MULTI-LAYERED ORALLY DISINTEGRATING TABLET AND THE MANUFACTURE THEREOF
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.
1 . A tablet comprising a first layer and a second layer, wherein:
(i) said first layer comprises a pharmaceutically active agent and the composition of said first layer is different from the composition of said second layer;
(ii) said tablet has a density less than about 0.8 g/cc; and
(iii) said tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.
2 . The tablet of claim 1 , wherein said second layer comprises a pharmaceutically active agent.
3 . The tablet of claim 2 , wherein said first layer does not comprise the same pharmaceutically active agent as said second layer.
4 . The tablet of claim 1 , wherein said first layer disintegrates at least two times faster then said second layer.
5 . The tablet of claim 1 , wherein the color of said first layer is different from the color of said second layer.
6 . The tablet of claim 1 , wherein the flavor of said first layer is different from the flavor of said second layer.
7 . The tablet of claim 1 , wherein said tablet comprises a third layer, wherein the composition of said third layer is different from the composition of said first layer and said second layer.
9 . The tablet of claim 1 , wherein said tablet meets the criteria for orally disintegrating tablets as defined by the draft Food & Drug Administration guidance, as published April, 2007.
10 . The tablet of claim 1 , wherein said tablet has a density less than about 0.7 g/cc.
11 . The tablet of claim 1 , wherein said binder comprises polyethylene glycol having an average particle size of less than about 100 microns.
12 . The tablet of claim 1 , wherein said tablet comprises less than about 1 percent, by weight, of superdisintegrant.
13 . 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;
compacting a first powder blend and a second powder blend in said die platen to form a tablet shape; and
applying energy to said 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.
14 . The process of claim 13 , 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.
15 . The process of claim 13 , 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.
16 . The process of claim 13 , 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 comprised within said first powder blend.
17 . The process of claim 13 , 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.
18 . The process of claim 13 , wherein said first powder blend comprises particles comprising said first pharmaceutically active agent wherein said particles are coated with said binder.
19 . The process of claim 13 , wherein said process comprises compacting said first powder blend prior to adding said second powder blend to said die platen.
20 . The process of claim 13 , 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.