4TH International Congress on Technology - Engineering & SCIENCE - Kuala Lumpur - Malaysia (2017-08-05)

Study Of The Anti-solvent Process For Indomethacin-saccharin Co-crystallization Based On In-line Monitoring Systems
On a basis of the pharmaceutical process validation guidance issued in 2011 by US FDA, in-line monitoring technologies and/or systems for critical pharmaceutical processes have become very important especially such as crystallization. In this study, two in-line monitoring tools, FBRM (focused beam reflectance measurement) and PVM (particle vision measurement) were employed to investigate the behavior of a co-crystallization between indomethacin(IMC) and saccharin(SAC) via anti-solvent addition approach. The injection rate of anti-solvent, in this study water, was examined as a primary process variable. Resulting crystalline materials were adequately processed and characterized using the XRD (x-ray diffraction) and DSC (differential scanning calorimetry). It was found that the pathway of co-crystal formation was significantly dependent upon the addition rate of water. Hence, FBRM and PVM appear to be very valuable in interpreting and understanding the pharmaceutical co-crystallization process as in-line monitoring tools. Detailed experimental procedures and data shall be presented for extensive discussion in the poster session.
Paul Kim, Min-yong Cho, Guang-Jin Choi