Oral compositions

Abstract

Oral compositions useful for controlling dental plaque and gingivitis and for preventing caries are produced comprising a cationic antimicrobial agent and an anti-stain agent which reduces the staining effect of the cationic antimicrobial.

What is claimed is: .[. 
     
       1.  An oral composition useful for controlling dental plaque and gingivitis and for preventing caries which comprises from 0.1% to about 1.0% w/w or w/v of a cationic antimicrobial agent otherwise tending to stain teeth, and useful for controlling dental plaque and gingivitis and for preventing caries selected from the group consisting of a bisbiguanide or quaternary ammonium compound and from 0.01% to 10.0% w/w or w/v of malic acid effective to inhibit said teeth staining, in combination with a pharmaceutically acceptable carrier..]. .[.2. A composition according to claim 1 wherein the amount of malic acid is from 0.1% to 1.0% w/w or w/v..]. .[.3. A composition according to claim 1 wherein the pH of the 
     
     
        composition is from about 5.0 to about 8.0..]. .[.4.  A composition according to claim 1 wherein the bisbiguanide is 1,6-bis(2-ethylhexyl diguanido hexane)dihydrochloride; 1,6-bis(2-ethylhexyl diguanido hexane)dihydrofluoride; 1,6-bis(2-ethylhexyl diguanido octane)dihydrochloride; 1,6-bis(2-ethylhexyl diguanido nonane)dihydrochloride; 1,6-bis(2-ethylhexyl diguanido dodecane)dihydrochloride; or 1,6-di(4-chlorophenyl diguanido hexane)dihydrochloride or the diacetate or digluconate salt thereof..]. .[.5. A composition according to claim 1 wherein the quaternary ammonium compound is dodecyl dimethyl(2-phenoxyethyl)-ammonium; benzyldimethyl(2-)2-(p-1,3,3-tetramethyl butyl phenoxy)ethoxyl)ethyl)ammonium; p-bromobenzyl-dimethyl-γ-(2'-isopropyl, 4'-chloro, 5'-methyl phenoxy)-propyl ammonium; 1-hexadecyl-pyridinium salt; acylcholaminoformyl-methyl pyridinium chloride-iodide complex; 1-alkyl-4-aminoquinaldinium salt; decamethylene bis(4-aminoquinaldinum chloride) or hexadecamethylene bis(isoquinolinium chloride)..]. .[.6. A composition according to claim 1 wherein the antimicrobial agent is alexidine dihydrochloride..]. .[.7. A composition according to claim 1 in mouthwash form..]. .[.8. A composition according to claim 1 in oral rinse form..]. .[.9. A composition according to claim 1 in dentifrice form..]. 
     
     
        .[.10.  A composition according to claim 1 in toothpowder form..]. .[.11. A composition according to claim 1 in oral solution form..]. .[.12. A composition according to claim 1 in gel form..]. .[.13. A composition according to claim 1 in a form suitable for dispensing through a water jet..]. .[.14. A composition according to claim 1 in a breath freshener form..]. .[.15. A composition according to claim 1 in an aerosol form..]. .[.16. A composition according to claim 1 in a gargle form..]. .[.17. A composition according to claim 1 in the form of a troche..]. .[.18. A composition according to claim 1 in lozenge form..]. .[.19. A composition according to claim 1 which comprises 0.035% w/v alexidine dihydrochloride, 0.382% w/v malic acid and purified water as the pharmaceutically acceptable carrier, the pH of the composition being between 5.0 and 8.0..]. .[.20. A composition according to claim 1 which comprises 0.035% w/v alexidine dihydrochloride, 15.0% w/v alcohol USP. 10.0% w/v glycerin USP, 0.04% w/v flavoring agent, 0.02% w/v sodium saccharin, 0.382% w/v malic acid, sufficient buffering agent to maintain the pH of the 
     
     
        composition between 5.0 and 8.0 and purified water UPS, q.s..]. .Iadd.21. In the art of inhibiting teeth staining caused by a cationic anti-microbial agent which is useful for controlling dental plaque and gingivitis and for preventing caries selected from the group consisting of a bisbiguanide or a quaternary ammonium compound, said cationic anti-microbial agent being utilized in an amount of from 0.01% to about 1.0% w/w or w/v, the improvement which consists essentially of the step of orally utilizing together with said cationic anti-microbial agent, an amount of malic acid effective to inhibit teeth staining caused by the otherwise useful cationic anti-microbial agent, said amount of malic acid being from 0.01% to 10.0% w/w or w/v. .Iaddend. .Iadd.22. The improvement according to claim 21 wherein the amount of malic acid is from 0.1% to 1.0% w/w or w/v. .Iaddend. .Iadd.23. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized 
     
     
        in mouthwash form. .Iaddend. .Iadd.24.  The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in oral rinse form. .Iaddend. .Iadd.25. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in dentifrice form. .Iaddend. .Iadd.26. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in toothpowder form. .Iaddend. .Iadd.27. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in oral solution form. .Iaddend. .Iadd.28. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in gel form. .Iaddend. .Iadd.29. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in a form suitable for dispensing through a water jet. .Iaddend. .Iadd.30. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in a breath freshener form. .Iaddend. .Iadd.31. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in an aerosol form. .Iaddend. .Iadd.32. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in a gargle form. .Iaddend. .Iadd.33. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in the form of a troche. .Iaddend. .Iadd.34. The improvement according to claim 21 wherein the cationic anti-microbial agent and the malic acid are utilized in the form of a lozenge. .Iaddend.