Fast Dissolving Tablet

Abstract

The present invention relates to processes for the preparation of tablets which dissolve rapidly in the mouth and provide an excellent mouthfeel. The tablets of the invention comprise a compound which melts at about 37° C. or lower, have a low hardness, high stability and generally comprise few insoluble disintegrants which may cause a gritty or chalky sensation in the mouth. Convenient and economically feasible processes by which the tablets of the invention may be produced are also provided.

1 .- 14 . (canceled) 
     
     
         15 . A method of producing a tablet composition, which comprises combining an active agent with a fast dissolving granulation, wherein the fast dissolving granulation comprises a low melting point compound and a water soluble excipient. 
     
     
         16 . The method of  claim 15 , which further comprises combining with the active agent and the fast dissolving granulation one or more components selected from the group consisting of a disintegrant, a colorant, a sweetener, a lubricant, a souring agent a glidant, a binder and a flavorant. 
     
     
         17 . The method of  claim 15 , which further comprises molding the tablet composition into a tablet form. 
     
     
         18 . The method of  15 , wherein the fast dissolving granulation is prepared by high sheer granulation. 
     
     
         19 . The method of  claim 18  wherein the low melting point compound is molten. 
     
     
         20 . The method of  claim 19  wherein the fast dissolving granulation is prepared by spraying the molten low melting point compound onto the water soluble excipient and allowing the resulting composition to congeal. 
     
     
         21 . The method of  claim 19  wherein the fast dissolving granulation is prepared by suspending the water soluble excipient in molten low melting point compound and spray congealing the resulting composition. 
     
     
         22 . The method of  claim 19  wherein the tablet composition is made by a method comprising extruding the composition comprising the active agent and the fast dissolving granulation through a nozzle and allowing the resulting composition to congeal. 
     
     
         23 . The method of  claim 19  wherein the water soluble excipient is one or more saccharides selected from the group consisting of maltose, fructose, sucrose, lactose, glucose, galactose, xylitol, sorbitol, and mannitol. 
     
     
         24 . The method of  claim 19  wherein the water soluble excipient is an artificial sweetener. 
     
     
         25 . The method of  claim 19  wherein the water soluble excipient is sucralose. 
     
     
         26 . The method of  claim 19  wherein the low melting point compound is one or more compounds selected from the group consisting of hydrogenated oil, polyethylene glycol, low melting point triglycerides, low melting point diglycerides, low melting point monoglycerides, synthetic glycerides, fatty acid esters, semisynthetic glycerides, partially hydrogenated oil, palm oil, palm butter, wax and cocoa butter. 
     
     
         27 . The method of  claim 19  which comprises congealing a mixture comprising molten low melting point compound and the water soluble excipient. 
     
     
         28 . The method of  claim 27 , which further comprises granulating the congealed mixture by a method selected from the group consisting of sifting the congealed mixture through a screen and milling the congealed mixture. 
     
     
         29 . The method of  claim 28  which further comprises molding the granulated mixture into a tablet shape. 
     
     
         30 . A placebo tablet comprising a low melting point compound that melts or softens at or below 37° C. and a water-soluble excipient. 
     
     
         31 . The tablet of  claim 30  wherein the low melting point compound comprises from about 0.01% to about 2.5% (wt/wt) of the composition and wherein the tablet has a hardness of about 1 to about 2 kP or lower. 
     
     
         32 . A tablet consisting of a fast dissolve granulation, an active ingredient, corn starch, one saccharide selected from the group of sorbitol, glucose, dextrose, fructose, maltose, xylitol, sucrose, lactose, glucose, galactose, mannitol, a dextrate and a maltodextrin, and at least one non-saccharide containing excipient selected from the group consisting of a souring agent, a sweetening agent, crosscarmellose sodium, a flavoring agent a disintegrant, a glidant, and silicon dioxide,
 wherein said fast dissolve granulation consists essentially of some or all of said one saccharide and one or more low melting point compound that melts or softens at or below 37° C.,   wherein the said one or more low melting point compound comprises less than about 20% (wt/wt) of the fast dissolve granulation and from about 0.01% to about 2.5% (wt/wt) of the tablet, and   wherein the tablet has a hardness of less than 1.5 kP.   
     
     
         33 . The tablet of  claim 32  wherein the one saccharide is mannitol. 
     
     
         34 . The tablet of  claim 32  wherein the one or more low melting point compound is one or more compounds selected from the group consisting of hydrogenated oil, and partially hydrogenated oil. 
     
     
         35 . The tablet of  claim 34  wherein the hydrogenated oil or partially hydrogenated oil is a vegetable oil. 
     
     
         36 . A tablet consisting of a fast dissolve granulation, an active ingredient, corn starch, one saccharide selected from the group of sorbitol, glucose, dextrose, fructose, maltose, xylitol, sucrose, lactose, glucose, galactose, mannitol, a dextrate and a maltodextrin, and at least one non-saccharide containing excipient selected from the group consisting of a souring agent, a sweetening agent, crosscarmellose sodium, a flavoring agent a disintegrant, a glidant, and silicon dioxide,
 wherein said fast dissolve granulation consists essentially of said one saccharide and a low melting point compound that melts or softens at or below 37° C. selected from the group consisting of hydrogenated vegetable oil, and partially hydrogenated vegetable oil,   wherein the low melting point compound comprises less than about 20% (wt/wt) of the fast dissolve granulation and from about 0.01% to about 2.5% (wt/wt) of the tablet, and   wherein the tablet has a hardness of less than 1.5 kP.   
     
     
         37 . The tablet of  claim 36  wherein the saccharide is mannitol. 
     
     
         38 .- 40 . (canceled)