Pharmaceutical compositions of linezolid

Abstract

The present invention relates to stable pharmaceutical compositions comprising linezolid crystalline Form III with one or more pharmaceutically acceptable excipients, wherein the composition retains linezolid in its original crystalline form.

What is claimed is: 
     
         1 . A stable pharmaceutical composition comprising linezolid Form III and polacrilin potassium as disintegrant, prepared by a dry granulation process, wherein the composition retains linezolid in its original Form III crystalline form. 
     
     
         2 . The stable pharmaceutical composition of  claim 1 , further comprising hydroxypropylmethyl cellulose as a binder. 
     
     
         3 . The stable pharmaceutical composition of  claim 1 , further comprising a pharmaceutically acceptable excipient selected from a diluent, a binder, a glidant, a lubricant, a disintegrant, stabilizer, and mixtures thereof. 
     
     
         4 . The stable pharmaceutical composition of  claim 3 , wherein the binder is selected from hydroxypropylmethyl cellulose, polyvinylpyrrolidone k-30, hydroxypropyl cellulose (low-substituted), starch, and mixtures thereof. 
     
     
         5 . The stable pharmaceutical composition of  claim 3 , wherein the diluent is selected from mannitol, sorbitol, xylitol, lactose monohydrate, microcrystalline cellulose, magnesium carbonate, dicalcium phosphate, tribasic calcium phosphate, and mixtures thereof. 
     
     
         6 . The stable pharmaceutical composition of  claim 3 , wherein the lubricant is selected from magnesium stearate, zinc stearate, calcium stearate, sodium stearyl fumarate, stearic acid, and mixtures thereof. 
     
     
         7 . The stable pharmaceutical composition of  claim 1 , comprising 60% to 90% w/w of linezolid Form III, 1% to 30% w/w of lactose monohydrate, 0.3% to 20% w/w of hydroxypropylmethyl cellulose, 0.2% to 8% w/w of polacrilin potassium, and 0.5% to 5% w/w of magnesium stearate. 
     
     
         8 . The stable pharmaceutical composition of  claim 1 , in the form of an oral solid dosage forms selected from a tablet, a caplet, a pellet, a capsule, granules, a pill, powder, and a sachet.