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Understanding Powder Behavior in Continuous Feeding: Powder Densification and Screw Layering
| Contributor(s):: Sara Fathollahi, Pauline H. M. Janssen, Bram Bekaert, Dirk Vanderroost, Valerie Vanhoorne, Bastiaan H. J. Dickhoff
Background: Precise continuous feeding of active pharmaceutical ingredients (APIs) and excipients is crucial in a continuous powder-to-tablet manufacturing setup, as any inconsistency can affect the final tablet quality. Method: This study investigated the impact of various materials on the...
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Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing
| 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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Batch vs. continuous direct compression – a comparison of material processability and final tablet quality
| 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
| 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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Effect of batch-to-batch variation of spray dried lactose on the performance of feeders
| Contributor(s):: Carlota Mendez Torrecillas, Florian Tegel, Ralf Weinekötter, Bernhard Meir, Bastiaan H.J. Dickhoff, Sri Sharath Kulkarni, Pauline H.M. Janssen
With the emergence of quality by design (QbD), it becomes imperative to gain understanding of the impact of batch-to-batch variability of raw materials on the performance of processes. Feeding is the first unit of operation in a continuous manufacturing line and is critical for the final product...
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Impact of material properties and process parameters on tablet quality in a continuous direct compression line
| 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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Twin Screw Granulation: Effects of Properties of Primary Powders
| 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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Impact of excipients on batch and continuous powder blending
| 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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Implementation of an online thermal imaging to study the effect of process parameters of roller compactor
| Contributor(s):: Omar, Chalak S., Hounslow, Michael J., Salman, Agba D.
During roller compaction, not only the properties of the primary powder affect the product quality but also the process parameters. Any change in the process parameters during roller compaction will result in changing the properties of the ribbon. In this study, the temperature of the ribbon...