Multi-layered orally disintegrating tablet and the manufacture thereof

Abstract

The present invention features a tablet containing a first layer and a second layer, wherein: (i) the first layer includes a pharmaceutically active agent and the composition of the first layer is different from the composition of the second layer; (ii) the tablet has a density less than about 0.8 g/cc; and (iii) the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.

What is claimed is: 
     
         1 . A process for making a tablet comprising a first layer and a second layer, said method comprising:
 adding a first powder blend to a die platen, wherein said first powder blend comprises a pharmaceutically active agent and a binder;   adding a second powder blend to said die platen, wherein said second powder blend comprises a binder and wherein the composition of said second powder blend is different from the composition of said first powder blend;   tamping said first powder blend and second powder blend in said die platen to form a tamped tablet shape; and   applying energy to said tamped tablet shape for a sufficient period of time to activate said binders within said tablet shape to fuse said tablet shape into said tablet such that said tablet has a density less than about 0.8 g/cc and said tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.   
     
     
         2 . The process of  claim 1 , wherein said binder within said first powder blend and said binder within said second powder blend are meltable materials having a melting point of from about 30° C. to about 140° C. and said tablet shape is exposed to said energy for a sufficient period of time to melt or soften said binders. 
     
     
         3 . The process of  claim 1 , wherein said binder within said first powder blend is a RF-meltable binder, and said tablet shape is exposed to RF energy for a sufficient period of time to melt or soften said RF-meltable binder. 
     
     
         4 . The process of  claim 1 , wherein said first powder blend comprises a RF-heatable material, and said tablet shape is exposed to RF energy for a sufficient period of time to heat said RF-heatable material such that said RF-heatable material melts or softens said binder within said first powder blend. 
     
     
         5 . The process of  claim 1 , wherein said binder within said first powder blend and said binder within said second powder blend are water-activating binding materials, said first powder blend and said second powder blend further comprise water-containing materials, and said tablet shape is exposed to said energy for a sufficient period of time to heat the water-containing materials above their dehydration temperature. 
     
     
         6 . The process of  claim 1 , wherein said first powder blend comprises particles comprising said first pharmaceutically active agent wherein said particles are coated with said binder. 
     
     
         7 . The process of  claim 1 , wherein said process further comprises tamping said first powder blend prior to adding said second powder blend to said die platen. 
     
     
         8 . The process of  claim 1 , wherein the surface of said tablet is further exposed to infrared energy wherein the majority of the wavelength of said infrared energy from about 0.5 to about 5 micrometers. 
     
     
         9 . The process of  claim 1  wherein said tamping step comprises tamping at a pressure of less than about 1000 pounds per square inch. 
     
     
         10 . The process of  claim 1  wherein said tamping of said first powder blend is done at a pressure of less than about 1000 pounds per square inch prior to adding said second powder blend.