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Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression
Peer-reviewed journal | 20 Nov 2024 | Contributor(s):: Martin Prostredny, Hikaru Graeme Jolliffe, Richard Elkes, Khalid Maqsood, Yunfei Li Song, Gavin Reynolds, Bernhard Meir, John Robertson
Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified...
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Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression
Peer-reviewed journal | 13 Nov 2024 | Contributor(s):: Martin Prostredny, Hikaru Graeme Jolliffe, Richard Elkes, Khalid Maqsood, Yunfei Li Song, Gavin Reynolds, Bernhard Meir, John Robertson
Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified...
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Demonstrating scalability between two blender types using DEM
Peer-reviewed journal | 12 Nov 2024 | Contributor(s):: Peter Boehling, Johan Remmelgas, Mohammadsadegh Salehi, Johannes Poms, Rúben Martins Fraga, Manel Bautista, Johannes G. Khinast, Emmanuela Gavi, Michela Beretta
Powder blending is a critical step in pharmaceutical manufacturing that can impact product quality such as tablet tensile strength. This study utilized the Discrete Element Method (DEM) to investigate blending in a 5-liter mini-batch and a 2-liter Turbula blender. DEM parameters were calibrated...
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Process intensification of pharmaceutical powder blending at commercial throughputs by utilizing semi-continuous mini-blending
Peer-reviewed journal | 13 Aug 2024 | Contributor(s):: Maarten Jaspers, Florian Tegel, Timo P. Roelofs, Fabian Starsich, Yunfei Li Song, Bernhard Meir, Richard Elkes, Bastiaan H.J. Dickhoff
Process intensification involves the miniaturization of equipment while retaining process throughput and performance. The pharmaceutical industry can benefit from this approach especially during drug product development, where the availability of active pharmaceutical ingredients (API) is often...
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Improvement of a pharmaceutical powder mixing process in a tote blender via DEM simulations
Peer-reviewed journal | 04 Jun 2024 | Contributor(s):: Benedict Benque, Luca Orefice, Thomas Forgber, Matthias Habeler, Beate Schmid, Johan Remmelgas, Johannes Khinast
An industrial-scale pharmaceutical powder blending process was studied via discrete element method (DEM) simulations. A DEM model of two active pharmaceutical ingredient (API) components and a combined excipient component was calibrated by matching the simulated response in a dynamic angle of...
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A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction
Peer-reviewed journal | 03 Jun 2024 | Contributor(s):: Hikaru G. Jolliffe, Martin Prostredny, Carlota Mendez Torrecillas, Ecaterina Bordos, Collette Tierney, Ebenezer Ojo, Richard Elkes, Gavin Reynolds, Yunfei Li Song, Bernhard Meir, Sara Fathollahi, John Robertson
Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body...
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New gravimetric dosing device for Continuous Manufacturing
Website | 18 Jan 2024 | Contributor(s):: VX management
"So far, it is mainly Loss in Weight feeders (LIW) that are used for this purpose, especially in the pharmaceutical industry, as they can handle smaller flow rates accurately enough. The mechanical concept of these is decades old and despite miniaturisation and improvements at detail...
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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
Workshop | 20 Nov 2023 | Contributor(s):: Geng Tian
Continuous manufacturing (CM) of drug substances and drug productsProcess modeling and simulation (M&S) for CM at FDACM research highlightsOpportunities of CM for generic drug productsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing -...
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Modeling and simulation of continuous powder blending applied to a continuous direct compression process
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Galbraith, Shaun C., Liu, Huolong, Cha, Bumjoon, Park, Seo-Young, Huang, Zhuangrong, Yoon, Seongkyu
Continuous manufacturing techniques are increasingly being adopted in the pharmaceutical industry and powder blending is a key operation for solid-dosage tablets. A modeling methodology involving axial and radial tanks-in-series flowsheet models is developed to describe the residence time...
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A Systematic Framework for Process Control Design and Risk Analysis in Continuous Pharmaceutical Solid-Dosage Manufacturing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Su, Qinglin, Moreno, Mariana, Giridhar, Arun, Reklaitis, Gintaras, Nagy, Zoltan
The paradigm shift in the pharmaceutical industry to continuous manufacturing, which has recently progressed from conceptual demonstration to pilot production, has stimulated the development and application of process systems engineering (PSE) tools for implementing efficient and robust control...