Method for producing orally administrable edible agent of aggregated substance-containing laminate film form and orally administrable edible agent of aggregated substance-containing laminate film form

Abstract

In pressure bonding edible layers having irregular surfaces due to the presence of aggregated substance so that the irregular surfaces face each other, an edible layer substantially free of any aggregated substance is interposed therebetween. This allows an orally administrable edible agent of aggregated substance-containing laminate film form having a multilayer structure including laminated extremely thin layers to be produced. The multilayer structure by such a pressure bonding technique can satisfy quantitative accuracy required for pharmaceutical preparations, and prevents time constraint in a drying step or the like, thereby providing a producing method with high productivity.

1 - 13 . (canceled) 
     
     
         14 . An orally administrable edible agent of aggregated substance-containing laminate film form characterized in that an edible layer substantially free of any aggregated substance is interposed between two edible layers containing an aggregated substance. 
     
     
         15 . The orally administrable edible agent of aggregated substance-containing laminate film form according to  claim 14 , characterized in that said aggregated substance is an active ingredient having a physiological activity. 
     
     
         16 . The orally administrable edible agent of aggregated substance-containing laminate film form according to  claim 14 , characterized in that at least one of the edible layers containing said aggregated substance and the edible layer substantially free of any aggregated substance contain an edible thermoplastic substance. 
     
     
         17 . The orally administrable edible agent of aggregated substance-containing laminate film form according to  claim 16 , characterized in that said edible thermoplastic substance includes at least one selected from the group consisting of amylose, carboxymethyl cellulose potassium, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, alkyl ester alginate, sodium alginate, ethyl cellulose, eudragit, carboxymethylethylcellulose, carboxymethyl starch, carboxymethyl cellulose, agar, gelatin, shellac, dextran, dextrin, starch, tragacanth, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose phthalate, polyvinylpyrrolidone, methacrylic acid copolymer, and methylcellulose phthalate. 
     
     
         18 . The orally administrable edible agent of aggregated substance-containing laminate film form according to  claim 14 , characterized in that at least one of the edible layers containing said aggregated substance and the edible layer substantially free of any aggregated substance contain an edible non-thermoplastic substance and an edible thermoplasticity adding substance.