Process for preparing a soft tablet

Abstract

The invention relates to a process for preparing a soft tablet capable of being chewed or disintegrated in the oral cavity. The tablet is prepared by forming a tablet having a friability of less than about 2% from a mixture comprising a pharmaceutically active ingredient, an excipient in the form of a hydrate, and a water-swellable excipient, and then applying sufficient energy, preferably in the form of heat, to the tablet for a sufficient time to decrease the hardness of the tablet by at least about 20%.

We claim:  
     
         1 . A process for preparing a chewable or disintegrative tablet, comprising forming a tablet having a friability of less than about 2% from a mixture comprising a pharmaceutically active ingredient, an excipient in the form of a hydrate, and a water-swellable excipient, and then applying sufficient energy to the tablet for a sufficient time to decrease the hardness of the tablet by at least about 20%.  
     
     
         2 . The process of  claim 1 , wherein energy is provided to the tablet in the form of heat.  
     
     
         3 . The process of  claim 1 , wherein the tablet is formed by direct compression.  
     
     
         4 . The process of  claim 1  wherein the tablet has a final hardness of less than about 15 kp/cm 2 .  
     
     
         5 . The process of  claim 1 , wherein the friability is less than about 1% and the tablet has a final hardness in the range of about 1-8 kp/cm 2 .  
     
     
         6 . The process of  claim 1 , wherein prior to application of energy to the tablet, the tablet is packaged.  
     
     
         7 . The process of  claim 1 , wherein the active ingredient is selected from the group consisting of acetaminophen, ibuprofen, pseudoephedrine, dextromethorphan, diphenhydramine, chlorpheniramine, calcium carbonate, magnesium hydroxide, magnesium carbonate, magnesium oxide, aluminum hydroxide, mixtures thereof, and pharmaceutically acceptable salts thereof.  
     
     
         8 . The process of  claim 1 , wherein the excipient in the form of a hydrate is selected from the group consisting of dextrose monohydrate, maltodextrin, lactose monohydrate, dextrin, citric acid monohydrate, dibasic calcium phosphate dihydrate, dibasic sodium phosphate dihydrate, dibasic sodium phosphate heptahydrate, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate monohydrate, and monobasic sodium phosphate dihydrate.  
     
     
         9 . The process of  claim 1 , wherein the water-swellable excipient is selected from the group consisting of sodium starch glycolate, crospovidone, croscarmellose, microcrystalline cellulose, starches, and alginic acid.  
     
     
         10 . The process of  claim 1 , wherein the tablet contains about 5 to about 90% by weight of excipient in the form of a hydrate based on the total weight of the tablet.  
     
     
         11 . The process of  claim 1 , wherein the tablet contains about 0.1 to about 5% by weight of water-swellable excipient based on the total weight of the tablet.  
     
     
         12 . The process of  claim 1  wherein the excipient in the form of a hydrate functions as a direct compression filler.  
     
     
         13 . A tablet produced by the process of  claim 1 .  
     
     
         14 . A tablet capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising a) a pharmaceutically active ingredient, b) an excipient at least partially in the form of a hydrate, and c) a water-swellable excipient that is at least partially hydrated.  
     
     
         15 . The tablet of  claim 14 , wherein the active ingredient is selected from the group consisting of acetaminophen, ibuprofen, pseudoephedrine, dextromethorphan, diphenhydramine, chlorpheniramine, calcium carbonate, magnesium hydroxide, magnesium carbonate, magnesium oxide, aluminum hydroxide, mixtures thereof, and pharmaceutically acceptable salts thereof.  
     
     
         16 . The tablet of  claim 14 , wherein the excipient in the form of a hydrate is selected from the group consisting of dextrose monohydrate, maltodextrin, lactose monohydrate, dextrin, citric acid monohydrate, dibasic calcium phosphate dihydrate, dibasic sodium phosphate dihydrate, dibasic sodium phosphate heptahydrate, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate monohydrate, and monobasic sodium phosphate dihydrate.  
     
     
         17 . The tablet of  claim 14 , wherein the water-swellable excipient is selected from the group consisting of sodium starch glycolate, crospovidone, croscarmellose, microcrystalline cellulose, starches, and alginic acid.  
     
     
         18 . The tablet of  claim 14  having a hardness of less than about 15 kp/cm 2 .  
     
     
         19 . A tablet comprising: a) a pharmaceutically active ingredient, b) dextrose monohydrate, and c) crospovidone.  
     
     
         20 . The tablet of  claim 19  having a hardness of less than about 15 kp/cm 2 .  
     
     
         21 . The tablet of  claim 14  which is substantially free of water-soluble, non-saccharide polymeric binders.  
     
     
         22 . The tablet of  claim 14  wherein the excipient that is at least partially hydrated has an average particle diameter of about 100 to about 400 microns.  
     
     
         23 . The tablet of  claim 14  wherein the weight ratio of the excipient in the form of a hydrate to the water-swellable excipient is from about 1:1 to about 150:1.