Orally administered agent and an orally administered agent/supporting substrate complex

Abstract

With an object of providing an orally administered agent (in particular a film-shaped orally administered agent) with which the ease and safety of taking the agent are improved, to attain this object, in an orally administered agent 1 b having one drug-containing layer 11 and two water-swellable gel-forming layers 12, the water-swellable gel-forming layers 12 are provided, either directly or via intermediate layers, on the both faces of the drug-containing layer 11.

1 . An orally administered agent comprising a plurality of drug-containing layers that contain a drug to be administered and a plurality of water-swellable gel-forming layers that contain a water-swellable gel-forming agent, wherein
 said drug containing layers are laminated together directly or heat-fused together via an intermediate layer, the intermediate layer comprising a heat-sealing adhesive, and   said water-swellable gel-forming layers are provided over the whole of the faces of both sides of the orally administered agent as an outermost layer.   
     
     
         2 . The orally administered agent according to  claim 1 , wherein
 said drug containing layers are heat-fused together via an intermediate layer that comprises a heat-sealing adhesive, and   said heat-sealing adhesive comprising a homopolymer of vinyl acetate, a homopolymer of vinyl pyrrolidone or a copolymer between vinyl acetate and vinyl pyrrolidone.   
     
     
         3 . The orally administered agent according to  claim 1 , wherein said orally administered agent is a film-shaped preparation. 
     
     
         4 . The orally administered agent according to  claim 1 , wherein said water-swellable gel-forming agent is at least one selected from a group consisting of carboxyvinyl polymers, starches and derivatives thereof, agar, alginic acid, arabinogalactan, galactomannan, dextran, pectin, gellan gum and xanthan gum. 
     
     
         5 . The orally administered agent according to  claim 1 , wherein said water-swellable gel-forming layer further comprises a film-forming agent. 
     
     
         6 . The orally administered agent according to  claim 5 , wherein said film-forming agent is at least one selected from a group consisting of polyvinyl alcohol, polyvinyl pyrrolidone, hydroxyalkyl cellulose and alkyl cellulose. 
     
     
         7 . The orally administered agent according to  claim 1 , wherein said water-swellable gel-forming layer is formed from a composition that contains a water-swellable gel-forming agent, a film-forming agent and a cross-linking agent. 
     
     
         8 . The orally administered agent according to  claim 7 , wherein said cross-linking agent is a polyvalent metal compound. 
     
     
         9 . The orally administered agent according to  claim 8 , wherein said polyvalent metal compound is at least one selected from a group consisting of calcium chloride, magnesium chloride, aluminum chloride, aluminum sulfate, aluminum potassium sulfate, iron chloride alum, ammonium alum, ferric sulfate, aluminum hydroxide, aluminum silicate, aluminum phosphate, iron citrate, magnesium oxide, calcium oxide, zinc oxide, and zinc sulfate. 
     
     
         10 . The orally administered agent according to  claim 1 , wherein said water-swellable gel-forming layer does not contain a drug. 
     
     
         11 . The orally administered agent according to  claim 1 , wherein the drug is released in stomach or intestine from the orally administered agent after oral administration. 
     
     
         12 . A water-swellable gel-forming film for forming a water-swellable gel-forming layer which covers a drug-containing layer containing a drug to be administered, wherein said water-swellable gel-forming film is formed from a composition comprising a water-swellable gel-forming agent and a film-forming agent. 
     
     
         13 . The water-swellable gel-forming film according to  claim 12 , wherein said water-swellable gel-forming agent is at least one selected from a group consisting of carboxyvinyl polymers, starches and derivatives thereof, agar, alginic acid, arabinogalactan, galactomannan, dextran, pectin, gellan gum and xanthan gum. 
     
     
         14 . The water-swellable gel-forming film according to  claim 12 , wherein said film-forming agent is at least one selected from a group consisting of polyvinyl alcohol, polyvinyl pyrrolidone, hydroxyalkyl cellulose and alkyl cellulose. 
     
     
         15 . The water-swellable gel-forming film according to  claim 12 , wherein said composition further comprises a cross-linking agent. 
     
     
         16 . The water-swellable gel-forming film according to  claim 15 , wherein said cross-linking agent is a polyvalent metal compound. 
     
     
         17 . The water-swellable gel-forming film according to  claim 16 , wherein said polyvalent metal compound is at least one selected from a group consisting of calcium chloride, magnesium chloride, aluminum chloride, aluminum sulfate, aluminum potassium sulfate, iron chloride alum, ammonium alum, ferric sulfate, aluminum hydroxide, aluminum silicate, aluminum phosphate, iron citrate, magnesium oxide, calcium oxide, zinc oxide, and zinc sulfate. 
     
     
         18 . The water-swellable gel-forming film according to  claim 12 , wherein said water-swellable gel-forming film does not contain a drug.