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Use of near-infrared spectroscopy to quantify drug content on a continuous blending process: Influence of mass flow and rotation speed variations
09 Jun 2023 | Contributor(s):: Martínez, Lizbeth, Peinado, Antonio, Liesum, Lorenz, Betz, Gabriele
The aim of this study was to develop a quantitative Near-Infrared (NIR) method which monitors the homogeneity of a pharmaceutical formulation coming out of a continuous blender. For this purpose, a NIR diode array spectrometer with fast data acquisition was selected. Additionally, the dynamic...
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Sampling optimization for blend monitoring of a low dose formulation in a tablet press feed frame using spatially resolved near-infrared spectroscopy
09 Jun 2023 | Contributor(s):: Román-Ospino, Andrés, Baranwal, Yukteshwar, Li, Jingzhe, Vargas, Jenny, Igne, Benoît, Bate, Simon, Brouckaert, Davinia, Chauchard, Fabien, Hausner, Douglas, Ramachandran, Rohit, Singh, Ravendra, Muzzio, Fernando
In-line measurements of low dose blends in the feed frame of a tablet press were performed for API concentration levels as low as 0.10% w/w. The proposed methodology utilizes the advanced sampling capabilities of a Spatially Resolved Near-Infrared (SR-NIR) probe to develop Partial Least-Squares...
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Development of calibration-free/minimal calibration wavelength selection for iterative optimization technology algorithms toward process analytical technology application
09 Jun 2023 | Contributor(s):: Rish, AJJ, Henson, Samuel R., Anik Alam, Md., Liu, Yang, Drennen, James K., Anderson, Carl A
As continuous manufacturing (CM) processes are developed, process analytical technology (PAT) via NIR spectroscopy has become an integral tool in process monitoring. NIR spectroscopy requires the deployment of complex multivariate models to extract the relevant information. The model of choice...
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Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process
09 Jun 2023 | Contributor(s):: Román-Ospino, Andrés D, Tamrakar, Ashutosh Igne, Benoît Dimaso, Elyse Towns Airiau, Christian Clancy, Donald J Pereira, Glinka Muzzio, Fernando J Singh, Ravendra, Ramachandran, Rohit
This work describes the characterization of three NIR interfaces intended to monitor a continuous granulation process. Two interfaces (i.e. a barrel interface and a rotating paddle interface) were evaluated to monitor the API concentration at the entrance of the granulator, and a third interface...