Fluoride varnish compositions including an organo phosphoric acid adhesion promoting agent

• US 8,383,163 B2
• Filed: 12/19/2008
• Issued: 02/26/2013
• Est. Priority Date: 01/29/2008
• Status: Active Grant

• Current Assignee: Ultradent Products Incorporated
• Original Assignee: Ultradent Products Incorporated
• Inventors: Wagner, Jeff A., Kawamoto, Andy T.
• Primary Examiner(s): Gulledge, Brian
• Assistant Examiner(s): COHEN, MICHAEL P
• Application Number:
  US12/339,382
• Publication Number:
  US 20090191279A1
• Time in Patent Office: 1,530 Days
• Field of Search: None
• US Class Current: 424/606
• CPC Class Codes: A61K 33/16 Fluorine compounds
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 8/21 Fluorides; Derivatives thereof
• CPC Class Codes: A61K 8/55 Phosphorus compounds
• 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

Fluoride varnish compositions for temporary application and adhesion to a person'"'"'s teeth. The composition includes a carrier comprising a resin and an adhesion promoting agent comprising an alkyl phosphoric acid. A fluoride ion source (e.g., a fluoride salt such as sodium fluoride) is dispersed within the carrier so as to provide biologically available fluoride ions to the tooth tissue being treated. The composition adheres only temporarily to tooth tissue (e.g., for a period of at least about 4 minutes, but not more than about 1 year), after which the composition spontaneously wears away as a natural result of the action of the tongue, saliva and/or other factors.

Claims

1. A fluoride varnish composition for temporary application to a person'"'"'s tooth surfaces, comprising:

a sticky, adhesive liquid carrier phase for application and temporary adhesion to tooth surfaces, the liquid carrier phase comprising;

a substantially water-insoluble resin included in an amount in a range of about 30% to about 80% by weight of the fluoride varnish composition; and

an adhesion promoting agent that promotes adhesion of the fluoride varnish composition to tooth surfaces, the adhesion promoting agent comprising an organo phosphoric acid having at least one alkyl group and included in an amount in a range of about 1% to about 20% by weight of the fluoride varnish composition, and wherein the sticky, adhesive liquid carrier phase comprising the substantially-water insoluble resin and the adhesion promoting agent adheres temporarily to exposed tooth surfaces; and

a fluoride ion source dispersed within the sticky, adhesive liquid carrier phase,

wherein the fluoride varnish composition has a viscosity and consistency so as to facilitate painting of the composition onto tooth surfaces and wherein the adhesion promoting agent improves adhesion of the fluoride varnish composition to the tooth surfaces.

2. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition is substantially colorless.

3. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition is formulated so as to remain adhered to tooth surfaces so as to provide fluoride treatment for at least about 2 hours.

4. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition is formulated so as to remain adhered to tooth surfaces so as to provide fluoride treatment for at least about 1 day.

5. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition is formulated so as to degrade or spontaneously wear away in less than about 90 days after being placed on a tooth.

6. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition is formulated so as to degrade or spontaneously wear away in less than about 5 days.

7. A fluoride varnish composition as recited in claim 1, wherein the organo phosphoric acid comprises an alkyl phosphoric acid.

8. A fluoride varnish composition as recited in claim 7, wherein the alkyl phosphoric acid comprises an alkyl group having from about 3 to about 30 carbon atoms.

9. A fluoride varnish composition as recited in claim 7, wherein the mono-alkyl phosphoric acid comprises an alkyl group having from about 10 to about 25 carbon atoms.

10. A fluoride varnish composition as recited in claim 7, wherein the mono-alkyl phosphoric acid comprises an alkyl group having from about 15 to about 22 carbon atoms.

11. A fluoride varnish composition as recited in claim 7, wherein the mono-alkyl phosphoric acid comprises at least one of hexadecyl phosphoric acid or docosyl phosphoric acid.

12. A fluoride varnish composition as recited in claim 1, wherein the organo phosphoric acid is included in a range of about 5% to about 8% by weight of the fluoride varnish composition.

13. A fluoride varnish composition as recited in claim 1, wherein the organo phosphoric acid is included in a range of about 3% to about 10% by weight of the fluoride varnish composition.

14. A fluoride varnish composition as recited in claim 1, wherein the resin comprises a natural resin.

15. A fluoride varnish composition as recited in claim 14, wherein the natural resin comprises at least one of shellac or colophonium.

16. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition further comprises at least one rheology modifying agent.

17. A fluoride varnish composition as recited in claim 16, wherein the rheology modifying agent comprises fumed silica.

18. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition further comprises at least one of a sweetener or flavorant.

19. A fluoride varnish composition as recited in claim 1, wherein the fluoride ion source comprises at least one of NaF, BiF₃, SnF₂, ZnF₂, KF, CaF₂, ZrF₄, sodium mono-fluorophosphate (Na₂FPO₃), hexafluorosilicic acid, or sodium hexafluorosilicate.

20. A fluoride varnish composition as recited in claim 1, wherein the fluoride ion source is included in an amount from about 1% to about 8% by weight of the fluoride varnish composition.

21. A fluoride varnish composition as recited in claim 1, wherein the fluoride ion source is included in an amount from about 3% to about 7% by weight of the fluoride varnish composition.

25. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition has a viscosity of less than 1000 centipoise.

26. A fluoride varnish composition as recited in claim 1, wherein the fluoride varnish composition has a viscosity from about 200 centipoise to about 600centipoise.

22. A fluoride varnish composition for temporary application to a person'"'"'s tooth surfaces, comprising:

a sticky, adhesive liquid carrier phase comprising a substantially water-insoluble resin in an amount in a range of about 30% to about 80% by weight of the fluoride varnish composition and an adhesion promoting agent, the adhesion promoting agent comprising a mono-alkyl phosphoric acid in an amount in a range of about 1% to about 20% by weight of the fluoride varnish composition in order to promote adhesion of the fluoride varnish composition to tooth surfaces, the alkyl group having from about 3 to about 30 carbon atoms, and wherein the sticky, adhesive liquid carrier phase adheres temporarily to tooth tissue; and

a fluoride ion source dispersed within the sticky, adhesive liquid carrier phase,

wherein the fluoride varnish composition has a viscosity and consistency so as to facilitate painting of the composition onto tooth surfaces and wherein the adhesion promoting agent improves adhesion of the fluoride varnish composition to the tooth surfaces.

27. A fluoride varnish composition as recited in claim 22, wherein the water-insoluble resin comprises a natural resin and wherein the fluoride ion source is included in an amount from about 1% to about 8% by weight of the fluoride varnish composition.

23. A fluoride varnish composition for temporary application to a person'"'"'s tooth surfaces, comprising:

a sticky, adhesive liquid carrier for application and temporary adhesion to tooth surfaces, the liquid carrier phase comprising;

a substantially water-insoluble natural resin; and

an adhesion promoting agent in an amount so as to promote adhesion of the carrier to tooth surfaces, the adhesion promoting agent comprising at least one organo phosphoric acid having at least one alkyl group

wherein the carrier adheres temporarily to tooth surfaces, and wherein the adhesion promoting agent reduces running or dripping of the fluoride varnish composition compared to a composition formulated without the adhesion promoting agent; and

a fluoride ion source dispersed within the carrier.

28. A fluoride varnish composition as recited in claim 23, further comprising a solvent.

29. A fluoride varnish composition as recited in claim 23, further comprising a solubilizing agent.

24. A fluoride varnish composition for temporary application to a person'"'"'s tooth surfaces, comprising:

a sticky, adhesive liquid carrier for application and temporary adhesion to tooth surfaces, the liquid carrier phase comprising;

a substantially water-insoluble resin; and

an adhesion promoting agent in an amount so as to promote adhesion of the carrier to tooth surfaces, the adhesion promoting agent comprising an organo phosphoric acid having at least one alkyl group,

and wherein the carrier comprising the substantially-water insoluble resin and the adhesion promoting agent adheres temporarily to exposed tooth surfaces, and wherein the adhesion promoting agent reduces running or dripping of the fluoride varnish composition compared to a composition formulated without the adhesion promoting agent; and

a fluoride ion source dispersed within the carrier and included in an amount from about 1% to about 8% by weight of the fluoride varnish composition.

30. A fluoride varnish composition as recited in claim 24, further comprising a solvent.

31. A fluoride varnish composition as recited in claim 24, further comprising a solubilizing agent.