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.

What is claimed: 
     
         1 . A tablet comprising a low melting point compound that melts or softens at or below 37° C. a water soluble excipient and an active ingredient, wherein the low melting point compound comprises from about 0.01% to about 2.5% (wt/wt) of the tablet, and wherein the tablet has a hardness of about 2.0 or lower. 
     
     
         2 . The tablet of  claim 1 , wherein the water soluble excipient comprises about 25% to about 97.3% (wt/wt) of the tablet. 
     
     
         3 . The tablet of  claim 1  wherein the water soluble excipient comprises about 40% to about 85% (wt/wt) of the tablet. 
     
     
         4 . The tablet of  claim 1  wherein the water soluble excipient is a saccharide. 
     
     
         5 . The tablet of  claim 4  wherein the saccharide is one or more substance selected from the group consisting of maltose, fructose, sucrose, lactose, glucose, galactose, xylitol, sorbitol, dextrates, maltodextrins and mannitol. 
     
     
         6 . The tablet of  claim 1  wherein the water soluble excipient is sucralose. 
     
     
         7 . The tablet of  claim 1  wherein the water soluble excipient is aspartame. 
     
     
         8 . The tablet of  claim 1  further comprising one or more components selected from the group consisting of a disintegrant, a colorant, a sweetener, a souring agent, a glidant, a binder, a lubricant and a flavorant. 
     
     
         9 . The tablet of  claim 1  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. 
     
     
         10 . The tablet of  claim 9  wherein the hydrogenated oil or partially hydrogenated oil is a vegetable oil. 
     
     
         11 . The tablet of  claim 9  wherein the low melting point compound comprises a mixture of a low melting point monoglyceride, a low melting point diglyceride and a low melting point triglyceride. 
     
     
         12 . The tablet of  claim 9  wherein the low melting point compound is a partially hydrogenated oil and wherein the partially hydrogenated oil is one or more substances selected from the group consisting of partially hydrogenated palm kern oil and partially hydrogenated cotton seed oil. 
     
     
         13 . The tablet of  claim 9  wherein the hydrogenated oil is a hydrogenated vegetable oil. 
     
     
         14 . The tablet of  claim 9  wherein the low melting point compound is a fatty acid ester and the fatty acid ester is one or more compounds selected from the group consisting of stearic acid ester, palmitic acid ester and myristyl lactate ester. 
     
     
         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 extending 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 sitting 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.