Use of statins for periodontal disease and bone regeneration

Abstract

Topical compositions comprising at least one statin as the main active compound for primary prevention or treatment of periodontal disease, for complementing standard treatment of periodontal disease, and for bone regeneration. The topical compositions are formulated for example, but not limited to, as toothpaste, mouthwash, tablets to dissolve in the mouth, elements or devices for intraoral slow-release of statins, dental floss, gel for being applied in dental trays, concentrated gel for irrigation of periodontal pockets, fluid (for example in blisters), powder, powder or liquid for preparing a solution, and gel. The present invention also discloses method for primary prevention or treatment of periodontal disease, for complementing standard treatment of periodontal disease, and for bone regeneration, comprising administering the topical compositions in the different formulations to a subject in need thereof.

1 . A topical composition for primary prevention or treatment of human or animal periodontal disease, wherein the composition comprises at least one statin or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The topical composition for primary prevention or treatment according to  claim 1 , wherein the at least one statin is selected from the group consisting of lovastatin, pravastatin, simvastatin, fluvastatin, cerivastatin, atorvastatin, and a pharmaceutically acceptable salt thereof. 
     
     
         3 . The topical composition for primary prevention or treatment according to  claim 2 , wherein the composition comprises 2% calcium atorvastatin. 
     
     
         4 . The topical composition for primary prevention or treatment according to  claim 3 , wherein the composition can also comprise a component selected from the group consisting of one or more pharmaceutically acceptable carriers, vehicles, additives, excipients, solvents, adjuvants, dyes, flavorings, sweetenings, binders, emollients, fillers, lubricants, preservatives, diluents, thickeners, salts for influencing osmoting pressure, buffers, disintegrants, glidants, wettings, humectants, abrasive agents, surfactants, therapeutic agents (such as anticavities, antiplaque, agents for reducing hypersensitivity, and bleaching agents), or combinations thereof. 
     
     
         5 . The topical composition for primary prevention or treatment according to  claim 3 , wherein the composition is formulated as a toothpaste, a mouthwash, tablets to dissolve in the mouth, elements or devices for intraoral slow-release of statins, or dental floss with at least one statin as the main active agent. 
     
     
         6 . The topical composition for primary prevention or treatment according to  claim 5 , wherein the composition is a toothpaste composition. 
     
     
         7 . The topical composition for primary prevention or treatment according to  claim 3 , wherein the composition can be incorporated into beef, pork, lamb, chicken and/or turkey bones, cartilages or any substance the animal can chew, or into animal feed as cookies and pellet when the composition is used for treating animals. 
     
     
         8 . (canceled) 
     
     
         9 . The topical composition for primary prevention or treatment according to  claim 4 , wherein the topical composition comprises:
 200 mg of calcium atorvastatin;   5 mg of menthol,   5 mg of sodium fluoride,   250 mg of Lutrol gel.   
     
     
         10 . A topical composition for complementing standard treatment of human or animal periodontal disease, wherein the composition comprises at least one statin or a pharmaceutically acceptable salt thereof, wherein the at least one statin is selected from the group consisting of lovastatin, pravastatin, simvastatin, fluvastatin, cerivastatin, atorvastatin, and a pharmaceutically acceptable salt thereof. 
     
     
         11 . (canceled) 
     
     
         12 . The topical composition for complementing standard treatment of human or animal periodontal disease according to  claim 10 , wherein the composition comprises 2% calcium atorvastatin. 
     
     
         13 . The topical composition for complementing standard treatment of human or animal periodontal disease according to  claim 12 , wherein the composition can also comprise one or more components selected from the group consisting of pharmaceutically acceptable carriers, vehicles, additives, excipients, solvents, adjuvants, dyes, flavorings, sweetenings, binders, emollients, fillers, lubricants, preservatives, diluents, thickeners, salts for influencing osmoting pressure, buffers, disintegrants, glidants, wettings, humectants, abrasive agents, surfactants, therapeutic agents (such as anticavities, antiplaque, agents for reducing hypersensitivity, bleaching agents), and combinations thereof. 
     
     
         14 . The topical composition for complementing standard treatment according to  claim 12 , wherein the composition is formulated as a concentrated gel for being applied in dental trays or for irrigation of periodontal pockets with at least one statin as the main active agent. 
     
     
         15 . The topical composition for complementing standard treatment according to  claim 12 , wherein the composition can be incorporated into beef, pork, lamb, chicken and/or turkey bones, cartilages or any substance the animal can chew, or into animal feed as cookies and pellet when the composition is used for treating animals. 
     
     
         16 . The topical composition for complementing standard treatment according to  claim 15 , wherein the animals are dogs and cats. 
     
     
         17 . A topical composition for human or animal bone regeneration, wherein the composition comprises at least one statin or a pharmaceutically acceptable salt thereof, wherein the at least one statin is selected from the group consisting of lovastatin, pravastatin, simvastatin, fluvastatin, cerivastatin, atorvastatin, and a pharmaceutically acceptable salt thereof. 
     
     
         18 . (canceled) 
     
     
         19 . The topical composition for human or animal bone regeneration according to  claim 17 , wherein the composition comprises 2% calcium atorvastatin. 
     
     
         20 . The topical composition for human or animal bone regeneration according to  claim 19 , wherein the compositions is formulated in a form selected from the group consisting of a concentrated composition, a fluid, a powder, a powder, and a liquid for preparing a solution, and a gel, intended for direct application in bone defects or for application through a vehicle with graft materials, membranes and endo-osseous dental implants. 
     
     
         21 . The topical composition for human or animal bone regeneration according to  claim 19 , wherein the composition can be incorporated into beef, pork, lamb, chicken and/or turkey bones, cartilages or any substance the animal can chew, or into animal feed as cookies and pellet when the composition is used for treating animals. 
     
     
         22 . The topical composition for human or animal bone regeneration according to  claim 21 , wherein the animals are dogs and cats. 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . The topical composition according to  claim 6 , wherein the toothpaste composition further comprises one or more component selected from the group consisting of pharmaceutically acceptable carriers, vehicles, additives, excipients, solvents, adjuvants, dyes, flavourings, sweetenings, binders, emollients, fillers, lubricants, preservatives, diluents, thickeners, salts for influencing osmoting pressure, buffers, disintegrants, glidants, wettings, humectants, abrasive agents, surfactants, anticavities, antiplaque, agents for reducing hypersensitivity, bleaching agents, and combinations thereof. 
     
     
         27 .- 28 . (canceled)