Enhanced Anti-Carious Dentifrices, Rinses, Lozenges, Candies and Chewing Gums and Methods of Using Same

Abstract

Mouth rinses, dentifrices, lozenges, confections, chewing gums, and similar delivery vehicles containing non-toxic soluble calcium are used prior to administration of a fluoride-containing composition to increase the effectiveness of the fluoride therapy. An effective amount of calcium is released into the oral cavity and allowed to penetrate into the oral tissue. Calcium-bound fluoride deposits form in the oral tissue upon subsequent administration of the fluoride-containing composition to provide increased salivary, plaque and oral tissue fluoride concentrations.

What is claimed is: 
     
         1 . A two-part system for releasing calcium ions to oral tissue and thereby enhancing the cariostatic effect of subsequently administered fluoride, the system comprising:
 a first delivery vehicle having a soluble calcium concentration of at least about 30 millimoles per liter (mMol/L), and   a second delivery vehicle having a soluble fluoride-containing compound for forming calcium-bound fluoride deposits in the oral tissue, following reaction with calcium ions released from the first delivery vehicle that have penetrated into the oral tissue,   wherein the two-part delivery system is formulated to enhance salivary fluoride concentration, relative to the use of the second delivery vehicle alone.   
     
     
         2 . The two-part system of  claim 1 , wherein the first delivery vehicle has a soluble calcium concentration from about 30 mMol/L to about 400 mMol/L. 
     
     
         3 . The two-part system of  claim 1 , wherein the first delivery vehicle has a soluble calcium concentration from about 40 mMol/L to about 300 mMol/L. 
     
     
         4 . The two-part system of  claim 1 , wherein the first and second delivery vehicles are in respective, separate first and second delivery vehicle forms independently selected from the group consisting of a rinse, a dentifrice, a lozenge, a confection, and a chewing gum. 
     
     
         5 . The two-part system of  claim 4 , wherein the first delivery vehicle form and the second delivery vehicle form are separate rinses. 
     
     
         6 . The two-part system of  claim 4 , wherein the first delivery vehicle form is a lozenge or a chewing gum having a total calcium content from about 0.0001 moles to about 0.01 moles. 
     
     
         7 . The two-part system of  claim 4 , wherein the first delivery vehicle form is a dentifrice having from about 0.002 grams to about 0.5 grams of soluble calcium per gram. 
     
     
         8 . The two-part system of  claim 1 , wherein the first and second delivery vehicles are contained as separate outer and inner layers, respectively of a lozenge, a confection, or a chewing gum. 
     
     
         9 . The two-part system of  claim 1 , wherein the second delivery vehicle is encapsulated within the first delivery vehicle in a lozenge, a confection, or a chewing gum. 
     
     
         10 . The two-part system of  claim 1 , wherein the second delivery vehicle comprises phosphate in an amount of less than about 40 parts per million (ppm) by weight. 
     
     
         11 . A composition for enhancing the anticaries effect of fluoride, the composition comprising:
 a soluble calcium-containing compound that is a calcium salt having a solubility of about 0.5 grams per liter or more, and   a fluoride-containing compound,   wherein the composition is formulated to release calcium ions from the calcium-containing compound, and subsequently release fluoride, into the oral cavity, in amounts and at times sufficient to increase retention of the fluoride, compared to administration of the fluoride-containing compound alone.   
     
     
         12 . The composition of  claim 11 , wherein the soluble calcium-containing compound is a calcium salt of an acid selected from the group consisting of gluconic acid, lactic acid, fumaric acid, glycerophosphoric acid, hydrochloric acid, citric acid, acetic acid, propionic acid, sulfuric acid, and nitric acid. 
     
     
         13 . The composition of  claim 11 , wherein the soluble calcium-containing compound and the fluoride-containing compound are present in first and second delivery vehicles, respectively. 
     
     
         14 . The composition of  claim 13 , wherein the first delivery vehicle has a concentration of soluble calcium of at least about 30 millimoles per liter (mMol/L). 
     
     
         15 . The composition of  claim 14 , wherein the first delivery vehicle has a concentration of soluble calcium from about 40 mMol/L to about 300 mMol/L. 
     
     
         16 . The composition of  claim 13 , wherein the second delivery vehicle comprises phosphate in an amount of less than about 40 parts per million (ppm) by weight. 
     
     
         17 . The composition wherein the first and second delivery vehicles are in the forms of separate rinses. 
     
     
         18 . A composition for enhancement of anticaries activity of fluoride upon administration in an oral cavity, the composition comprising:
 a calcium-containing compound comprising calcium in an amount effective for providing a soluble calcium concentration in the oral cavity of at least about 30 millimoles per liter (mMol/L); and   a fluoride-containing compound separate from the calcium-containing compound, the composition providing the sequential release of (i) calcium from the calcium containing compound and (ii) fluoride from the fluoride-containing compound, the release of fluoride occurring after released calcium has passed at least in part into oral tissue.   
     
     
         19 . The composition of  claim 18 , wherein the calcium-containing compound is in a pre-rinse and the fluoride-containing composition is in a fluoride rinse, wherein the composition is formulated to increase retention of the fluoride in the oral cavity by sequential administration of the pre-rinse and fluoride rinse, compared to administration of the fluoride rinse alone, as well as minimize the formation of fluoroapatite. 
     
     
         20 . The composition of  claim 18 , wherein the calcium-containing compound is selected from the group consisting of calcium gluconate, calcium lactate, calcium fumarate, calcium glycerophosphate, calcium chloride, calcium citrate, calcium acetate, calcium propionate, calcium sulfate, calcium nitrate, and mixtures thereof.