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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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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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Native starch as in situ binder for continuous twin screw wet granulation
| Contributor(s):: Vandevivere, Lise, Portier, Christoph, Vanhoorne, Valerie, Hausler, Olaf, Simon, Denis, De Beer, Thomas, Vervaet, Chris
The use of native starch as in situ binder in a continuous twin screw wet granulation process was studied. Gelatinization of pea starch occurred in the barrel of the granulator using a poorly soluble excipient (anhydrous dicalcium phosphate), but the degree of gelatinization depended on the...
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Mixing Cell: a Device to Mimic Extent of Lubrication and Shear in Continuous Tubular Blenders
| Contributor(s):: Moghtadernejad, S, Escotet-Espinoz, AMS, Liu, ZJ, Schafer, E, Muzzio, F
Continuous manufacturing (CM) has clear potential for manufacturing solid oral dosages. It provides several advantages that may aid the manufacturing and quality of drug products. However, one of the main challenges of this technology is the relatively large amount of knowledge required and the...
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Loss-in-weight feeding, powder flow and electrostatic evaluation for direct compression hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing
| Contributor(s):: Allenspach, Carl, Timmins, Peter, Lumay, Geoffroy, Holman, James, Minko, Tamara
Minimizing variability in the feeding process is important for continuous manufacturing since materials are fed individually and can impact the final product. This study demonstrates the importance of measuring powder properties and highlights the need to characterize the feeding performance both...
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Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition
| Contributor(s):: Vandevivere, L., Denduyver, P., Portier, C., Hausler, O., De Beer, T., Vervaet, C., Vanhoorne, V.
The effect of a wide variety of binders on the quality of granules produced via continuous twin screw wet granulation was studied. Anhydrous dicalcium phosphate was used as poorly soluble filler and was granulated applying dry or wet addition of binders. Furthermore, dry and wet binder...
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Impact of Vertical Blender Unit Parameters on Subsequent Process Parameters and Tablet Properties in a Continuous Direct Compression Line
| Contributor(s):: Kreiser, MJ, Wabel, C, Wagner, KG
The continuous manufacturing of solid oral-dosage forms represents an emerging technology among the pharmaceutical industry, where several process steps are combined in one production line. As all mixture components, including the lubricant (magnesium stearate), are passing simultaneously through...
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Impact of blend properties and process variables on the blending performance
| Contributor(s):: Bekaert, B, Grymonpre, W, Novikova, A, Vervaet, C, Vanhoorne, V
In this study, quantitative relationships were established between blend properties, process settings and blending responses via multivariate data-analysis. Four divergent binary blends were composed in three different ratios and processed at various throughputs and impeller speeds. Additionally,...
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Feeding of particle-based materials in continuous solid dosage manufacturing: a material science perspective
| Contributor(s):: Hsiao, WK, Hormann, TR, Toson, P, Paudel, A, Ghiotti, P, Stauffer, F, Bauer, F, Lakio, S, Behrend, O, Maurer, R, Holman, J, Khinast, J
The pharmaceutical industry today is experiencing a paradigm shift from batch to continuous manufacturing, which promises greater flexibility to target diverse populations, as well as more-consistent product quality to ensure best efficacy. However, shifting to continuous processing means that...
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Direct compaction properties of Zingiberis Rhizoma extracted powders coated with various shell materials: Improvements and mechanism analysis
| Contributor(s):: Li, Zhe, Zhou, Miaomiao, Wu, Fei, Shen, Lan, Lin, Xiao, Feng, Yi
Direct compaction (DC) attracts more and more attention for tablet manufacturing; however, its application in natural plant product (NPP) tablets is still extremely limited. In this study, 8 kinds of composite particles (CPs) based on the Zingiberis Rhizoma extracted powder (ZR) (a natural plant...
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Continuous twin screw granulation: Impact of microcrystalline cellulose batch-to-batch variability during granulation and drying - A QbD approach
| Contributor(s):: Portier, Christoph, Vigh, Tamas, Di Pretoro, Giustino, Leys, Jan, Klingeleers, Didier, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
Despite significant advances in the Research Article domain of continuous twin screw granulation, limited information is currently available on the impact of raw material properties, especially considering batch-to-batch variability. The importance of raw material variability and subsequent...
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Continuous twin screw extrusion for the wet granulation of lactose
| Contributor(s):: Keleb, EI, Vermeire, A, Vervaet, C, Remon, JP
The Suitability of continuous twin screw extrusion for the wet granulation of a-lactose monohydrate was studied and compared with conventional high shear granulation. The influence of process parameters (screw speed and total input rate) and formulation variables (water and polyvinylpyrrolidone...
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Cellulose Ethers for Extrusion Applications
| Contributor(s):: Pinto, Elanor, Duerig, Thomas
Cellulose ethers have been used for years in developing oral dosage forms via batch processes such as direct compression and wet granulation. Recent advances in continuous manufacturing have brought about innovative technologies such as hot melt extrusion, melt extrusion granulation, and...
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A quality by design approach to investigate the effect of mannitol and dicalcium phosphate qualities on roll compaction
| Contributor(s):: Souihi, Nabil, Dumarey, Melanie, Wikstrom, Hakan, Tajarobi, Pirjo, Fransson, Magnus, Svensson, Olof, Josefson, Mats, Trygg, Johan
Roll compaction is a continuous process for solid dosage form manufacturing increasingly popular within pharmaceutical industry. Although roll compaction has become an established technique for dry granulation, the influence of material properties is still not fully understood. In this study, a...
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A multivariate approach to predict the volumetric and gravimetric feeding behavior of a low feed rate feeder based on raw material properties
| Contributor(s):: Bostijn, N, Dhondt, J, Ryckaert, A, Szabo, E, Dhondt, W, Van Snick, B, Vanhoorne, V, Vervaet, C, De Beer, T
In this study, the volumetric and gravimetric feeding behavior of 15 pharmaceutical powders on a low feed rate feeder was correlated with their material properties through a multivariate approach. The powders under investigation differ substantially in terms of material properties, making the...
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A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry powder processes
| Contributor(s):: Van;Snick, B, Dhondt, JPandelaere, K, Bertels, J, Mertens, R, Klingeleers, D, Di, Pretoro, G, Remon, JP, Vervaet, C, De, Beer, T, Vanhoorne, V
In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100...