Tamperproof oral dosage form

Abstract

A tamperproof dosage form for oral administration comprising: a caplet comprising first and second ends, a middle region extending between said first and second ends, parallel and oppositely disposed top and bottom faces, and a land interposed between the top and bottom faces and extending along a perimeter of the caplet on a plane parallel to a caplet length axis; and first and second shells, each comprising an open end and a closed dome-shaped end, each fitted over at least a portion of the caplet, the portion comprising at least the first and/or second ends of the caplet and at least part of the middle region. An adhesive substance being arranged between the caplet and the shells at least over a portion of the top and/or bottom faces proximal to the first and second ends of the caplet and a corresponding portion of an inner surface of the closed dome-shaped end of the shells to fixedly join the shells to the caplet.

1 . A tamperproof dosage form for oral administration comprising:
 a caplet comprising first and second ends, a middle region extending between said first and second ends, parallel and oppositely disposed top and bottom faces, and a land interposed between said top and bottom faces and extending along a perimeter of the caplet on a plane parallel to a caplet length axis (X); and   first and second shells, each comprising an open end and a closed dome-shaped end, each fitted over the caplet such that the caplet is fully encapsulated by the first and second shells;   an adhesive substance is arranged between said caplet and said shells at least over a portion of the top and/or bottom faces proximal to the first and second ends of the caplet and a corresponding portion of an inner surface of the closed dome-shaped end of said shells configured to join said shells to said caplet.   
     
     
         2 . A tamperproof dosage form according to  claim 1  wherein the adhesive substance is disposed over an adhesive area, said adhesive area corresponding to an external surface of the caplet comprising at least a portion of the top and/or bottom faces and a portion of the land proximal to the first and second ends of the caplet, wherein said adhesive area is less than the total external surface area of the caplet. 
     
     
         3 . A tamperproof dosage form according to  claim 2  wherein the adhesive area extends substantially continuously over the top and/or bottom faces and the land. 
     
     
         4 . A tamperproof dosage form according to  claim 2  wherein the adhesive region is greater than 5% of the total external surface area of the caplet. 
     
     
         5 . A tamperproof dosage form according to  claim 1  wherein the adhesive substance is radially disposed between the caplet and the first and second shells such to substantially continuously extend parallel to the circumference of the respective shells. 
     
     
         6 . A tamperproof dosage form according to  claim 1  wherein the adhesive substance is disposed between the caplet and substantially the entire inner surface of the dome-shaped end of each first and second shells. 
     
     
         7 . A tamperproof dosage form according to  claim 1  wherein the adhesive substance comprises chitosan, sucrose, fructose, lactose, maltose, cellobiose, glucose, galactose, mannose, arabinose, sorbitol, or mixtures thereof. 
     
     
         8 . (canceled) 
     
     
         9 . A tamperproof dosage form according to  claim 1  wherein the outer surface comprises indicia arranged to provide a tactile and/or visual perception of tamperproofness. 
     
     
         10 . A tamperproof dosage form according to  claim 1  wherein the adhesive substance is comprised in an amount of from 0.6% to 4% by weight of the caplet. 
     
     
         11 . A tamperproof dosage form according to  claim 1  wherein the caplet comprises one or more locking recesses and the first and/or second shells comprise one or more locking protrusions for engagement with respective said locking recesses. 
     
     
         12 . (canceled) 
     
     
         13 . A process of making a tamperproof dosage form comprising the steps of:
 providing a first shell comprising an open end and a closed dome-shaped end;   applying an adhesive substance to said first shell at least on an inner surface of said closed dome-shaped end;   inserting a first end of a caplet through the open end of said first shell;   
       applying an adhesive substance to said caplet on a second end of the caplet opposite said first end, and/or to a second shell a at least on an inner surface of said closed dome-shaped end; and
 inserting a second shell over the second end of said caplet. 
 
     
     
         14 . A process according to  claim 13  wherein a compression force is applied during the insertion steps at a magnitude sufficient to distribute the adhesive substance throughout an interface between substantially the entire closed dome-shaped end of the shells and the caplet. 
     
     
         15 . A tamperproof dosage form according to  claim 1  wherein the caplet is free of subcoatings such that caplet is directly in contact with the adhesive substance. 
     
     
         16 . The tamperproof dosage form of  claim 2  wherein the adhesive region (Ar) is greater than from 15% to 25% of the total external surface area of the caplet. 
     
     
         17 . The tamperproof dosage form of  claim 1  wherein the adhesive substance is free of gelatin. 
     
     
         18 . The tamperproof dosage form of  claim 9  wherein the indicia is in the form of a protrusion and/or a recess.