This presentation discusses the anti-solvent crystallization of an Active Pharmaceutical Ingredient (API) that was studied with a view to potentially eliminating the need for subsequent micronization. In-process monitoring enabled in-depth process characterization. The mode of anti-solvent addition, and the impact of addition conditions, were investigated.
Particles with a d90 of less than 10μm were generated by rapid addition of solution to well mixed anti-solvent compared to the original process which produced particles with a d90 of approximately 140μm. ParticleTrack with FBRM® technology and PVM® indicated a liquid-phase separation before nucleation because of the rapid supersaturation build-up. The optimized process was successfully scaled-up from 100 mL to 2 L.
The Solid State Pharmaceutical Cluster at the University College Dublin (UCD) has developed expertize in crystal engineering, continuous processing and real-time monitoring of crystallization with in-process particle measurement technology. This webinar highlights their research that has been instrumental to the success of many crystallization projects.
Mairtin McNamara received his PhD from University College Dublin in 2010 studying under Dr. Brian Glennon and is currently a Post Doc Scientist at Janssen Pharmaceutical. His current research is focused on process development with a particular emphasis on crystallization design and characterization using Process Analytical Technologies (PAT).
Presented at the 16th International Process Development Conference, Arosa, Switzerland, 2009