Remineralizaing-mineralizing oral products containing discrete cationic and anionic agglomerate components and method of use

• US 20020176828A1
• Filed: 05/03/2002
• Published: 11/28/2002
• Est. Priority Date: 06/01/1999
• Status: Active Grant

• Current Assignee: Anthony E. Winston, Jordan Barth, Norman Usen
• Original Assignee: Anthony E. Winston, Jordan Barth, Norman Usen
• Inventors: Barth, Jordan, Usen, Norman, Winston, Anthony E.
• Granted Patent: US 6,482,395 B1
• Time in Patent Office: Days
• US Class Current: 424/57
• CPC Class Codes: A61K 2800/88 Two- or multipart kits
• CPC Class Codes: A61K 8/19 containing inorganic ingredients
• CPC Class Codes: A61K 8/24 Phosphorous; Compounds thereof
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

A solid oral product, e.g., chewing gum, lozenge, an edible foodstuff, and the like, which is useful for remineralizing subsurface dental lesions and/or mineralizing exposed dentinal tubules, contains (A) a discrete cationic agglomerate component composed of at least one water-soluble or partially water-soluble calcium salt and a first inert solid carrier, and (B) a discrete anionic agglomerate component composed of at least one water-soluble orthophosphate salt and a second inert solid carrier. The agglomerate nature of the cationic and anionic components keeps these components separate from one another during storage of the product but allows the cationic and anionic salts to be simultaneously released from the product upon mixing of the product with water and/or saliva to form a mixed aqueous solution such that the solution contains both calcium cations released from the calcium salt and orthophosphate anions released by the orthophosphate salt.

Claims

1. A solid oral product capable of effecting remineralization of subsurface dental lesions and/or mineralization of exposed dentinal tubules, comprising:

(A) a discrete cationic agglomerate component comprising at least one water-soluble or partially water-soluble calcium salt and a first inert solid carrier, and

(B) a discrete anionic agglomerate component comprising at least one water-soluble orthophosphate salt and a second inert solid carrier;

wherein components (A) and (B) have a pH in water such that a mixed aqueous solution formed by mixing components (A) and (B) with water and/or saliva has a pH of from about 4.5 to about 10.0;

further wherein the cationic and anionic agglomerate components are simultaneously releasable from the product upon mixing of the product with water and/or saliva to form the mixed aqueous solution such that the mixed aqueous solution comprises calcium cations released from the calcium salt and orthophosphate anions released by the orthophosphate salt.

2. A product according to claim 1, wherein one or both of the first and second solid inert carriers is selected from the group consisting of sorbitol, mannitol, and xylitol.

3. A product according to claim 1, wherein one or both of the first and second solid inert carriers is an insoluble silica or an insoluble calcium phosphate.

4. A product according to claim 3, wherein the insoluble calcium phosphate is selected from the group consisting of dicalcium phosphate dihydrate, anhydrous dicalcium phosphate, tricalcium phosphate and calcium hydroxyapatite.

5. A product according to claim 1, wherein one or both of the cationic and anionic agglomerate components further comprises a binder.

6. A product according to claim 5, wherein said binder is a polymer selected from the group consisting of polyvinyl acetate, PVP and carboxymethyl cellulose.

7. A product according to claim 1, wherein the cationic and anionic agglomerate components each have an average particle size ranging from about 20 to about 500 microns.

8. A product according to claim 1, wherein the cationic and anionic agglomerate components each have an average particle size ranging from about 30 to about 100 microns.

9. A product according to claim 1, wherein the product has a smooth consistency and the cationic and anionic agglomerate components each have an average particle size of from about 30 to about 50 microns.

10. A product according to claim 1, wherein the product has a crunchy consistency and the cationic and anionic agglomerate components each have an average particle size of from about 50 to about 80 microns.

11. A product according to claim 1, wherein components (A) and (B) have a pH in water such that the mixed aqueous solution has a pH of from about 5.0 to about 8.0.

12. A product according to claim 1, wherein components (A) and (B) have a pH in water such that the mixed aqueous solution has a pH of from about 5.5 to about 7.0.

13. A product according to claim 1, wherein the calcium salt is a water-soluble calcium salt selected from the group consisting of calcium chloride, calcium nitrate, calcium acetate, calcium lactate, calcium gluconate, and mixtures thereof.

14. A product according to claim 1, wherein the calcium salt is calcium nitrate.

15. A product according to claim 1, wherein the calcium salt is a partially water-soluble calcium salt selected from the group consisting of calcium sulfate, anhydrous calcium sulfate, calcium sulfate hemihydrate, calcium sulfate dihydrate, calcium malate, calcium tartrate, calcium malonate and calcium succinate.

16. A product according to claim 1, wherein the calcium salt is calcium sulfate.

17. A product according to claim 1, wherein the orthophosphate salt is selected from the group consisting of alkali metal salts of orthophosphoric acid and ammonium salts of orthophosphoric acid.

18. A product according to claim 1, wherein the orthophosphate salt is selected from the group consisting of potassium orthophosphate, sodium orthophosphate, ammonium orthophosphate, monopotassium orthophosphate, dipotassium orthophosphate, tripotassium orthophosphate, monosodium orthophosphate, disodium orthophosphate and trisodium orthophosphate.

19. A product according to claim 1, wherein the cationic agglomerate component further comprises at least one non-toxic divalent metal salt other than a calcium salt.

20. A product according to claim 1, wherein the anionic agglomerate component further comprises at least one water-soluble fluoride salt.

21. A product according to claim 1, wherein the oral product is selected from the group consisting of chewing gums, lozenges, tablets, edible food products, candy, dragees, and pastilles.

22. A product according to claim 1, wherein the solid product is a chewing gum and the product further comprises (C) a gum base.

24. A method according to claim 23, wherein the product provided in step (1) is a chewing gum, and step (2) is effected by chewing the product.

25. A method according to claim 23, wherein the product provided in step (1) is a candy or a lozenge, and step (2) is effected by sucking the product.

26. A method according to claim 23, wherein the product provided in step (1) is a toothpowder or a foodstuff, and step (2) is effected by eating the product.

23. A method for remineralizing at least one subsurface lesion in at least one tooth and/or mineralizing at least one exposed dentinal tubule in the at least one tooth, comprising the steps of:

(1) providing a solid oral product comprising;

(A) a discrete cationic agglomerate component comprising at least one water-soluble or partially water-soluble calcium salt and a first inert solid carrier, and

(B) a discrete anionic agglomerate component comprising at least one water-soluble orthophosphate salt and a second inert solid carrier;

wherein components (A) and (B) have a pH in water such that a mixed aqueous solution formed by mixing components (A) and (B) with water and/or saliva has a pH of from about 4.5 to about 10.0;

further wherein the cationic and anionic agglomerate components are simultaneously releasable from the product upon mixing of the product with water and/or saliva to form the mixed aqueous solution such that the mixed aqueous solution comprises calcium cations released from the calcium salt and orthophosphate anions released by the orthophosphate salt;

(2) contacting the product with water and/or saliva so as to form a mixed aqueous solution having a pH of from about 4.5 to about 10.0 and comprising calcium cations released by the calcium salt and orthophosphate ions released by the orthophosphate salt; and

(3) contacting the at least one tooth with the mixed aqueous solution for a period of time sufficient to allow a remineralizing/mineralizing amount of the calcium anions and a remineralizing/mineralizing amount of the orthophosphate anions to diffuse through the tooth to a subsurface thereof, wherein the diffused calcium cations and the diffused orthophosphate anions react together to form calcium hydroxyapatite onto the subsurface lesion and/or onto the exposed dentinal tubule, thereby remineralizing said lesion and/or mineralizing said exposed dentinal tubule.