Manufacture of tablet in a die utilizing powder blend containing water-containing material

Abstract

The present invention features the present invention features a process for making a tablet by compacting a powder blend in a die platen to form a tablet shape, wherein the powder blend includes a pharmaceutically active agent and a water-containing material, and applying energy to the tablet shape for a sufficient period of time to heat the water-containing material within the tablet shape above its dehydration temperature to form the tablet.

1 - 22 . (canceled) 
     
     
         23 . A process for making a tablet comprising introducing a powder blend into a die platen to form a tablet shape, wherein said powder blend comprises a pharmaceutically active agent, a carbohydrate, and a water-containing material, and applying energy to said tablet shape for a sufficient period of time to form said tablet. 
     
     
         24 . A process of  claim 23 , wherein said energy is radiofrequency energy. 
     
     
         25 . The process of  claim 23 , wherein said radiofrequency energy is applied to said tablet shape within said die platen. 
     
     
         26 . The process of  claim 23 , wherein said carbohydrate is selected from the group consisting of dextrose monohydrate, mannitol, erythritol, dextrose, lactose, sorbitol, isomalt, sucrose, and dextrates. 
     
     
         27 . The process of  claim 23 , wherein said carbohydrate is erythritol. 
     
     
         28 . The process of  claim 23 , wherein water is chemically bound to said water-containing material. 
     
     
         29 . The process of  claim 23 , wherein said powder blend is compacted with a force less than 0.3 kiloNewtons. 
     
     
         30 . The process of  claim 23 , wherein said radiofrequency energy has a frequency of from about 1 MHz to 100 MHz. 
     
     
         31 . The process of  claim 23 , wherein said tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds. 
     
     
         32 . The process of  claim 23 , wherein said tablet meets the criteria for orally disintegrating tablets as defined by the draft Food & Drug Administration guidance, as published April, 2007. 
     
     
         33 . The process of  claim 23 , wherein said tablet has a hardness of less than 700 grams as measure using Texture Analyzer TA-XT2i that is fitted with a 7 millimeter diameter flat faced probe. 
     
     
         34 . The process of  claim 23 , wherein said tablet has a density less than 0.7 g/cc. 
     
     
         35 . The process of  claim 23  wherein said process comprises the steps of:
 (i) introducing said powder blend into a forming cavity within said die platen; 
 (ii) by introducing at least one forming tool into said die platen such that a tablet shape is formed; 
 (iii) applying said energy to said tablet shape, within said forming cavity to form said tablet; and 
 (iv) removing said tablet from said forming cavity. 
 
     
     
         36 . The process of  claim 35 , wherein said process further comprises the step of cooling said tablet in said die prior to removing said tablet from said die platen. 
     
     
         37 . The process of  claim 35 , wherein said energy is radiofrequency energy and at least one said forming tool emits said radiofrequency energy to said tablet shape. 
     
     
         38 . The process of  claim 35 , wherein said energy is radiofrequency energy and the die platen emits said radiofrequency energy to said tablet shape. 
     
     
         39 . The process of  claim 35 , wherein said energy is radiofrequency energy and said powder blend is compacted using an upper forming tool and a lower forming tool, and at least one of said upper forming tool or lower forming tool emits said radiofrequency energy to said tablet shape. 
     
     
         40 . The process of  claim 23 , 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. 
     
     
         41 . A tablet manufactured according to the process of  claim 23 . 
     
     
         42 . A tablet of claim  1 , wherein said carbohydrate is erythritol.