Fluoride varnish compositions including an organo phosphoric acid adhesion promoting agent

• US 8,852,561 B2
• Filed: 02/07/2013
• Issued: 10/07/2014
• 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): Krass, Frederick
• Assistant Examiner(s): Cohen, Michael P
• Application Number:
  US13/761,884
• Publication Number:
  US 20130149391A1
• Time in Patent Office: 607 Days
• Field of Search: None
• US Class Current: 424/57
• 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 coating of a tooth surface, comprising:

a substantially water-insoluble resin;

an organo phosphoric acid having an alkyl group that contains no polymerizable groups in an amount that promotes adhesion of the varnish composition, including the substantially water-insoluble resin, to tooth surfaces while reducing running or dripping of the varnish composition compared to a composition without the organo phosphoric acid; and

a fluoride ion source.

2. A fluoride varnish composition as in claim 1, wherein the resin and organo phosphoric acid comprise a sticky, adhesive liquid carrier phase that is formulated to temporarily adhere to tooth surfaces.

3. A fluoride varnish composition as in claim 1, wherein the resin is included in an amount of about 30% to about 80% by weight of the fluoride varnish composition.

4. A fluoride varnish composition as in claim 1, wherein the organo phosphoric acid is included in an amount of about 1% to about 20% by weight of the fluoride varnish composition.

5. A fluoride varnish composition as in claim 1, wherein the varnish composition has a viscosity and consistency so as to facilitate painting of the composition onto tooth surfaces.

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

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

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

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

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

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

12. A fluoride varnish composition as in claim 11, wherein the alkyl phosphoric acid comprises an alkyl group having from about 3 to about 30 carbon atoms.

13. A fluoride varnish composition as in claim 11, wherein the alkyl phosphoric acid comprises an alkyl group having from about 10 to about 25 carbon atoms.

14. A fluoride varnish composition as in claim 11, wherein the alkyl phosphoric acid comprises an alkyl group having from about 15 to about 22 carbon atoms.

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

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

17. A fluoride varnish composition as recited in claim 16, wherein the natural resin comprises at least one of shellac or colophonium.

18. A fluoride varnish composition as in claim 1, further comprising at least one rheology modifying agent.

19. A fluoride varnish composition as in claim 18, wherein the rheology modifying agent comprises fumed silica.

20. A fluoride varnish composition as in claim 1, further comprising at least one of a sweetener or flavorant.

21. A fluoride varnish composition as 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.

22. A fluoride varnish composition as in claim 1, wherein the fluoride ion source is included in a range from about 1% to about 8% by weight.

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

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

25. A fluoride varnish composition as in claim 1, further comprising a solvent.

26. A fluoride varnish composition as in claim 1, further comprising a solubilizing agent.

27. A fluoride varnish composition for temporary coating of a tooth surface, comprising:

an adhesive liquid carrier phase comprising a substantially water-insoluble resin in an amount of about 30% to about 80% by weight and an organo phosphoric acid having an alkyl group that contains no polymerizable groups in an amount of about 1% to about 20%, wherein the sticky, adhesive liquid carrier phase adheres temporarily to tooth tissue; and

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

wherein the varnish composition has a viscosity and consistency so as to facilitate painting onto tooth surfaces and wherein the organo phosphoric acid improves adhesion of the varnish composition to tooth surfaces.

28. A fluoride varnish composition as in claim 27, further comprising a solubilizing agent.

29. A fluoride varnish composition as in claim 27, further comprising a solvent.