Formulations of Ramipril

Abstract

The present invention relates to stable tablet formulations of ramipril, optionally in combination with a diuretic.

1 . A tablet formulation comprising:
 a) 0.5-5.0% w/w of ramipril;   b) 50-95% w/w of calcium sulphate dihydrate; and   c) 0.1-5.0% W/w of sodium hydrogen carbonate,   
       optionally in combination with a disintegrant, binder and lubricant and other excipients. 
     
     
         2 . The tablet formulation of  claim 1 , wherein the calcium sulphate dihydrate is Compactrol. 
     
     
         3 . The tablet formulation of  claim 1  or  claim 2 , additionally in combination with a diuretic. 
     
     
         4 . The tablet formulation of  claim 3 , wherein the diuretic is hydrochlorothiazide. 
     
     
         5 . The tablet formulation of  claim 3 , wherein the diuretic is piretanide. 
     
     
         6 . The tablet formulation of any of  claims 1  to  5 , wherein the disintegrant and binder is pregelatinised starch. 
     
     
         7 . The tablet formulation of any of  claims 1  to  6 , wherein the lubricant is sodium stearyl fumarate. 
     
     
         8 . The tablet formulation of  claim 1  or  claim 2  containing 1.25 mg ramipril, wherein the amount of ramipril is 0.5-1.5% w/w, the amount of Compactrol is 85-90% w/w, the amount of sodium hydrogen carbonate is 0.5-1.5% w/w, the amount of starch pregelatinised is 7-13% w/w and the amount of sodium stearyl fumarate is 0.5-1.5% w/w. 
     
     
         9 . The tablet formulation of  claim 1  or  claim 2  containing 2.5 mg, 5 mg or 10 mg ramipril, wherein the amount of ramipril is 1.4-2.5% w/w, the amount of Compactrol is 78-95% w/w, the amount of sodium hydrogen carbonate is 1.4-2.5% w/w, the amount of starch pregelatinised is 7-13% w/w and the amount of sodium stearyl fumarate is 0.5-1.5% w/w. 
     
     
         10 . The tablet formulation of any of  claims 1  to  4 , containing 2.5 mg ramipril/2.5 mg hydrochlorothiazide or 5 mg ramipril/25 mg hydrochlorothiazide, wherein the amount of ramipril is 1.4-2.5% w/w, the amount of hydrochlorothiazide is 8.5-10.5% w/w, the amount of Compactrol is 65-75% w/w, the amount of sodium hydrogen carbonate is 1.0-2.5% w/w, the amount of starch pregelatinised is 12-18% w/w and the amount of sodium stearyl fumarate is 0.5-1.5% w/w. 
     
     
         11 . The tablet formulation of any of  claims 1  to  3  and  5 , containing 5 mg ramipril and 6 mg piretanide, the preferred amount of ramipril is 1.5-2.5% w/w, the amount of piretanide is 1.8-3.0% w/w, the amount of Compactrol is 65-85% w/w, the amount of sodium hydrogen carbonate is 3.0-5.0% w/w, the amount of starch pregelatinised is 10-20% w/w and the amount of sodium stearyl fumarate is 0.5-1.5% w/w.