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    Scaling for Commercialization - Considerations for large-scale API Production

    Scaling for commercialization: considerations for large-scale API production

    Newsfeeds - 04/11/2024 -
    Scaling up from clinical development to larger batch sizes involves numerous challenges and complexities that must be addressed to ensure successful outcomes. Key factors such as risk mitigation, production scalability, …
    Defects in tablet production KORSCH

    Understanding the powder compression phase - and avoiding tablet defects

    White Papers - 14/10/2024 -
    From Vincent Mazel, 19.06.2024The tableting process looks simple, but is complex and irreversible: the University of Bordeaux is learning together with the tableting specialists.Expert in physics and mechanics, highly regarded …
    STYL'One Evo scientist

    STYL’One Evo R&D – Scale-up and production support

    Newsfeeds - 10/07/2024 -
    The STYL’One Evo is a versatile, advanced R&D tablet press designed for use from early API characterization to production support. It is easy to use, clean, and maintain, featuring intuitive …
    Image The Effect of Formulation Variables on the Manufacturability of Clopidogrel Tablets via Fluidized Hot-Melt Granulation

    The effect of formulation variables on the manufacturability of clopidogrel tablets via fluidized hot-melt granulation

    Newsfeeds - 16/05/2024 -
    This study investigates the challenges faced by solid pharmaceutical formulations containing class II active pharmaceutical ingredients (APIs) due to limited solubility, which affects their behavior in the body. Computational tools …
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    Modeling of STYL'One Evolution correction factors for multicomponent mixtures scaling-up to roller compaction

    Papers - 11/04/2024 - by Fabia Arpago, Agostino Dall'Ara
    Roll compaction (RC) stands as a cost-efficient dry granulation technique extensively utilized in the pharmaceutical sector. In the initial stages of formulation development, particularly when resources are constrained, the ability …
    Development of a Semi-Mechanistic Modeling Framework for Wet Bead Milling of Pharmaceutical Nanosuspensions

    Development of a semi-mechanistic modeling framework for wet bead milling of pharmaceutical nanosuspensions

    Papers - 13/03/2024 - by Donald J. Clancy, Gulenay Guner, Sayantan Chattoraj, Helen Yao, M. Connor Faith, Zahra Salahshoor, Kailey N. Martin, Ecevit Bilgili
    The objective of this study was to create a practical semi-mechanistic modeling framework for forecasting particle size changes during the wet bead milling of pharmaceutical nanosuspensions across various process conditions …
    KORSCH Scale-up

    From development phase to serial production

    White Papers - 29/11/2023 - by Johny Bertels
    Scale-up is the last step on the way to commercial tablet production. Once formulation and clinical trial phases have been successfully completed, this final phase involves scaling up to serial …
    Examining the effect of spatial distribution of disintegrant particles on tablet disintegratability

    Examining the effect of spatial distribution of disintegrant particles on tablet disintegratability

    Papers - 09/11/2023 - by Audrey Yi Zheng, Wei Wei Huang, Li Ying Jolene Poon, Eunice Siying Wong, Paul Wan Sia Heng, Lai Wah Chan
    Objective Typically employed at low concentrations in tablets, superdisintegrants may exhibit an uneven spatial distribution within the tablet, leading to varied disintegration times. This study aimed to explore the impact …
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    Scale-up in Twin-screw wet granulation: Impact of formulation properties

    Papers - 27/10/2023 - by Marcel Franke, Thomas Riedel, Robin Meier, Carsten Schmidt, Peter Kleinebudde
    This study aimed to explore the responsiveness of various drug formulations to differences in process parameters based on previously established scale-up strategies. Three distinct formulations were employed for scale-up experiments, …
    Challenges in the Transfer and Scale-Up of Mini-Tableting: Case Study with Losartan Potassium

    Challenges in the transfer and scale-up of mini-tableting: case study with Losartan Potassium

    Papers - 09/10/2023 - by Valentinë Lura, Stefan Klinken, Jörg Breitkreutz
    Mini-tablets (MTs) containing losartan potassium were developed for the treatment of the rare disease Epidermolysis Bullosa. The primary focus was on the transfer and scale-up of a direct compressible formulation …
    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 …
    Swift Single Step Scale up from Compaction Simulator to Production Rotary Press

    Swift single step scale-up from compaction simulator to production rotary press

    Papers - 21/03/2023 - by Moritz Rosch, Friederike Gütter
    The scale up process of tablets can be influenced by many factors that can occur during process development. The development can be highly catalyzed by compaction simulators, which allow for …