Please use this identifier to cite or link to this item: https://doi.org/10.1021/cg2003029
Title: Quality by design (QbD)-based crystallization process development for the polymorphic drug tolbutamide
Authors: Thirunahari, S.
Chow, P.S.
Tan, R.B.H. 
Issue Date: 6-Jul-2011
Citation: Thirunahari, S., Chow, P.S., Tan, R.B.H. (2011-07-06). Quality by design (QbD)-based crystallization process development for the polymorphic drug tolbutamide. Crystal Growth and Design 11 (7) : 3027-3038. ScholarBank@NUS Repository. https://doi.org/10.1021/cg2003029
Abstract: The thermodynamically stable Form II of the antidiabetic drug tolbutamide exhibits a thin fiber needle shape which renders it intractable for isolation and downstream processing. This work implements two in situ process analytical technology (PAT) methods, namely, attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR) with orthogonal partial least-squares- principal component analysis (OPLS-PCA) for monitoring solute concentration, and Raman spectroscopy with dynamic PCA based multivariate statistical process monitoring (MSPM) for detection of solid form purity, to derive the robust design space for cooling crystallization of the desired Form IL. © 2011 American Chemical Society.
Source Title: Crystal Growth and Design
URI: http://scholarbank.nus.edu.sg/handle/10635/89967
ISSN: 15287483
DOI: 10.1021/cg2003029
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