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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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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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Using a material property library to find surrogate materials for pharmaceutical process development
| Contributor(s):: Escotet-Espinoza, MS, Moghtadernejad, SScicolone, J, Wang, YF, Pereira, G, Schafer, E, Vigh, T, Klingeleers, D, Ierapetritou, M, Muzzio, FJ
Material properties are known to have a significant impact on pharmaceutical manufacturing performance, particularly for solid product processes. Evaluating the performance of a specific material, for example an active pharmaceutical ingredient or excipient, is critical during development stages...
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The Use of Near-Infrared and Microwave Resonance Sensing to Monitor a Continuous Roller Compaction Process
| Contributor(s):: Austin, John, Gupta, Anshu, Mcdonnell, Ryan, Reklaitis, Gintaras V., Harris, Michael T
Roller compaction is commonly used in the pharmaceutical and nutraceutical industries to increase and narrow the size distribution of a particulate material, making it easier to process. Both the moisture content of the material and the density of the roller compacted ribbon affect the uniformity...
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Predicting feeder performance based on material flow properties
| Contributor(s):: Yifan Wang, Benjamin J. Glasser, Fernando J. Muzzio
Purpose: Accurate and consistent delivery of materials by well-designed feeders ensures overall process stability. Importantly, feeding performance is strongly dependent on material flow properties. The purpose of this study is to develop a methodology that identifies predictive correlation...
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In-line monitoring of the drug content of powder mixtures and tablets by near-infrared spectroscopy during the continuous direct compression tableting process
| Contributor(s):: Järvinen, Kristiina, Hoehe, Wolfgang, Järvinen, Maiju, Poutiainen, Sami, Juuti, Mikko, Borchert, Sven
Continuous manufacturing methods offer economic and quality advantages when compared with batch manufacturing methods. In continuous manufacturing, one requires real time assurance of quality of product via the implementation of PAT tools. This study focuses on an in-line near-infrared (NIR)...
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Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation
| Contributor(s):: Harting Julia, Kleinebudde, Peter
Raman spectroscopy was evaluated as a process analytical technology (PAT) tool for continuous API quantification during twin-screw wet granulation. Therefore, a Raman probe was implemented in front of the granulator barrel. This setup enabled the collection of Raman spectra upon a constant...
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Development and applications of a material library for pharmaceutical continuous manufacturing of solid dosage forms
| Contributor(s):: Yifan Wang, ThomasO'Connor, TianyiLi, Muhammad Ashraf
The purpose of this study is to establish a material library and discuss its potential application to the development and lifecycle management of a continuous manufacturing process for solid dosage forms. Particularly, this study addresses the importance of selecting process-relevant testing...
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Continuous quantitative monitoring of powder mixing dynamics by near-infrared spectroscopy
| Contributor(s):: Koller, DM, Posch, A, Horl, G, Voura, C, Radl, S, Urbanetz, N, Fraser, SD, Tritthart, W, Reiter, F, Schlingmann, M, Khinast, JG
FT-NIR spectroscopy with a fiber optical reflection probe was applied as a process analytical technology tool for the continuous quantitative in-line monitoring of pharmaceutical powder mixing processes in a bladed mixer. Two powders, acetyl salicylic acid as an active pharmaceutical ingredient...
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Characterization of material properties
| Contributor(s):: Razavi, Sonia, Oka, Sarang, Escotet-Espinoza, M. Sebastian, Wang, Yifan, Li, Tianyi, Futran Mauricio., Muzzio, Fernando
This chapter describes the importance of deepening our understanding of material properties and their effect on process performance. There are many measurement techniques to describe the complex nature of powders, some of which are provided in this chapter. Strong knowledge of multivariate...
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Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes
| Contributor(s):: Samanta, Asim Kumar, Karande, Atul D., Ng, Ka Yun, Heng, Paul Wan Sia
This study assessed the utility of near-infrared (NIR) spectroscopy for the real-time monitoring of content uniformity and critical quality attributes (tensile strength, Young's modulus, and relative density) of ribbed roller compacted flakes made by axially corrugated or ribbed rolls. A...
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Advances in Continuous Active Pharmaceutical Ingredient (API) Manufacturing: Real-time Monitoring Using Multivariate Tools
| Contributor(s):: Dumarey, Melanie, Hermanto, Martin, Airiau, Christian, Shapland, Peter, Robinson, Hannah, Hamilton, Peter, Berry, Malcom
Purpose: The implementation of continuous processing technologies for pharmaceutical manufacturing has increased due to its potential to enhance supply chain flexibility, reduce the footprint of the manufacturing facility, and deliver more consistent quality. Additionally, it facilitates...