Merck Sharp + Dohme Corp.

Christopher Wahl

Benjamin Cohen

Aaron S Cote

Itzia Arroyo

A thermodynamically controlled process for preparing Form I polymorph of lamivudine is described, wherein the process involves crystallizing Form I at a temperature of from about 0&#xb0; C. to about 50&#xb0; C. from a mixture which comprises (a) lamivudine or an acid salt thereof or both, (b) a solvent system comprising water and at least one organic solvent, and optionally (c) Form I seed; wherein, when a lamivudine acid salt is employed in the mixture, the crystallizing step is conducted in the presence of a base; and wherein the water activity of the solvent system is maintained in a range in which Form I is thermodynamically the most stable form of lamivudine.

Growing community of inventors

Philadelphia, PA, United States of America

Christopher Wahl