NDLI: NIR diffuse reflectance for on-scale monitoring of the polymorphic form transformation of pazopanib hydrochloride (GW786034); model development and method transfer

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NIR diffuse reflectance for on-scale monitoring of the polymorphic form transformation of pazopanib hydrochloride (GW786034); model development and method transfer

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NIR diffuse reflectance for on-scale monitoring of the polymorphic form transformation of pazopanib hydrochloride (GW786034); model development and method transfer

Content Provider	Royal Society of Chemistry (RSC)
Author	Ng, Patrick Coleman, Jo Ann Rydzak, James Barnes, Susan E. Ertl, Darryl Thurston, Thomas Diederich, Ann Bhanushali, Dharmesh Bakeev, Katherine
Copyright Year	2010
Abstract	We report the successful application of in situ diffuse reflectance near-infrared (NIR) spectroscopy for characterization of the solvent mediated polymorphic form transformation of pazopanib hydrochloride. Crystal form is a critical quality attribute (CQA) for this active pharmaceutical ingredient (API) to ensure appropriate levels of exposure in patients. NIR spectroscopy was implemented to monitor this final stage unit operation in real-time on manufacturing scale. This technique provided an automated in situ method to replace labour intensive off-line qualitative testing and manual sampling. A partial least squares (PLS) model was created using NIR data collected during an early manufacturing campaign and a novel strategy based on interval-PLS was used to select and optimize the model parameters. The model was subsequently implemented on plant scale and used to monitor clinical manufacturing campaigns. The PLS method clearly differentiated between the monohydrate and the desired anhydrous form allowing determination of the transformation end point in real-time. Utilisation of PLS diagnostics such as Mahalanobis distance and spectral residuals provided additional capability to signal any unexpected behaviour in the process and/or indicate the presence of an undesired solvate polymorph also seen during process development.
Starting Page	1890
Ending Page	1899
Page Count	10
File Format	HTM / HTML PDF
ISSN	17599660
Volume Number	2
Issue Number	12
Journal	Analytical Methods
DOI	10.1039/c0ay00376j
Language	English
Publisher	Royal Society of Chemistry
Access Restriction	Open
Subject Keyword	Spectroscopy NIR Active ingredient Unit operation Solvent Pazopanib Mahalanobis distance Shapeshifting
Content Type	Text
Resource Type	Article
Subject	Analytical Chemistry Engineering Chemical Engineering

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3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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