All Categories (1-5 of 5)

1. Systematic investigation of the impact of screw elements in continuous wet granulation

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   Peer-reviewed journal | 10 Sep 2024 | Contributor(s):: Katharina Kiricenko, Peter Kleinebudde, Robin Meier

   Twin-screw wet granulation (TSG) is a continuous manufacturing technique either for granules as final dosage form or as an intermediate before tableting or capsule filling. A comprehensive process understanding is required to implement TSG, considering various parameters influencing granule and...

2. Granulation development in batch-to-batch and continuous processes from a quality by design perspective

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Ko, Seung Jin, Lee, Ju-Hyun, Kang, Chin-Yang, Park, Jun-Bom

   The process of quality by design (QbD) is of great importance in drug development. This review describes the design of experiments (DoE) method, which is an important component of QbD. DoE is predominantly divided into a screening phase and an optimization phase. The screening phase uses...

3. A novel approach to support formulation design on twin screw wet granulation technology: Understanding the impact of overarching excipient properties on drug product quality attributes

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Willecke, N., Szepes, A., Wunderlich, M., Remon, J. P., Vervaet, C., De Beer, T.

   The overall objective of this work is to understand how excipient characteristics influence the drug product quality attributes and process performance of a continuous twin screw wet granulation process. The knowledge gained in this study is intended to be used for Quality by Design (QbD)-based...

4. A Comparison Between Lab-Scale and Hot-Melt-Extruder-Based Anti-inflammatory Ointment Manufacturing

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Thakkar, R, Ashour, EAShukla, A, Wang, R, Chambliss, WG, Bandari, S, Murthy, N, Repka, MA

   Hot-melt extrusion (HME) has been extensively investigated for continuous manufacturing of amorphous solid dispersions, to improve the solubility of poorly water-soluble drug substances, impart abuse deterrence to controlled substances, taste masking for pediatric and geriatric formulations and...

5. A continuous manufacturing concept for a pharmaceutical oral suspension

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Bostijn, N, Van, Renterghem, JDhondt, W, Vervaet, C, De;Beer, T

   The aim of this study was to investigate the applicability of an innovative continuous manufacturing system for semi-solid and liquid pharmaceutical formulations. A commercially available pharmaceutical oral suspension was selected as model formulation. Premixes of the raw materials were dosed...