
(c) a potassium ion source;
(d) a magnesium ion source;
(e) a fluoride ion source;
(f) a flavorant which promotes saliva flow; and
(g) a polyol humectant; and

wherein the fluoride ion source is selected from stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and combinations thereof, and
wherein the composition has a pH between about 6.8 and 7.2.

2. The method of claim 1 wherein dry mouth is chronic.

3. The method of claim 1 wherein the composition is a dentifrice.

4. The method of claim 1 wherein the composition is a mouth rinse.

5. The method of claim 4 wherein the mouth rinse is an artificial saliva further comprising one or more of: a fluoride ion source, a calcium ion source, a phosphate ion source, a potassium ion source, and combinations thereof.

6. The method of claim 3 , wherein the one or more compounds is a combination of a calcium ion source and a polyol humectant.

7. The method of claim 6 , wherein the basic amino acid is arginine bicarbonate in an amount from about 0.1% to about 20% by weight and the polyol humectant is present in an amount from 15% to about 70% by weight.

8. The method of claim 7 , wherein
the calcium ion source is selected from the group consisting of calcium carbonate, calcium chloride, calcium lactate, dicalcium phosphate and combinations thereof; and
the polyol humectant is selected from the group consisting of glycerol, sugar alcohols, sorbitol, xylitol and combinations thereof.

9. The method of claim 8 , wherein the calcium ion source is calcium carbonate and the composition further comprises a carboxymethylcellulose and a hydrated silica.

10. The method of claim 9 , wherein the polyol humectant is glycerol.

11. The method of claim 4 , wherein the one or more compounds is a combination of a calcium ion source, a phosphate ion source, a potassium ion source, a magnesium ion source, a fluoride ion source and a polyol humectant.

12. The method of claim 11 , wherein the basic amino acid is arginine in an amount from about 0.1% to about 20% by weight and the polyol humectant is present in an amount from 15% to about 70% by weight.

13. The method of claim 12 , wherein
the calcium ion source is selected from the group consisting of calcium carbonate, calcium chloride, calcium lactate, dicalcium phosphate and combinations thereof;
the phosphate ion source is selected from potassium phosphate monobasic, dibasic potassium phosphate, dicalcium phosphate, sodium monofluorophosphate and combinations thereof;
the potassium ion source is selected from the group consisting of potassium nitrate, potassium chloride, potassium phosphate monobasic, dibasic potassium phosphate and combinations thereof;
the magnesium ion source is magnesium chloride; and
the polyol humectant is selected from the group consisting of glycerol, sugar alcohols, sorbitol, xylitol and combinations thereof.

14. The method of claim 13 , wherein
the calcium ion source is calcium chloride;
the phosphate ion source comprises potassium phosphate monobasic; and
the potassium ion source is potassium chloride.

15. The method of claim 14 , wherein
the phosphate ion source further comprises dibasic potassium phosphate; and
the composition further comprises a hydroxyethyl cellulose.

16. The method of claim 15 , wherein the polyol humectant is xylitol.

Assignees

• Kohli Rajnish
• Robinson Richard Scott
• Sullivan Richard J
• Cummins Diane
• Jayaraman Nagaraja
• Filadelfi Keszi Maryann
• Colgate Palmolive Co

Inventors

• Kohli Rajnish
• Robinson Richard Scott
• Sullivan Richard J
• Cummins Diane
• Jayaraman Nagaraja
• Filadelfi-Keszi Maryann

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P1/02

  Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title

• A61K31/198

  Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) · CPC title

• A61K9/00

  Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)} · CPC title