Water soluble film for oral administration with instant wettability

Abstract

A composition containing therapeutic agents and/or breath freshening agents for use in the oral cavity is disclosed. The carrier comprises water-soluble polymers in combination with certain ingredients and provides a therapeutic and/or cosmetic effect. The film is coated and dried utilizing existing coating technology and exhibits instant wettability followed by rapid dissolution/disintegration upon administration in the oral cavity.

1 - 9 . (canceled) 
     
     
         10 . A film comprising:
 i. at least one water-soluble polymer,   ii. at least one polyalcohol, and   iii. at least one pharmaceutically active ingredient.   
     
     
         11 . A film according to  claim 10  wherein the at least one polyalcohol is selected from the group consisting of glycerol, propylene glycol, glycerol esters with fatty acids and other pharmaceutically used polyalcohols. 
     
     
         12 . A film according to  claim 11  wherein the concentration of the at least one water-soluble polymer is between 20 and 75% (w/w). 
     
     
         13 . A film according to  claim 11  wherein the concentration of the at least one polyalcohol is between 0.1 and 5% (w/w). 
     
     
         14 . A film according to  claim 10  wherein the concentration of at least one pharmaceutically active ingredient is between 0.01 and 20% (w/w). 
     
     
         15 . A film according to  claim 10  wherein at least one pharmaceutically active ingredient is selected from the group of narcotics. 
     
     
         16 . A film according to  claim 10  wherein the film has a thickness between 5 and 200 μm. 
     
     
         17 . A film according to  claim 16  wherein the film has a thickness between 5 and 70 μm. 
     
     
         18 . A film according to  claim 10  further comprising at least one member of the group consisting of colorants, sweetening agents, flavours, and flavour enhancers. 
     
     
         19 . A film according to  claim 10  further comprising tartaric acid. 
     
     
         20 . A film according to  claim 10  further comprising citric acid. 
     
     
         21 . A film according to  claim 10  further comprising vanillin. 
     
     
         22 . A film according to  claim 10  wherein
 i. a first water-soluble polymer is a water-soluble cellulose derivative and 
 ii. a second water-soluble polymer is selected from the group consisting of polyvinyl pyrrolidone, polyvinyl alcohol and polyethylene glycol. 
 
     
     
         23 . A film according to  claim 22  wherein the water-soluble cellulose derivative is selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose. 
     
     
         24 . A film according to  claim 10  wherein a first water-soluble polymer is hydroxypropylmethyl cellulose and a second water-soluble polymer is polyethylene glycol. 
     
     
         25 . A film according to  claim 10  wherein the film is capable to release at least one pharmaceutically active ingredient to the oral cavity. 
     
     
         26 . A film according to  claim 10  wherein the film is rapidly dissolving. 
     
     
         27 . A film according to  claim 10  wherein the film is mucoadhesive. 
     
     
         28 . A film comprising
 i. a first water-soluble polymer which is a water-soluble cellulose derivative selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose,   ii. a second water-soluble polymer which is selected from the group consisting of polyvinyl pyrrolidone, polyvinyl alcohol and polyethylene glycol, and   iii. at least one pharmaceutically active ingredient.   
     
     
         29 . A film according to  claim 28  wherein at least one pharmaceutically active ingredient is selected from the group of narcotics. 
     
     
         30 . A film according to  claim 28  wherein a first water-soluble polymer is hydroxypropylmethyl cellulose and a second water-soluble polymer is polyethylene glycol. 
     
     
         31 . A film according to  claim 28  wherein the concentration of at least one water-soluble polymer is between 20 and 75% (w/w). 
     
     
         32 . A film according to  claim 28  wherein the concentration of polyethylene glycol is between 20 and 75% (w/w). 
     
     
         33 . A film according to  claim 28  further comprising at least one polyalcohol. 
     
     
         34 . A film according to  claim 28  wherein the concentration of the at least one pharmaceutically active ingredient is between 0.01 and 20% (w/w). 
     
     
         35 . A film according to  claim 28  wherein the concentration of at least one pharmaceutically active ingredient selected from the group of narcotics is between 0.01 and 20% (w/w). 
     
     
         36 . A film according to  claim 28  wherein the film has a thickness between 5 and 200 μm. 
     
     
         37 . A film according to  claim 36  wherein the film has a thickness of between 5 and 70 μm. 
     
     
         38 . A film according to  claim 28  further comprising at least one member of the group consisting of colorants, sweetening agents, flavours, and flavour enhancers. 
     
     
         39 . A film according to  claim 28  further comprising tartaric acid. 
     
     
         40 . A film according to  claim 28  further comprising citric acid. 
     
     
         41 . A film according to  claim 28  further comprising vanillin. 
     
     
         42 . A film according to  claim 28  wherein the film is capable to release the at least one pharmaceutically active ingredient to the oral cavity. 
     
     
         43 . A film according to  claim 28  wherein the film is rapidly dissolving. 
     
     
         44 . A film according to  claim 28  wherein the film is mucoadhesive. 
     
     
         45 . A film comprising:
 i. at least one water-soluble hydroxypropylmethyl cellulose,   ii. at least one water-soluble polyethylene glycol in a concentration of between 20 and 75% (w/w),   iii. and at least one pharmaceutically active ingredient selected from the group of narcotics in a concentration of between 0.01 and 20% (w/w).   
     
     
         46 . A film according to  claim 45  further comprising at least one polyalcohol, at least one colorant, at least one sweetening agent, and citric acid.