2014 AIChE Annual Meeting

(460c) Applications of Process Analytical Technologies in the Solid State Development of Pharmaceutical Compounds

Authors

Bing-Shiou Yang - Presenter, Boehringer Ingelheim Pharmaceuticals, Inc.
Zhibin Li, Boehringer Ingelheim Pharmaceuticals, Inc.
Soojin Kim, Boehringer Ingelheim Pharmaceuticals, Inc.
Ashish Citroda, Boehringer Ingelheim
Nathan Yee, Boehringer Ingelheim Pharmaceuticals, Inc.
Chris Senanayake, Boehringer Ingelheim Pharmaceuticals, Inc.

In the recent years, process analytical technology (PAT) has been proven to be very useful on the pharmaceutical development and manufacturing for better process understanding and control. For example, the information of the in-situ particle size distribution by Lasentec ® FBRM is invaluable on the crystallization development and scale-up. This paper discussed some less common but very important PAT application cases on the solid-state development of pharmaceutical compounds, for example, 1) the use of on-line mass spectrometer to monitor the form conversion of a de-solvated solid form, 2) the use of the combination of IR and Raman to construct the phase diagram for the crystallization development of pharmaceutical co-crystals, 3) crystallization control using FTIR or Raman in the solvent swap crystallization.