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Transfer from High-Shear Batch to Continuous Twin Screw Wet Granulation: A Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes
09 Jun 2023 | Contributor(s):: Beer, Paul, Wilson, David, Huang, Zhenyu, De Matas, Marcel
A twin screw to high-shear batch granulation technology switch was evaluated for a pharmaceutical development project. Differences in granule (particle size distribution and porosity) and tablet (dissolution) quality attributes were analysed for both continuous and batch technologies. Liquid to...
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The impact of channel fill level on internal forces during continuous twin screw wet granulation
09 Jun 2023 | Contributor(s):: Torrecillas, Carlota Mendez, Gorringe, Lee J., Rajoub, Nazer, Robertson, John, Elkes, Richard G., Lamprou, Dimitrios A., Halbert, Gavin W
The forces experienced by the particles inside a twin screw granulator (TSG) are one of the most difficult parameters to measure quantitatively. However, it is possible to perform accurately this measurement through the use of dye containing calibrated microencapsulated sensors (LAMES) whose...
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Prediction of quality attributes of continuously produced granules using complementary PAT tools
09 Jun 2023 | Contributor(s):: Fonteyne, Margot, Soares, Sandra, Vercruysse, Jurgen, Peeters, Elisabeth, Burggraeve, Anneleen, Vervaet, Chris, Remon, Jean Paul, Sandler, Niklas, De Beer, Thomas
Manufacturers of pharmaceutical solid dosage forms aim for a reduced production time and a shorter‘‘time-to-market.’’ Therefore, continuous manufacturing gains increasing interest in the pharmaceutical industry. For continuous manufacturing, the quality of produced pharmaceuticals should be...
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Native starch as in situ binder for continuous twin screw wet granulation
09 Jun 2023 | Contributor(s):: Vandevivere, Lise, Portier, Christoph, Vanhoorne, Valerie, Hausler, Olaf, Simon, Denis, De Beer, Thomas, Vervaet, Chris
The use of native starch as in situ binder in a continuous twin screw wet granulation process was studied. Gelatinization of pea starch occurred in the barrel of the granulator using a poorly soluble excipient (anhydrous dicalcium phosphate), but the degree of gelatinization depended on the...
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Influence of granulation temperature on particle size distribution of granules in twin-screw granulation (TSG)
09 Jun 2023 | Contributor(s):: Ito, Akihiko, Kleinebudde, Peter
This study investigated an influence of granulation temperature during twin-screw granulation (TSG) on particle size distributions (PSDs). The influence of the granulation temperature on granule size distributions varied, depending on the liquid to solid (L/S) ratio, the kind of binders, the...
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Fluidization characterization in the ConSigma 25 dryer via process data - A method of advanced quality assurance in continuous manufacturing
09 Jun 2023 | Contributor(s):: Rehrl, Jakob, Hoermann-Kincses, Theresa, Sibanc, Rok, Hsiao, Wen-Kai, Franke, Meik, Khinast, Johannes
Wet granulation lines in pharmaceutical manufacturing facilities typically comprise a dryer that removes the excess moisture content after wet granulation. In this study, a semi-continuous dryer installed in the ConsiGma 25 wet granulation line was investigated. The goal was to highlight specific...
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Continuous twin screw granulation: Influence of process variables on granule and tablet quality
09 Jun 2023 | Contributor(s):: Vercruysse, J., Diaz, D. Cordoba, Peeters, E., Fonteyne, M., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., Veryaet, C.
The aim of the current study was to screen theophylline (125 mg) tablets manufactured via twin screw granulation in order to improve process understanding and knowledge of process variables that determine granule and tablet quality. A premix of theophylline anhydrate, alpha-lactose monohydrate...