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 . A composition applicable to the oral cavity comprising a mucoadhesive film, said mucoadhesive film comprising a homogeneous mixture consisting of a water-soluble polymer, a polyalcohol, a cosmetically and/or pharmaceutically active agent, and a flavor.  
     
     
         2 . A composition according to    claim 1   , wherein the water-soluble polymer is hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthane gum, tragacantha, guar gum acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, or mixtures thereof.  
     
     
         3 . A composition according to    claim 1   , wherein the concentration of the water-soluble polymer in the dry film lies between 20 and 75%.  
     
     
         4 . A composition according to    claim 1   , wherein the mixture contains as optional ingredients one or more plasticizers or surfactants.  
     
     
         5 . A composition according to    claim 4   , wherein component one of the surfactant mixture is a polyoxyethylene sorbitan fatty acid ester or a α-hydro-ω-hydroxypoly(oxyethylene) poly(oxypropylene) poly(oxyethylene) block copolymer.  
     
     
         6 . A composition according to    claim 4   , wherein component two of the surfactant mixture is a polyoxyethylene alkyl ether or a polyoxyethylene castor oil derivative.  
     
     
         7 . A composition according to    claim 1   , wherein the polyalcohol is selected from glycerol, polyethylene glycol, propylene glycol, or glycerol monoesters with fatty acids.  
     
     
         8 . A composition according to    claim 1   , wherein the therapeutic agent is selected from the group of hypnotics, sedatives, antiepileptics, awakening agents, psychoneurotropic agents, neuromuscular blocking agents, antispasmodic agents, antihistaminics, antiallergics, cardiotonics, antiarrhythmics, diuretics, hypotensives, vasopressors, antitussive expectorants, thyroid hormones, sexual hormones, antidiabetics, antitumor agents, antibiotics and chemotherapeutics, or narcotics.  
     
     
         9 . A composition according to    claim 1   , wherein the cosmetically active agent may include breath freshening compounds like menthol, or other flavors or fragrances commonly used for oral hygiene, and/or agents used for dental and/or oral cleansing like quarternary ammonium bases.