Oral formulation of polyglucosamine derivatives in combination with a non-fermentable sugar

Abstract

Described herein are methods and compositions that contain a soluble polyglucosamine or polyglucosamine derivative for use in oral health. The compositions are useful for, e.g., reducing bacteria (e.g., by clumping and removing) or disrupting a biofilm in the mouth of a subject, reducing dry mouth, and reducing oral inflammation.

1 . An oral care composition comprising:
 a non-fermentable sugar (e.g., sorbitol, xylitol) and   a poly (acetyl, arginyl) glucosamine (PAAG), wherein PAAG comprises the following formula (I):   
       
         
           
           
               
               
           
         
         wherein: 
         n is an integer between 20 and 6000; and 
         each R 1  is independently selected for each occurrence from hydrogen, acetyl, 
       
       
         
           
           
               
               
           
         
         wherein at least 25% of R 1  substituents are H, at least 1% of R 1  substituents are acetyl, 
         and at least 2% of R 1  substituents are 
       
       
         
           
           
               
               
           
         
       
       and
 the molecular weight of the PAAG is from 20 to 200 kDa. 
 
     
     
         2 . The composition of  claim 1 , further comprising:
 a thickener (e.g., glycerin),   a surfactant (e.g., Polysorbate 20),   a flavoring agent, or   a preservative (e.g., benzoic acid).   
     
     
         3 - 7 . (canceled) 
     
     
         8 . The composition of  claim 1 , wherein the non-fermentable sugars and PAAG are present in the composition at an amount of about 15% to about 70% w/v. 
     
     
         9 . (canceled) 
     
     
         10 . The composition of  claim 1 , wherein the PAAG is present in the composition at an amount of at least 0.003% to about 0.05% w/v of PAAG. 
     
     
         11 - 15 . (canceled) 
     
     
         16 . The composition of  claim 1 , wherein sorbitol is present in the composition at an amount between about 5% to about 35% by weight. 
     
     
         17 . (canceled) 
     
     
         18 . The composition of  claim 1 , wherein xylitol is present in the composition at an amount between about 2% to about 15% by weight. 
     
     
         19 - 45 . (canceled) 
     
     
         46 . The composition of  claim 1 , wherein the PAAG is functionalized at between 18% and 30%. 
     
     
         47 . The composition of  claim 1 , wherein the pH is about 6 to about 8. 
     
     
         48 - 49 . (canceled) 
     
     
         50 . An oral care composition comprising:
 a plurality non-fermentable sugars (e.g., sorbitol and xylitol) in an amount from about 10% to about 65% w/v,   glycerin in an amount from about 1% to about 20% w/v,   polysorbate 20 in an amount from about 0.5% to about 2.5% w/v,   peppermint oil in an amount from about 0.01% to about 0.3% w/v,   benzoic acid in an amount from about 0.01% to about 4.0% w/v, and   a PAAG in an amount from about 0.001 to about 0.8% w/v.   
     
     
         51 - 52 . (canceled) 
     
     
         53 . A method of treating or preventing an oral disease or a symptom of oral disease, the method comprising administering to the subject an effective amount of an oral care composition comprising PAAG. 
     
     
         54 . The method of  claim 53 , wherein the oral disease is periodontitis; gingivitis; dental caries; dental plaque; halitosis; swollen gums; mouth sores; bright-red, or purple gums; shiny gums; swollen gums that emit pus; severe oral odor; gums that are painless, except when pressure is applied; gums that bleed easily, even with gentle brushing, and especially when flossing; gums that itch with varying degrees of severity; or toothache. 
     
     
         55 . (canceled) 
     
     
         56 . The method of  claim 53 , the method further comprising a step of administering an antibiotic or antiseptic to a subject, in a dose to achieve a synergistic effect. 
     
     
         57 . The method of  claim 56 , wherein the antibiotic or antiseptic is metronidazole, hydrogen peroxide, cetylpryridinium chloride, xylitol, or chlorhexidine. 
     
     
         58 . The method of  claim 53 , the method further comprising a step of physically removing superficial layers of bacteria and related debris from the mouth through use of mechanical or ultrasonic debridement. 
     
     
         59 . The method of  claim 58 , wherein the composition contacts the mouth for about 0.5 to about 2 minutes. 
     
     
         60 - 61 . (canceled) 
     
     
         62 . The method of  claim 58 , wherein the composition is used 1 to 6 times daily. 
     
     
         63 - 64 . (canceled) 
     
     
         65 . The method of  claim 58 , wherein the effective amount is about 5 to about 30 mL of the composition. 
     
     
         66 - 79 . (canceled)