Close search
Scientific papers

Scientific papers

Favorite Articles

    Tags

    Categories

    Authors

    22 results
    Date
    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 …
    no-image

    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 …
    no-image

    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 …
    ME-092-EN-A_Tableting_Rheology_and_Quality_by_D.original

    Tableting rheology and quality by design

    White Papers - 18/01/2023 -
    Quality by Design (QbD) in tablet development can be challenging, due to the multiple competing technological aims, such as flow, compactability, lubrication and drug release. Tablets are complex and, whether …
    no-image

    Usage of compaction simulators for the powder compression characterization – advantages and limitations

    Papers - 26/12/2022 - by Nenad Nikolić, Tijana Miletić, Jovana Kovačević, Djorđe Medarević, Svetlana Ibrić
    Compaction simulators are crafted as machines capable of conducting a thorough analysis of the powder compaction process. The detailed examination of powder compression and compaction, along with material characterization, assumes …
    Commercial scale transfer of a twin-screw melt granulation process for high drug load fevipiprant tablets

    Commercial scale transfer of a twin-screw melt granulation process for high drug load fevipiprant tablets

    Papers - 21/07/2022 - by Claudia Vicente Martin, Stephan Stocker, Manel Bautista, Vincent Rogue, Caroline Steib-Lauer, Hans-Georg Häcker, Dirk Spickermann, Stefan Hirsch, Sundeep S Dhareshwar
    This study provides an overview of specific twin-screw melt granulation techniques and process analytical technology employed in the successful scaling-up and commercial transfer of immediate-release fevipiprant tablets with a high …
    Effect of feed frame on lubricant sensitivity during upscaling from a compaction simulator to a rotary tablet press

    Effect of feed frame on lubricant sensitivity during upscaling from a compaction simulator to a rotary tablet press

    Papers - 25/03/2022 - by Cedrine de Backere, Thomas De Beer, Chris Vervaet, Valérie Vanhoorne
    The incorporation of internal lubrication is often associated with a decline in tabletability, and various factors such as the deformation mechanism, lubricant type, lubricant blending time, and paddle speed (PS) …
    Characterization of tableting speed-dependent deformation properties of active pharmaceutical ingredients in powder mixtures using uut-of-die method

    Characterization of tableting speed-dependent deformation properties of active pharmaceutical ingredients in powder mixtures using uut-of-die method

    Papers - 01/12/2021 - by Daisuke Mizunaga, Mika Koseki, Naoki Kamemoto, Satoru Watano
    This study investigated a quantitative evaluation method to assess the impact of tableting speed on the compression properties of pharmaceutical powders. Cilostazol and ibuprofen served as active pharmaceutical ingredients (APIs), …
    Transfer and scale-up of the manufacturing of orodispersible mini-tablets from a compaction simulator to an industrial rotary tablet press

    Transfer and scale-up of the manufacturing of orodispersible mini-tablets from a compaction simulator to an industrial rotary tablet press

    Papers - 23/07/2021 - by Ard Lura, Valentinë Elezaj, Marcel Kokott, Björn Fischer, Jörg Breitkreutz
    Orodispersible mini-tablets (ODMTs) are emerging as a promising pediatric dosage form, garnering increased attention from the pharmaceutical industry. However, the process of scaling up ODMTs from a compaction simulator to …
    XP 1 - STYL'One Nano - STYL'One Evo

    Tableting scale-up challenges

    White Papers - 15/06/2021 - by Friederike Guetter
    The manufacturing of multilayer tablets may seem to be simple duplications of the basic single-layer compression cycle, but in reality, the process is far more complicated. In this article, KORSCH …
    Roller compaction scale-up made simple: an approximate analytical solution to Johanson's rolling theory

    Roller compaction scale-up made simple: an approximate analytical solution to Johanson's rolling theory

    Papers - 01/05/2020 - by Ricardo Sousa, Pedro Cardoso Valente, Mostaf Nakach, Lionel Bardet, Marie Wacquet, Noel Midoux, Jean-Rene Authelin
    We derive an approximate analytical solution to Johanson's rolling theory, demonstrating that the solution produces a single dimensionless parameter that remains invariant during process scale-up or equipment transfer. This parameter …