Stable multiparticulate pharmaceutical composition of rosuvastatin

Abstract

A stable multi-particulate pharmaceutical composition comprising pellets, the pellets comprising a mixture of rosuvastatin or its pharmaceutically acceptable salts as a sole active ingredient, one or more osmotic release modifiers and one or more stabilizers.

1 . The stable multi-particulate pharmaceutical composition of, wherein an average particle size of the pellets is from about 0.4 mm to 0.8 mm, the rosuvastatin is rosuvastatin calcium, the stabilizer is an alkaline earth metal salt and the osmotic release modifier is an inorganic salt of monovalent cation. 
     
     
         2 . The stable multi-particulate pharmaceutical composition of  claim 1 , wherein the alkaline earth metal salt is magnesium oxide and the inorganic salt of a monovalent cation is sodium citrate. 
     
     
         3 . The stable multi-particulate pharmaceutical composition of  claim 1  prepared by a process comprising: mixing the rosuvastatin or its pharmaceutically acceptable salt, one or more osmotic release modifiers and one or more stabilizers to form granules; extruding the granules; spheronizing the granules; and sizing the granules to have an particle size of from 0.4 mm to 0.8 mm. 
     
     
         4 . A method of treating hyperlipidemia comprising orally administering to a human in need thereof the stable multi-particulate pharmaceutical composition of  claim 1 , wherein the oral administration comprises administration of 5 mg to 40 mg of rosuvastatin per day. 
     
     
         5 . The method of  claim 4 , wherein the oral administration comprises sprinkling the multi-particulate pharmaceutical composition on food. 
     
     
         6 . A stable multi-particulate pharmaceutical composition comprising pellets filled in a capsule sachet or pouch or compressed into a dispersible tablet, the pellets comprising at least 5% by weight of a pharmaceutically acceptable salt of rosuvastatin as a sole active ingredient, by weight of the pellets. 
     
     
         7 . The stable multi-particulate pharmaceutical composition of  claim 6 , comprising 5 to 15% by weight of the pharmaceutically acceptable salt of rosuvastatin as a sole active ingredient, by weight of the pellets. 
     
     
         8 . The stable multi-particulate pharmaceutical composition of  claim 6 , wherein an average particle size of the pellets is from about 0.4 mm to 0.8 mm, the pharmaceutically acceptable salt of rosuvastatin is rosuvastatin calcium, further comprising a stabilizer consisting of an alkaline earth metal salt and an osmotic release modifier consisting of an inorganic salt of a monovalent cation. 
     
     
         9 . The stable multi-particulate pharmaceutical composition of  claim 8 , wherein the alkaline earth metal salt is magnesium oxide and the inorganic salt of a monovalent cation is sodium citrate.