MANUFACTURE OF TABLET IN A DIE UTILIZING POWDER BLEND CONTAINING WATER-CONTAINING MATERIAL
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.