Rapidly disintegrating methylcellulose tablets

Abstract

The present invention relates to a novel pharmaceutical composition and process for preparing swallowable methylcellulose tablets that disintegrate rapidly and meet USP standards in 0.1N hydrochloric acid as well as water.

What is claimed is:  
     
         1 . A rapidly disintegrating tablet for oral administration which tablet comprises a compacted mixture of methylcellulose having a viscosity of >1000 centipoise; and an edible calcium salt.  
     
     
         2 . The tablet according to  claim 1  wherein the edible calcium salt is dibasic calcium phosphate dihydrate, calcium phosphate anhydrous, tribasic calcium phosphate; or mixtures thereof.  
     
     
         3 . The tablet according to  claim 1  or  2  which further comprises a binding agent.  
     
     
         4 . The tablet according to  claim 3  wherein the binding agent is PVP, hydroxypropylcellulose, hydroxypropyl methylcellulose, acacia, gelatin, tragacanth, pregelatinized starch or starch.  
     
     
         5 . The tablet according to  claim 4  wherein the binding agent is PVP.  
     
     
         6 . The tablet according to  claim 1  or  2  which further comprises a disintegrating agent.  
     
     
         7 . The tablet according to  claim 6  wherein the disintegrating agent is sodium starch glycolate, sodium carboxymethylcellulose, Ac-di-sol®, carboxymethylcellulose, veegum, alginates, agar, guar, tragacanth, locust bean, karaya, pectin, or crospovidone.  
     
     
         8 . The tablet according to  claim 7  wherein the disintegrating agent is sodium starch glycolate.  
     
     
         9 . The tablet according to  claim 8  wherein the sodium starch glycolate is present in an amount of about 3 to about 8% w/w.  
     
     
         10 . The tablet according to  claim 1  which further comprises a wetting agent.  
     
     
         11 . The tablet according to  claim 10  wherein the wetting agent is sodium lauryl sulfate.  
     
     
         12 . The tablet according to  claim 1  which further comprises a lubricating agent.  
     
     
         13 . The tablet according to  claim 12  wherein the lubricating agent is magnesium stearate.  
     
     
         14 . The tablet according to  claim 1  wherein the methylcellulose has a viscosity of >2000 centipoises.  
     
     
         15 . The tablet according to  claim 14  wherein the methylcellulose has a viscosity of >3000 centipoises.  
     
     
         16 . The tablet according to  claim 15  wherein the methylcellulose has a viscosity of >4000 centipoises.  
     
     
         17 . The tablet according to  claim 1  wherein the methylcellulose is Methocel A4M.  
     
     
         18 . The tablet according to  claim 1  wherein the edible calcium salt is Dibasic calcium phosphate dihydrate and is present in a ratio of methylcellulose to calcium from about 2 to about 4:1.  
     
     
         19 . The tablet according to  claim 1  wherein the edible calcium salt is Calcium phosphate, anhydrous and is present in a ratio of methylcellulose to calcium from about 2 to about 4:1.  
     
     
         20 . The tablet according to  claim 1  wherein the edible calcium salt is Tribasic calcium phosphate and is present in a ratio or methylcellulose to Tribasic calcium phosphate, from about 2 to about 4:1.  
     
     
         21 . The tablet according to  claim 1  which further comprises additional excipents and diluents in the ratio of: 
 Sodium lauryl sulfate:Explotab:Tribasic calcium phosphate:Povidone 29K/32:Magnesium stearate include: 0.40:3.5:21.6:6.4:1.0; or  
 Sodium lauryl sulfate:Explotab:Calcium phosphate, anhydrous:Povidone 29K/32:Magnesium stearate include: 0.40:3.5:21.6:6.4:1.0.  
 
     
     
         22 . The tablet according to  claim 1  or  2  wherein the methylcellulose is present in an amount of about 450 to about 550 mg.  
     
     
         23 . The tablet according to  claim 1  or  2  wherein the methylcellulose is present in an amount of about 200 to about 300 mg.  
     
     
         24 . A rapidly disintegrating tablet for oral administration which tablet comprises methylcellulose having a viscosity of >3000 centipoise; dibasic calcium phosphate, sodium lauryl sulfate, povidone; sodium starch glycolate, and magnesium stearate.  
     
     
         25 . A process for preparing a tablet formulation which comprises compacting a mixture of 
 a) blending together to form an intragranular mixture high viscosity methylcellulose of >3000 cps, a wetting agent, povidone or sodium starch glycolate, and an edible calcium salt; and    b) adding to the mixture of step (a) a PVP aqueous solution, or alternatively spraying the mixture of step (a) with a PVP aqueous solution; and preparing granulates; and    c) blending together an extragranular mixture of an edible calcium salt, a wetting agent; a lubricating agent; povidone or sodium starch glycolate or a mixture thereof; and    d) compacting the granulates of step (b) with the extragranular mixture of step (c).    
     
     
         26 . The process according to  claim 25  wherein the edible calcium salt is dibasic calcium phosphate dihydrate, calcium phosphate anhydrous, tribasic calcium phosphate; or mixtures thereof.  
     
     
         27 . The process according to  claim 26  wherein the edible calcium salt is dibasic calcium phosphate.  
     
     
         28 . A process for the manufacture of a pharmaceutical tablet, which process comprises mixing 
 a) granulates comprising high viscosity methylcellulose of >3000 cps, a wetting agent, povidone or sodium starch glycolate, an edible calcium salt; and    b) blending together an extragranular mixture of an edible calcium salt, a wetting agent; a lubricating agent; povidone or sodium starch glycolate or a mixture thereof; and    c) compacting the granulates of step (b) with the granular mixture of step (a); and    d) compressing into a tablet.