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Twin Screw Granulation: Effects of Properties of Primary Powders
09 Jun 2023 | Contributor(s):: Lute, Sushma, V, Dhenge, Ranjit M., Salman, Agba D.
Lactose and mannitol are some of the most commonly used powders in the pharmaceutical industry. The limited Research Article published so far highlights the effects of process and formulation parameters on the properties of the granules and the tablets produced using these two types of powders...
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Twin-screw granulation and high-shear granulation: The influence of mannitol grade on granule and tablet properties
09 Jun 2023 | Contributor(s):: Megarry, Andrew, Taylor, Agnes, Gholami, Aida, Wikstrom, Hakan, Tajarobi, Pirjo
Granule structure has a key influence on tablet critical quality attributes. The ability to control this structure through excipient choice is an important part of formulation development. Mannitol is a popular diluent and the choice of input grade has been shown to impact granule properties....
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Robust State Estimation of Feeding-Blending Systems in Continuous Pharmaceutical Manufacturing
09 Jun 2023 | Contributor(s):: Liu, Jianfeng, Su, Qinglin, Moreno, Mariana, Laird, Carl, Nagy, Zoltan, Reklaitis, Gintaras
State estimation is a fundamental part of monitoring, control, and real-time optimization in continuous pharmaceutical manufacturing. For nonlinear dynamic systems with hard constraints, moving horizon estimation (MHE) can estimate the current state by solving a well-defined optimization problem...
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Multi-dimensional population balance modeling and experimental validation of continuous powder mixing processes
09 Jun 2023 | Contributor(s):: Sen, Maitraye, Singh, Ravendra Vanarase, Aditya John, Joyce, Ramachandran, Rohit
It has been recognized that the application of quality by design (QbD) to continuous processing in the pharmaceutical industry leads to better process control, improved product quality and mitigates scale-up issues (Schaber et al., 2011), whereby a component of QbD involves the development...
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Mathematical development and comparison of a hybrid PBM-DEM description of a continuous powder mixing process
09 Jun 2023 | Contributor(s):: Sen, Maitraye, Dubey, Atul Singh, Ravendra, Ramachandran, Rohit
This paper describes the development of a multidimensional population balance model (PBM) which can account for the dynamics of a continuous powder mixing/blending process. The PBM can incorporate the important design and process conditions and determine their effects on the various critical...
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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...
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Advanced methodologies for cocrystal synthesis
09 Jun 2023 | Contributor(s):: Douroumis, D, Ross, SA, Nokhodchi, A
Pharmaceutical cocrystals are multicomponent systems composed of two or more molecules and held together by H-bonding. Currently, cocrystals provide exciting opportunities in the pharmaceutical industry for the development and manufacturing of new medicines by improving poor physical properties...
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Achieving continuous manufacturing in lyophilization: Technologies and approaches
09 Jun 2023 | Contributor(s):: Pisano, Roberto, Arsiccio, Andrea, Capozzi, Luigi C., Trout, Bernhardt L.
This paper provides an organic overview of the most interesting continuous freeze-drying concepts that have been proposed over the years. Attention has mainly been focused on the field of pharmaceuticals, but some background has also been given on the food industry. This work aims at providing a...
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A Systematic Framework for the Design and Implementation of Sensing and Control Architecture for a Continuous Pharmaceutical Manufacturing Plant
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Muzzio, Fernando J Ierapetritou, Marianthi, Ramachnadran, Rohit
The continuous pharmaceutical manufacture (CPM) plant and control architecture developed earlier is currently being widely implemented in industries [1,2]. CPM indeed provides an appropriate platform to implement suitable monitoring and control architecture, to improve product quality, and to...