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Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing
Peer-reviewed journal | 13 Aug 2024 | Contributor(s):: Sara Fathollahi, Pauline H. M. Janssen, Bastiaan H. J. Dickhoff, Henderik W. Frijlink
The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of...
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USP Excipients Workshop: Understanding the Impact of Material Attributes on Product Quality for Continuous Manufacturing (On-Demand)
Seminars | 31 Jan 2024 | Contributor(s):: Thomas O’Connor
For continuous manufacturing processes, the impact of variation in material attributes on material feeding and process dynamics should be characterized and appropriate controls implemented if needed.
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Batch vs. continuous direct compression – a comparison of material processability and final tablet quality
Peer-reviewed journal | 03 Jan 2024 | Contributor(s):: S. Fathollahi, D. Vanderroost, T. Roelofs, B.H.J. Dickhoff, C. Vervaet, V. Vanhoorne, B. Bekaert, P.H.M. Janssen
In this study, an in-depth comparison was made between batch and continuous direct compression using similar compression set-ups. The overall material processability and final tablet quality were compared and evaluated. Correlations between material properties, process parameters and final...
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Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting Process
Peer-reviewed journal | 16 Nov 2023 | Contributor(s):: Gerald A. Hebbink, Pauline H. M. Janssen, Jurjen H. Kok, Lorenzo Menarini, Federica Giatti, Caterina Funaro, Salvatore Fabrizio Consoli, Bastiaan H. J. Dickhoff
Modern pharmaceutical manufacturing based on Quality by Design and digitalisation is revolutionising the pharmaceutical industry. Continuous processes are promoted as they increase efficiency and improve quality control. Compared to batch blending, continuous blending is easier to scale and...
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Impact of material properties and process parameters on tablet quality in a continuous direct compression line
Peer-reviewed journal | 09 Aug 2023 | Contributor(s):: Pauline H.M. Janssen, Sara Fathollahi Bram Bekaert, Dirk Vanderroost, Timo Roelofs, Valerie Vanhoorne, Chris Vervaet, Bastiaan H.J. Dickhoff
The current paper shows how excipient properties impact the process parameters and the final tablet properties in a fully integrated continuous direct compression line. Blend properties of low-dose (1% w/w) and high-dose (40% w/w) paracetamol formulations were evaluated...
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Wet Granulation in a Twin-Screw Extruder: Implications of Screw Design
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Thompson, M. R., Sun, J.
Wet granulation in twin-screw extrusion machinery is an attractive technology for the continuous processing of pharmaceuticals. The performance of this machinery is integrally tied to its screw design yet little fundamental knowledge exists in this emerging field for granulation to intelligently...
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Impact of excipients on batch and continuous powder blending
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Jaspers, M, de, Wit, MTWKulkarni, SS, Meir, B, Janssen, PHM, van, Haandel, MMW, Dickhoff, BHJ
Stimulated by Pharma 4.0, the pharmaceutical industry is changing from batch-wise to continuous manufacturing. Therefore, individual processing steps such as blending of the active pharmaceutical ingredient (API) with excipients have to be re-designed to continuous operations. In this study,...
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Fine grade engineered microcrystalline cellulose excipients for direct compaction: Assessing suitability of different dry coating processes
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Chen, Liang, He, Zizhou, Kunnath, Kuriakose, Zheng, Kai, Kim, Sangah, Dave, Rajesh N.
Recent work showed that contrary to conventional wisdom, fine surface engineered excipients outperform their larger counterparts in blends of highly loaded blends of cohesive drug powders in terms of their packing, flowability and tablet tensile strength. Here, two continuous devices, fluid...