Stannous oral compositions

Abstract

Disclosed are oral compositions comprising a stannous ion source, a fluoride ion source, and a polymeric mineral surface active agent that binds stannous, said compositions providing adequate therapeutic efficacy with minimal side effects of tooth staining and astringency. The composition simultaneously provides reduction and control of supragingival calculus. The present oral care compositions may be formulated as single phase or dual phase compositions. The present invention also provides a method for effective delivery of stannous-containing compositions with minimal side effects of tooth staining or astringency and with effective tartar control by administering to a subject a stable dentifrice composition comprising a clinically effective amount of stannous fluoride and/or other stannous salts in combination with a fluoride ion source and a polymeric mineral surface active agent, preferably a phosphate- or phosphonate-containing polymer.

1 . An oral composition having antimicrobial activity effective for reducing plaque and gingivitis, said composition comprising: 
 a. a stannous ion source that comprises a stannous salt and delivers from about 3,000 ppm to about 15,000 ppm stannous ions,    b. a fluoride ion source, and    c. a condensed phosphorylated polymer,    wherein said condensed phosphorylated polymer agent binds stannous ions and is substantive to mineral surfaces.    
     
     
         2 . The oral composition according to  claim 1  wherein the fluoride ion source is capable of providing from about 50 ppm to about 3500 ppm of fluoride ions.  
     
     
         3 . The oral composition according to  claim 1  comprising from about 1% to about 35% of the condensed phosphorylated polymer.  
     
     
         4 . The oral composition according to  claim 3  wherein the phosphorylated polymer is a condensed linear polyphosphate having an average chain length of about 4 or more, wherein said polyphosphate is water-soluble and susceptible to hydrolysis.  
     
     
         5 . The oral composition according to  claim 1  wherein the fluoride ion source comprises stannous fluoride.  
     
     
         6 . The oral composition according to  claim 5  wherein the stannous ion source comprises stannous chloride dihydrate.  
     
     
         7 . The oral composition according to  claim 6  additionally comprising a gluconate salt.  
     
     
         8 . The oral composition according to  claim 4  wherein the molar ratio of polyphosphate anion to stannous ion is from about 0.2:1 to about 5:1.  
     
     
         9 . The oral composition according to  claim 4  wherein the condensed polyphosphate has an average chain length of about 21.  
     
     
         10 . The oral composition according to  claim 1  wherein the stannous ion source and fluoride ion source are physically separated from the condensed phosphorylated polymer.  
     
     
         11 . The oral composition according to  claim 1  wherein the ratio of the composition's in-vitro Plaque Glycolysis Regrowth Model score to the composition's in-vitro Pellicle Tea Stain Model score is at least about 1.2.  
     
     
         12 . The oral composition according to  claim 1  wherein the composition's in-vitro Plaque Glycolysis Regrowth Model score is at least about 60%.  
     
     
         13 . The oral composition according to  claim 1  wherein the composition's in-vitro Pellicle Tea Stain Model score is less than about 75%.  
     
     
         14 . The oral composition according to  claim 12  wherein the composition's in-vitro Plaque Glycolysis Regrowth Model score is at least about 70%.  
     
     
         15 . The oral composition according to  claim 12  wherein the composition's in-vitro Plaque Glycolysis Regrowth Model score is at least about 80%.  
     
     
         16 . The oral composition according to  claim 13  wherein the composition's in-vitro Pellicle Tea Stain Model score is less than about 60%.  
     
     
         17 . The oral composition according to  claim 13  wherein the composition's in-vitro Pellicle Tea Stain Model score is less than about 50%.  
     
     
         18 . The oral composition according to  claim 13  wherein the composition's in-vitro Pellicle Tea Stain Model score is less than about 25%.  
     
     
         19 . The oral composition according to  claim 1  wherein the oral composition is substantially free of alkali metal pyrophosphate salt.  
     
     
         20 . The oral formulation according to  claim 1  wherein the oral composition additionally comprises a poloxamer.