Method for producing an, in particular oral, active substance laminate, and active substance laminate, in particular oral active substance laminate

Abstract

The invention relates to a method for producing an active substance laminate, especially an oral active substance laminate (100), having at least one active-substance-containing layer (31), which is arranged on a substrate (20), wherein the method comprises the following steps:a) providing a substrate (20) having an upper side (21) and an underside (22);b) applying an active-substance-containing mass (24) in a gap (25) formed by a first rotating roller (26) and a second rotating roller (27);c) transporting the substrate (20) to the second roller (27) by means of a third rotating roller (28) in such a way that the active-substance-containing mass (24) is applied to the upper side (21) of the substrate (20) by the second roller (27) in the form of an active-substance-containing layer (31);d) transporting an intermediate laminate (30), formed by the substrate (20) and the active-substance-containing layer (31), to a drying device (40); ande) drying the intermediate laminate (30), especially the active-substance-containing layer (31).

1 . (canceled) 
     
     
         2 . The active substance laminate according to  claim 13 , characterised in that the substrate is releasably connected, on the underside to a carrier film. 
     
     
         3 . (canceled) 
     
     
         4 . The active substance laminate according to  claim 13 , characterised in that the substrate is free from active substance or contains active substance. 
     
     
         5 . The active substance laminate according to  claim 13 , characterised in that the substrate is formed by at least two active-substance-free layers. 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . An active substance laminate produced by a method comprising:
 a providing a substrate having an upper side and an underside;   b applying an active-substance-containing mass in a gap formed by a first rotating roller and a second rotating roller;   c transporting the substrate to the second roller by means of a third rotating roller in such a way that the active-substance-containing mass is applied to the upper side of the substrate by the second roller in the form of an active-substance-containing layer;   d transporting an intermediate laminate, formed by the substrate and the active-substance-containing layer, to a drying device; and   e drying the intermediate laminate, especially the active-substance-containing layer;   
       wherein the at least one active-substance-containing layer, which is arranged on the substrate, has a constant areal density independently of the thickness and/or the areal density of the substrate. 
     
     
         14 . The active substance laminate according to  claim 13 , characterised in that the substrate is free from active substance or contains active substance. 
     
     
         15 . The active substance laminate according to  claim 13 , characterised in that the active substance of the active-substance-containing layer is an analgesic, fentanyl and/or buprenorphine, optionally present as a base or as a salt, and/or opioid antagonist, or naloxone. 
     
     
         16 . The active substance laminate according to  claim 13 , characterised in that the active-substance-containing layer has an areal density of 40 g/m 2 -100 g/m 2 . 
     
     
         17 . The active substance laminate according to  claim 13 , characterised in that the substrate is formed by one at least two, active-substance-free layer. 
     
     
         18 . The active substance laminate according to  claim 13 , characterised in that the substrate and/or at least one active-substance-free layer are/is formed from a polymer and/or a material that swells upon contact with water and/or a water-soluble material. 
     
     
         19 . The active substance laminate according to  claim 13 , characterised in that the substrate has an areal density of 100 g/m 2 -300 g/m 2 . 
     
     
         20 . The active substance laminate according to  claim 13 , characterised in that two layers which form the substrate each have an areal density of 80 g/m 2 -180 g/m 2 . 
     
     
         21 . The active substance laminate according to  claim 13 , characterised in that a carrier film is formed on the side of the substrate opposite the active-substance-containing layer. 
     
     
         22 . The active substance laminate according to  claim 13 , characterised in that the substrate has an areal density of 240 g/m 2 -280 g/m 2 . 
     
     
         23 . The active substance laminate according to  claim 13 , characterised in that the substrate has an areal density of 250 g/m 2 -270 g/m 2 . 
     
     
         24 . The active substance laminate according to  claim 13 , characterised in that the substrate has an areal density of 262 g/m 2 . 
     
     
         25 . The active substance laminate according to  claim 13 , characterised in that two layers which form the substrate each have an areal density of 100 g/m 2 -160 g/m 2 . 
     
     
         26 . The active substance laminate according to  claim 13 , characterised in that two layers which form the substrate each have an areal density of 120 g/m 2 -140 g/m 2 . 
     
     
         27 . The active substance laminate according to  claim 13 , characterised in that two layers which form the substrate each have an areal density of 131 g/m 2 .