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    Evaluation of the effect of granule size of raw tableting materials on critical quality attributes of tablets during the continuous tablet manufacturing process using near-infrared spectroscopy

    Evaluation of the effect of granule size of raw tableting materials on critical quality attributes of tablets during the continuous tablet manufacturing process using near-infrared spectroscopy

    Papers - 17/10/2023 - by Makoto Otsuka, Tokiro Ogata, Yusuke Hattori, Tetsuo Sasaki
    The impact of granule size variation in raw materials on tablet hardness (TH) and weight (TW) within the continuous tablet manufacturing process (CTMP) was explored through the application of near-infrared …
    Comparison of scale-up strategies in twin-screw wet granulation

    Comparison of scale-up strategies in twin-screw wet granulation

    Papers - 25/06/2023 - by Marcel Franke, Thomas Riedel, Robin Meier, Carsten Schmidt, Peter Kleinebudde
    This study aimed to evaluate different scale-up strategies in twin-screw wet granulation and assess their impact on granule and tablet properties for a specific formulation. The granulation process was transitioned …
    Tablets Made from Paper - An Industrially Feasible Approach

    Tablets made from paper - An industrially feasible approach

    Papers - 27/09/2022 - by Ayat Abdelkader, Christoph Moos, Adrien Pelloux, Marcus Pfeiffer, Christian Alter, Stefan Kolling, Cornelia Keck
    Numerous orally administered drugs face challenges in bioavailability due to limited solubility. The smartFilm technology presents an innovative solution for enhancing drug aqueous solubility by incorporating the drug into the …
    The effect of granules characters on mechanical properties of press-coated tablets: A comparative study

    The effect of granules characters on mechanical properties of press-coated tablets: A comparative study

    Papers - 25/08/2022 - by Peifu Xiao, Yibin Guo, Jiahui Wang, Hongbing Liu, JiaXin Zhang, YanJiao Wang, Tian Yin, Yu Zhang, Jingxin Gou, Haibing He, Xing Tang
    The objective of this study was to examine the relationship between crucial granule characteristics (including particle size, surface roughness, and apparent porosity) and the mechanical properties of press-coated tablets. Granules …
    Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process

    Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process

    Papers - 10/03/2021 - by Lise Vandevivere
    The investigation focused on evaluating the appropriateness of pharmaceutical binders for continuous twin-screw wet granulation, reflecting the pharmaceutical industry's shift from batch to continuous manufacturing. A comparison was conducted between …
    Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process

    Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process

    Papers - 03/02/2021 - by Lise Vandevivere, Maxine Vangampelaere, Christoph Portier, Cedrine de Backere, Olaf Häusler, Thomas De Beer, Chris Vervaet, Valérie Vanhoorne
    The appropriateness of pharmaceutical binders for continuous twin-screw wet granulation was examined, aligning with the pharmaceutical industry's transition from batch to continuous manufacturing. A scientific approach to binder selection is …
    Impact of feed material properties on the milling of pharmaceutical ribbons: a PBM analysis

    Impact of feed material properties on the milling of pharmaceutical ribbons: a PBM analysis

    Papers - 30/11/2020 - by Busayo Olaleye, Chuan-Yu Wu, Lian X. Liu
    Dry granulation is a widely employed technique in the pharmaceutical industry for compacting heat and moisture-sensitive feed materials into compacts, followed by subsequent milling. While Population Balance Models (PBMs) are …
    Towards better understanding of the influence of process parameters in roll compaction/ dry granulation on throughput, ribbon microhardness and granule failure load

    Towards better understanding of the influence of process parameters in roll compaction/ dry granulation on throughput, ribbon microhardness and granule failure load

    Papers - 10/11/2020 - by Annika Wilms, Peter Kleinebudde
    A crucial quality aspect of solid oral dosage forms lies in their firmness and capacity to endure breaking or grinding. When aiming for continuous manufacturing, it becomes valuable to assess …
    Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach

    Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach

    Papers - 01/04/2020 - by Yuta Miyazaki, Vincent Lenhart, Peter Kleinebudde
    The objective of this study was to transition from a high shear granulation (HSG) process to a twin-screw granulation (TSG) process while ensuring comparable dissolution profiles. Ibuprofen (IBP) was utilized …
    Simplified end-to-end continuous manufacturing by feeding API suspensions in twin-screw wet granulation

    Simplified end-to-end continuous manufacturing by feeding API suspensions in twin-screw wet granulation

    Papers - 01/12/2018 - by Adrian Schmidt, Hans de Waard, Klaus-Peter Moll, Peter Kleinebudde, Markus Krumme
    This study aimed to explore the integration of continuous manufacturing for drug substance and drug product in an end-to-end continuous manufacturing process. The key step in this integrated approach involved …
    Influence of spray nozzle aperture during high shear wet granulation on granule properties and its compression attributes

    Influence of spray nozzle aperture during high shear wet granulation on granule properties and its compression attributes

    Papers - 01/12/2018 - by Natalia Veronica, Hui Ping Goh, Christina Yong Xin Kang, Celine Valeria Liew, Paul Wan Sia Heng
    The distribution of granulating liquid is acknowledged to influence the high shear wet granulation process, but the impact of spray nozzle attributes remains unclear. While a spray nozzle can achieve …
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    Impact of different dry and wet granulation techniques on granule and tablet properties: a comparative study

    Papers - 01/12/2018 - by Oscar-Rupert Arndt, Roberto Baggio, Anna Kira Adam, Julia Harting, Erica Franceschinis, Peter Kleinebudde
    A comparative analysis was conducted on four granulation techniques to assess their impact on granule properties and tablet tensile strength. A common formulation was selected for processing through wet and …
    Roll compaction and tableting of high loaded Metformin formulations using efficient binders

    Roll compaction and tableting of high loaded Metformin formulations using efficient binders

    Papers - 01/07/2018 - by Oscar-Rupert Arndt, Peter Kleinebudde
    Metformin is known for its poor tabletability and flowability, typically requiring wet granulation with a binder prior to tableting. To enhance cost-effectiveness, there is a desire to implement a roll …
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    Quantitative assessment of mass flow boundaries in continuous twin-screw granulation

    Papers - 14/09/2016 - by Adrian Schmidt, Hans de Waard, Klaus-Peter Moll, Markus Krumme, Peter Kleinebudde
    In the realm of pharmaceutical manufacturing, there is a growing interest in continuous manufacturing. This study focuses on enhancing the comprehension of twin-screw wet granulation as an example of a …
    A combined experimental and modeling approach to study the effects of high-shear wet granulation process parameters on granule characteristics

    A combined experimental and modeling approach to study the effects of high-shear wet granulation process parameters on granule characteristics

    Papers - 01/02/2013 - by Preetanshu Pandey, Jing Tao, Anwesha Chaudhury, Rohit Ramachandran, Julia Z. Gao, Dilbir S. Bindra
    The current study aims to investigate the impact of high-shear wet granulation process parameters on granule characteristics through a combination of experimental and modeling approaches. A full factorial design of …