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 - 31 . (canceled) 
     
     
         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 sowing agent, a sweetening agent, crosscarmellose sodium, a flavoring agent, a disintegrant, a glidant and a 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 0.5 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 a 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 0.5 kP.   
     
     
         37 . The tablet of  claim 36  wherein the saccharide is mannitol. 
     
     
         38 .- 40 . (canceled)