processo para obter forma v da lercanidipine.hcl cristalina, froma v da lercanidipine.hcl cristalina, e, formulação farmacêutica

摘要

The present invention relates to a new process for obtaining crystalline Lercanidipine.HCl Form V. The process includes (i) crystallization from a mixture of iPrOAc and an aprotic polar organic solvent, such as ACN, Me2CO, DMF or DMA or (ii) slurrying Lercanidipine.HCl in iPrOAc. More in details, crystalline Lercanidipine.HCl, preferably Form I, is normally dissolved in DMF or DMA whereas amorphous Lercanidipine.HCl is normally dissolved in ACN or acetone. When Lercanidipine.HCl is slurried in iPrOAc, this is preferably done using amorphous Lercanidipine.HCl.