Oral delivery system

Abstract

The present invention provides a delivery system for the treatment and/or prevention of infectious pathological changes, including compositions comprising polyhexanide, various pharmaceutical formulations, and processes for using these formulations in oral treatment modalities.

We claim: 
     
         1 . A chewing gum comprising polyhexanide in an amount effective to treat infectious pathological changes in the mouth and throat. 
     
     
         2 . The gum of  claim 1 , wherein the gum further comprises at least one suspending agent or humectant selected from the group consisting of water, glycerin, propylene glycol, sorbitol syrup, and combinations thereof. 
     
     
         3 . The gum of  claim 1 , wherein the gum further comprises at least one thickening agent, stabilizer, or binder. 
     
     
         4 . The gum of  claim 3 , wherein the at least one thickening agent, stabilizer, or binder is selected from the group consisting of a gel, a starch, an alginate, an oil, a cellulose gum, and combinations thereof. 
     
     
         5 . The gum of  claim 1 , wherein the gum further comprises a gum base selected from the group consisting of chicle, gutta-percha, latex, benzoin resin, and gum arabic. 
     
     
         6 . The gum of  claim 1 , wherein the gum comprises a synthetic thermoplastic gum base. 
     
     
         7 . The gum of  claim 6 , wherein the synthetic thermoplastic is selected from the group consisting of polyvinyl acetate, polybutadiene styrene, polyisobutylene, isoprene, polyvinyl ether, and polyethylene. 
     
     
         8 . The gum of  claim 1 , wherein the gum comprises a filler selected from the group consisting of magnesium stearate, chalk, calcium carbonate, a silicate, and a cellulose. 
     
     
         9 . The gum of  claim 1 , wherein the gum comprises at least one aromatic substance, sweetener, or sugar substitute. 
     
     
         10 . The gum of  claim 9 , wherein the at least one aromatic substance, sweetener, or sugar substitute is selected from the group consisting of menthol, peppermint oil, sodium saccharin, aspartame, acesulfame, sorbitol, maltitol, xylitol, fructose, and combinations thereof. 
     
     
         11 . The gum of  claim 1 , wherein the gum comprises an emulsifier, a resin, a wax, or glucitol. 
     
     
         12 . The gum of  claim 1 , wherein the gum comprises an abrasive selected from the group consisting of calcium carbonate, calcium phosphate, a metaphosphate, silicic acid, an aluminum oxide, a silicate, talcum, and combinations thereof. 
     
     
         13 . The gum of  claim 1 , wherein the gum comprises fluoride. 
     
     
         14 . The gum of  claim 1 , wherein polyhexanide is the only agent present in an antibacterially effective amount. 
     
     
         15 . The gum of  claim 1 , wherein the gum comprises fluoride and at least one aromatic substance, sweetener, or sugar substitute. 
     
     
         16 . The gum of  claim 5 , wherein fluoride and the at least one aromatic substance, sweetener, or sugar substitute are not present in antibacterially effective amounts. 
     
     
         17 . A method of treating infectious pathological changes in the mouth and throat comprising administering the gum of  claim 1  to a patient in need thereof. 
     
     
         18 . The method of  claim 7 , wherein the infectious pathological change is a periodontal disease. 
     
     
         19 . The method of  claim 7 , wherein the infectious pathological change is gingivitis, periodontitis, or peri-implantitis. 
     
     
         20 . A method of delivering, polyhexanide into a gingival pocket, the method comprising administering to a patient in need thereof the gum of  claim 1 .