Chewing gum products and the use thereof for remineralizing subsurface dental lesions and for mineralizing exposed dentinal tubules

• US 5,958,380 A
• Filed: 07/07/1997
• Issued: 09/28/1999
• Est. Priority Date: 07/07/1997
• Status: Expired due to Term

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Enamelon Incorporated
• Inventors: Usen, Norman, Winston, Anthony E.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US08/888,623
• Time in Patent Office: 813 Days
• Field of Search: 424/48-58, 424/440, 426/3
• US Class Current: 424/48
• CPC Class Codes: A61K 8/19 containing inorganic ingredients
• CPC Class Codes: A61K 8/24 Phosphorous; Compounds thereof
• CPC Class Codes: A61K 8/345 containing more than one hydroxy group
• CPC Class Codes: A61K 8/365 Hydroxycarboxylic acids; Ketocarboxylic acids
• CPC Class Codes: 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
• 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

This invention relates to a stable, single-part chewing gum product and methods of using same to effect remineralization of subsurface lesions in teeth and/or mineralization of exposed dentinal tubules. The chewing gum product contains a water-soluble cationic portion, a water-soluble anionic portion and a stabilizing component which substantially inhibits reaction between the cationic and anionic portions during storage of the chewing gum product but which allows the cationic and anionic portions to be simultaneously released at a substantially equal rate from the product when the product is chewed in the presence of saliva and/or water. The cationic portion is composed of at least one water-soluble calcium salt, and the anionic portion contains at least one water-soluble phosphate and, optionally, at least one water-soluble fluoride salt. The stabilizing component may be at least one water-soluble divalent metal salt other than calcium salt, the divalent metal salt being disposed in the cationic portion of the product. Alternatively, the stabilizing component may be a desiccating agent or an encapsulating coating, wherein the encapsulating coating is disposed on particles of one or both of the cationic and anionic portions.

Claims

1. A stable, single-part chewing gum product capable of remineralizing at least one subsurface lesion and/or mineralizing at least one exposed dentinal tubule in at least one tooth, comprising:

(A) a water-soluble cationic portion containing an effective amount of at least one water-soluble calcium salt;

(B) a water-soluble anionic portion containing an effective amount of at least one water-soluble phosphate salt;

(C) an effective amount of a stabilizing component which is capable of substantially inhibiting reaction between the cationic and anionic portions during storage of the chewing gum product, wherein upon chewing of the chewing gum product in an oral cavity in the presence of water and/or saliva, the stabilizing component is further capable of allowing the cationic and anionic portions to be simultaneously released at a substantially equal rate from the chewing gum product into the water and/or saliva, the release of the cationic and anionic portions into the water and/or saliva yielding a mixed aqueous solution, the cationic and anionic portions each having a pH in water such that the mixed aqueous solution has a pH of from greater than about 4.0 to about 7.0; and

(D) a gum base.

2. A product according to claim 1, wherein the cationic and anionic portions each have a pH in water such that the pH of the mixed aqueous solution ranges from about 5.0 to about 5.75.

3. A product according to claim 1, wherein the product comprises from about 0.01% to about 15.0% by weight of the calcium salt and from about 0.01% to about 15.0% by weight of the phosphate salt.

4. A product according to claim 1, wherein the calcium salt is selected from the group consisting of calcium chloride, calcium bromide, calcium nitrate, calcium acetate, calcium gluconate, calcium benzoate, calcium glycerophosphate, calcium formate, calcium fumarate, calcium lactate, calcium butyrate, calcium isobutyrate, calcium malate, calcium maleate, calcium propionate, and mixtures of the foregoing.

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

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

7. A product according to claim 1, wherein the phosphate salt is selected from the group consisting of monopotassium phosphate, dipotassium phosphate and tripotassium phosphate.

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

9. A product according to claim 8, wherein the product comprises no more than about 0.1% by weight of said fluoride salt.

10. A product according to claim 8, wherein said fluoride salt is selected from the group consisting of sodium fluoride, potassium fluoride, lithium fluoride, ammonium fluoride, tin fluoride, indium fluoride, zirconium fluoride, copper fluoride, nickel fluoride, palladium fluoride, fluorozirconates, fluorosilicates, fluoroborates, fluorostannites, amine fluorides, alkali metal monofluorophosphates, ammonium monofluorophosphates, and aluminum monofluorophosphates.

11. A product according to claim 8, wherein said fluoride salt is sodium fluoride.

12. A product according to claim 8, wherein said fluoride salt is sodium monofluorophosphate.

13. A product according to claim 1, wherein said stabilizing component is at least one non-toxic, water-soluble divalent metal compound, wherein the divalent metal is other than calcium, further wherein the divalent metal compound is disposed in the cationic portion of the product.

14. A product according to claim 13, wherein said product comprises more than about 0.0002% by weight of said divalent metal compound.

15. A product according to claim 13, wherein said divalent metal is selected from the group consisting of magnesium, strontium, tin, and zinc.

16. A product according to claim 13, wherein said divalent metal is magnesium.

17. A product according to claim 13, wherein said divalent metal compound is selected from the group consisting of magnesium chloride, magnesium acetate and magnesium oxide.

18. A product according to claim 1, wherein said stabilizing component is a desiccating agent.

19. A product according to claim 18, wherein said product comprises from about 1.0% to about 7.5% by weight of said desiccating agent.

20. A product according to claim 18, wherein said desiccating agent is selected from the group consisting of magnesium sulfate, sodium sulfate, calcium sulfate, calcium chloride and colloidal silica.

21. A product according to claim 1, wherein said product comprises from about 5.0% to about 95.0% by weight of said gum base.

22. A stable, one-part, dry mix composition which is capable of being mixed with a gum base to form the chewing gum product of claim 1, said dry-mix composition comprising:

(a) from about 1.0% to 80.0% by weight of at least one water-soluble calcium salt;

(b) from about 1.0% to 80.0% by weight of at least one water-soluble phosphate salt;

(c) from about 0.1% to 20.0% by weight of at least one non-toxic, water-soluble divalent metal salt wherein the divalent metal is other than calcium;

(d) and from 0 to about 1.0% of at least one water-soluble fluoride salt.

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

(1) providing a stable, single-part chewing gum product comprising;

(A) a water-soluble cationic portion containing an effective amount of at least one water-soluble calcium salt;

(B) a water-soluble anionic portion containing an effective amount of at least one water-soluble phosphate salt;

(C) an effective amount of a stabilizing component which is capable of substantially inhibiting reaction between the cationic and anionic portions during storage of the chewing gum product, wherein when the chewing gum product is chewed in an oral cavity in the presence of saliva and/or water, the stabilizing material is further capable of allowing the cationic and anionic portions to be released from the chewing gum product at a substantially equal rate such that the cationic and anionic portions are simultaneously released into the saliva and/or water to form a mixed aqueous solution therewith, the mixed aqueous solution containing anions released by the anionic portion and cations released by the cationic portion, the mixed aqueous solution simultaneously and directly delivering the anions and cations to at least one tooth surface in the oral cavity, the cationic and anionic portions each having a pH in water such that the mixed aqueous solution has a pH of from greater than about 4.0 to about 7.0; and

(D) a gum base; and

(2) chewing the chewing gum product in the oral cavity in the presence of said water and/or saliva, thereby causing the product to simultaneously release at a substantially equal rate the calcium salt and the phosphate salt into the water and/or saliva, thereby forming said mixed aqueous solution having a pH of from greater than about 4.0 to about 7.0 and containing calcium cations released by the calcium salt and phosphate anions released by the phosphate salt, the mixed aqueous solution simultaneously delivering the calcium cations and phosphate anions to a surface of said at least one tooth, wherein the mixed aqueous solution has a stability such that a sufficient amount of the calcium cations and a sufficient amount of the phosphate anions remain in a dissolved state for a period of time sufficient to allow said dissolved cations and dissolved anions to diffuse through said surface of the tooth to a subsurface of said tooth, wherein said dissolved, diffused cations and anions react at said subsurface to form an insoluble precipitate on said subsurface lesion and/or said exposed dentinal tubule, thereby effecting remineralization of said subsurface lesion and/or mineralization of said exposed dentinal tubule.

24. A method according to claim 23, wherein said chewing step (2) is carried out for a period of at least about 1 minute.

25. A method according to claim 23, wherein said chewing step (2) is carried out for a period of at least about 15 minutes.

26. A method according to claim 23, wherein the cationic and anionic portions each have a pH in water such that the pH of the mixed aqueous solution ranges from about 5.0 to about 5.75.

27. A method according to claim 23, wherein the anionic portion further comprises at least one water-soluble fluoride salt.

28. A method according to claim 23, wherein said stabilizing component is at least one non-toxic, water-soluble divalent metal compound, wherein the divalent metal is other than calcium, further wherein the divalent metal compound is disposed in the cationic portion of the product.

29. A method according to claim 28, wherein said product comprises more than about 0.0002% by weight of said divalent metal compound.

30. A method according to claim 28, wherein said divalent metal is selected from the group consisting of magnesium, strontium, tin, and zinc.

31. A method according to claim 28, wherein said divalent metal is magnesium.

32. A product according to claim 28, wherein said divalent metal compound is selected from the group consisting of magnesium chloride, magnesium acetate and magnesium oxide.

33. A method according to claim 23, wherein said stabilizing component is a desiccating agent.

34. A method according to claim 33, wherein said product comprises from about 1.0% to about 7.5% by weight of said desiccating agent.

35. A method according to claim 33, wherein said desiccating agent is selected from the group consisting of magnesium sulfate, sodium sulfate, calcium sulfate, calcium chloride and colloidal silica.