Pharmaceutical oral patch for controlled release of pharmaceutical agents in the oral cavity

Abstract

The invention is directed to a controlled-release solid composition for the oral cavity or “pharmaceutical oral patch” that adheres to hard dental surfaces, such as teeth and dentures, and releases an active pharmaceutical agent into the oral cavity. Release of the agent is for a predetermined period of time and at a predetermined sustained concentration. The site of action of the agent is local or systemic.

What is claimed is:  
     
         1 . A dual-component oral composition for providing sustained or controlled release of a pharmaceutically active agent therefrom, comprising an adhesive component that is effective for adhering to teeth or dentures, said adhesive component comprising at least one polymer and said adhesive component being immediately adjacent to and adhered to a non-adhesive component, said non-adhesive component containing a pharmaceutically active agent, and from which non-adhesive component said agent is released into the oral cavity in therapeutically effective amounts when said adhesive component is adhered to teeth, dentures, or other hard surface, both components being suitable to remain in the oral cavity for a period of time necessary to allow release of a therapeutically effective amount of said agent into the oral cavity.  
     
     
         2 . The composition of    claim 1   , wherein said adhesive component comprises an adhesive selected from the group consisting of carbopol, acrylates, polyacrylates, polysaccharides, polymethacrylates and gums.  
     
     
         3 . The composition of    claim 1   , wherein said nonadhesive component comprises a sustained-release polymer selected from the group consisting of polyacrylate, polymethacrylate, cellulose derivatives, ethylcellulose, hydroxypropylmethyl cellulose, cellulose acetate phthalate, polysaccharide, guar gum, pectin, alginic acid and salts thereof, xanthan gum, gum tragacanth, gum arabic, starch, chitin, chitosan, proteins, polyamino acids, polypeptides, gelatin, polyglycolic acid, polylactic acid, polyglycolic-polylactic copolymers, cross-linked polysaccharides, and cross-linked proteins.  
     
     
         4 . The composition of    claim 3   , wherein said polymethacrylate polymer is a Eudragit™ polymer.  
     
     
         5 . The Eudragit™ polymer of    claim 4   , wherein said Eudragit™ polymer is Eudragit™ polymer.  
     
     
         6 . The composition of    claim 1   , wherein said adhesive component and said non-adhesive component are degradable so that said composition is degradable.  
     
     
         7 . The composition of    claim 1   , wherein said adhesive layer contains a pharmaceutically active agent and from which adhesive component said agent is released into the oral cavity in therapeutically effective amounts when said adhesive component is adhered to teeth, dentures, or other hard surface.