Optimization of a Crystallization Process for Orantinib Active Pharmaceutical Ingredient by Design of Experiment To Control Residual Solvent Amount and Particle Size Distribution

2015 ◽  
Vol 19 (11) ◽  
pp. 1655-1661 ◽  
Author(s):  
Hiroyasu Sato ◽  
Shotaro Watanabe ◽  
Daisuke Takeda ◽  
Shingo Yano ◽  
Norihito Doki ◽  
...  
Processes ◽  
2019 ◽  
Vol 7 (6) ◽  
pp. 355
Author(s):  
Tamar Rosenbaum ◽  
Li Tan ◽  
Joshua Engstrom

Active pharmaceutical ingredient (API) particle size distribution is important for both downstream processing operations and in vivo performance. Crystallization process parameters and reactor configuration are important in controlling API particle size distribution (PSD). Given the large number of parameters and the scale-dependence of many parameters, it can be difficult to design a scalable crystallization process that delivers a target PSD. Population balance modeling is a useful tool for understanding crystallization kinetics, which are primarily scale-independent, predicting PSD, and studying the impact of process parameters on PSD. Although population balance modeling (PBM) does have certain limitations, such as scale dependency of secondary nucleation, and is currently limited in commercial software packages to one particle dimension, which has difficulty in predicting PSD for high aspect ratio morphologies, there is still much to be gained from applying PBM in API crystallization processes.


2020 ◽  
Vol 69 (4) ◽  
pp. 102-106
Author(s):  
Shota Ohki ◽  
Shingo Mineta ◽  
Mamoru Mizunuma ◽  
Soichi Oka ◽  
Masayuki Tsuda

1995 ◽  
Vol 5 (1) ◽  
pp. 75-87 ◽  
Author(s):  
Christine M. Woodall ◽  
James E. Peters ◽  
Richard O. Buckius

1998 ◽  
Vol 84 (5) ◽  
pp. 387-392 ◽  
Author(s):  
Takashi INOUE ◽  
Yuzo HOSOI ◽  
Koe NAKAJIMA ◽  
Hiroyuki TAKENAKA ◽  
Tomonori HANYUDA

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