Crystallization Process Development for a Stable Polymorph of Treprostinil Diethanolamine (UT-15C) by Seeding
Organic Process Research & Development2009Vol. 13(2), pp. 242–249
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Hitesh Batra, Raju Penmasta, Kenneth Phares, James P. Staszewski, Sudersan M. Tuladhar, David A. Walsh
Abstract
Process development of treprostinil diethanolamine salt (UT-15C) involved the development of crystallization and slurry protocols to address the polymorph and morphology control issues. Two forms of UT-15C were evaluated by differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD) and thermogravimetric analysis (TGA). Two crystallization solvent systems were developed to produce the thermodynamically stable form in high quality and yield. One solvent system gave dense particles while the other gave lighter and fly-away particles. Slurrying the lighter particles in heptane converted them to denser particles. The protocol was executed successfully on large-scale cGMP batches.
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