461101 API Particle Formation: Technological Approaches to Forming Unique API Characteristics

Tuesday, November 15, 2016: 12:35 PM
Cyril Magnin III (Parc 55 San Francisco)
Jessica Whelan, School of Chemical and Bioprocess Engineering, University College Dublin, Dublin 4, Ireland, Mark Barrett, APC Ltd, Dublin 4, Ireland and Brian Glennon, School of Chemical and Bioprocess Engineering, UCD, Dublin, Ireland

The formation of highly differentiated APIs to enable specific downstream filtration, drying and drug product performance, in terms of flowability, blending, content uniformity and in vitro disintegration and dissolution is becoming an ever important feature in pharmaceutical process design.

Within this presentation the application of technological platforms, such as continuous processing, hybrid batch/continuous wet milling enabled system, will be discussed in detail. A series of case studies will show the work flow and design details associated to engineering and population balance models, reactor design, supersaturation monitoring / control to enable the delivery of highly differentiated API particle characteristics. The interface between the drug substance and drug product will be discussed at length to demonstrate the ability of engineering strategies to enable predictable downstream process performance.

Extended Abstract: File Not Uploaded
See more of this Session: Crystallization Process Development II
See more of this Group/Topical: Separations Division