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The effect of binder types on the breakage and drying behavior of granules in a semi-continuous fluid bed dryer after twin screw wet granulation
23 Jul 2024 | Contributor(s):: Vandevivere, L., Denduyver, P., Portier, C., Häusler, O., De Beer, T., Vervaet, C., Vanhoorne, V.
Current study investigated the effect of different binder types on the granule drying process and the granule breakage behavior in a semi-continuous fluid bed dryer integrated in the C25 ConsiGma-system. The studied binders (i.e. hydroxypropyl pea starch, hydroxypropyl methylcellulose E15,...
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Development and Application of Control Concepts for Twin-Screw Wet Granulation in the ConsiGmaTM-25: Part 2 Granule Size
Peer-reviewed journal | 04 Jun 2024 | Contributor(s):: Selma Celikovic, Johannes Poms, Johannes Khinast, Martin Horn, Jakob Rehrl
Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of...
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Drying capacity of a continuous vibrated fluid bed dryer – Statistical and mechanistic model development
Peer-reviewed journal | 14 Sep 2023 | Contributor(s):: Johan Remmelgas, Robin Meier, Andreas Altmeyer, Daniel Emanuele, Miika Jormanainen, Anne Juppo, Pirjo Tajarobi, Luis Martin de Juan, Håkan Wikström
The drying capacity of a continuous vibrated fluid bed dryer was studied using a DoE by varying microcrystalline cellulose content in the formulation, water amount in the twin-screw granulation, inlet air temperature, air flow rate and the acceleration of the horizontal fluid-bed....
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Twin Screw Granulation: Effects of Properties of Primary Powders
Peer-reviewed journal | 09 Jun 2023 | 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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Twin-screw granulation and high-shear granulation: The influence of mannitol grade on granule and tablet properties
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Megarry, Andrew, Taylor, Agnes, Gholami, Aida, Wikstrom, Hakan, Tajarobi, Pirjo
Granule structure has a key influence on tablet critical quality attributes. The ability to control this structure through excipient choice is an important part of formulation development. Mannitol is a popular diluent and the choice of input grade has been shown to impact granule properties....
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Parametric Study of Residence Time Distributions and Granulation Kinetics as a Basis for Process Modeling of Twin-Screw Wet Granulation
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Plath, Timo, Korte, Carolin, Sivanesapillai, Rakulan, Weinhart, Thomas
Twin-screw wet granulation is a crucial unit operation in shifting from pharmaceutical batch to continuous processes, but granulation kinetics as well as residence times are yet poorly understood. Experimental findings are highly dependent on screw configuration as well as formulation, and thus...
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Methodology for a Variable Rate Control Strategy Development in Continuous Manufacturing Applied to Twin-screw Wet-Granulation and Continuous Fluid-bed Drying
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Pauli, Victoria, Elbaz, Frantz, Kleinebudde, Peter, Krumme, Markus
Purpose: Continuous manufacturing (CM) promises unrestricted scale up of production volume through runtime, together with lower product quality variability through stricter process control. However, unforeseen incidents that disrupt the process’ steady state or even force temporary shutdown of...
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Integrated twin-screw wet granulation, continuous vibrational fluid drying and milling: A fully continuous powder to granule line
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Fulop, G., Domokos, A., Galata, D., Szabo, E., Gyurkes, M., Szabo, B., Farkas, A., Madarasz, L., Demuth, B., Lender, T., Nagy, T., Kovacs-Kiss, D., Van der Gucht, f, Marosi, G., Nagy, Z. K.
Highly homogeneous low-dose (50 mu g) tablets were produced incorporating perfectly free-flowing granules prepared by a fully integrated Continuous Manufacturing (CM) line. The adopted CM equipment consisted of a Twin-Screw Wet Granulator (TSWG), a Continuous Fluid Bed Dryer (CFBD) and a...
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Faster to First-time-in-Human: Prediction of the liquid solid ratio for continuous wet granulation
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Junnila, A, Wikstrom, HMegarry, A, Gholami, A, Papathanasiou, F, Blomberg, A, Ketolainen, J, Tajarobi, P
In early development, when active pharmaceutical ingredient (API) is in short supply, it would be beneficial to reduce the number of experiments by predicting a suitable L/S ratio before starting the product development. The aim of the study was to decrease development time and the amount of API...
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Continuous twin screw wet granulation: The combined effect of process parameters on residence time, particle size, and granule morphology
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Shirazian, Saeed, Zeglinski, Jacek, Darwish, Shaza, Kuhs, Manuel, Albadarin, Ahmad B., Croker, Denise M., Walker, Gavin M.
In this study, a set of 24 experiments was designed to understand the combined effect of different process parameters, i.e. material feed rate, liquid-to-solid (L/S) ratio, screw speed, and screw configuration on the residence time distribution, granule morphology, and particle size distribution...
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Continuous Single-Step Wet Granulation with Integrated in-Barrel-Drying
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Schmidt, Adrian, de Waard, Hans, Kleinebudde, Peter, Krumme, Markus
Purpose It was investigated if continuous wet granulation and drying could be combined in a twin-screw granulator with the aimto provide (pre-) dried granules in a single-step process, i.e. in-barrel-drying. Methods To have a consistent and robust material propulsionmechanism, a twin-screw...
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Continuous twin screw granulation - An advanced alternative granulation technology for use in the pharmaceutical industry
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Bandari, Suresh, Nyavanandi, Dinesh, Kallakunta, Venkata Raman, Janga, Kartik Yadav, Sarabu, Sandeep, Butreddy, Arun, Repka, Michael A.
Hot melt extrusion has been an exciting technology in the pharmaceutical field owing to its novel applicability. Twin-screw granulation presents a great potential and offers many advantages relative to conventional granulation processes. Different twin-screw granulation techniques, such as...
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Combination of PAT and mechanistic modeling tools in a fully continuous powder to granule line: Rapid and deep process understanding
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Domokos, András, Pusztai, Éva, Madarász, Lajos, Nagy, Brigitta, Gyürkés, Martin, Farkas, Attila (24372641300), Fülöp, Gergő, Casian, Tibor, Szilágyi, Botond., Nagy, Zsombor Kristóf
Comprehensive understanding of an integrated continuous pharmaceutical technology was achieved in this study by a combining design of experiments and mechanistic modeling-based simulations. The powder to granule line consisted of twin-screw wet granulation, vibrational fluid-bed drying and...
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Assessment of spatial heterogeneity in continuous twin screw wet granulation process using three-compartmental population balance model
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Liu, Huolong, Galbraith, Shaun C., Park, Seo-Young, Cha, Bumjoon, Huang, Zhuangrong, Meyer, Robert Frederick, Flamm, Matthew H., O'Connor, Thomas, Lee, Sau, Yoon, Seongkyu
In this study, a novel three-compartmental population balance model (PBM) for a continuous twin screw wet granulation process is developed, combining the techniques of PBM and regression process modeling. The developed model links screw configuration, screw speed, and blend throughput with...
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A scaled down method for identifying the optimum range of L/S ratio in twin screw wet granulation using a regime map approach
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Pradhan, Shankali U., Bullard, Joseph W., Dale, Steven, Ojakovo, Peter, Bonnassieux, Alexandre
Twin screw wet granulation (TSWG) has gained momentum in the pharmaceutical industry for effective continuous granulation of solid dosage products. Liquid-to-solid (L/S) ratio is a key process parameter affecting granule properties. Identifying an optimum range of L/S ratio while reducing the...
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A review of twin screw wet granulation mechanisms in relation to granule attributes
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Zhang, Yi, Liu, Tongzhou, Kashani-Rahimi, Shahab, Zhang, Feng
Due to the trend of continuous pharmaceutical manufacturing, twin screw wet granulation (TSWG), a continuous process, has gained increased Research Article interest as a potential substitution of traditional batch granulation processes. Despite the complex nature of TSWG, its mechanisms have been...