A NOVEL POLYMORPH OF EMTRICITABINE AND A PROCESS FOR PREPARING OF THE SAME

摘要

A polymorph of emtricitabine, wherein said polymorph displays angular positions of characteristic peaks in powder X-ray diffraction pattern 13.61± 0.2, 15.54± 0.2, 19.49± 0.2, 20.55± 0.2, 25.89± 0.2, 28.09± 0.2 and 29.10± 0.2. A pharmaceutical composition comprising a polymorph of emtricitabine displaying angular positions of characteristic peaks in powder X-ray diffraction pattern 13.61± 0.2. 15.54± 0.2. 19.49± 0.2, 20.55± 0.2, 25.89± 0.2, 28.09± 0.2 and 29.10± 0.2. A process for the preparation of a polymorph of emtricitabine comprising the steps of (a) dissolving crude emtricitabine in polar organic solvent by heating at a temperature of at least 40°C and not more than 150°C to form a reaction mixture optionally decreasing the concentration of polar organic solvent in said reaction mixture; cooling the reaction mixture obtained in step (a); and separating the solid from the cooled reaction mixture resulted in step (b).