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Extrusion-sphéronisation de produits pharmaceutiques : comparaison et transposition à échelle industrielle de procédés d’extrusion par plans d’expériences

Abstract : Among the various methods of developing minigranules, extrusion-spheronization has many advantages, particularly since it allows to develop minigranules highly charged with active pharmaceutical ingredient and to avoid the use of organic solvents. This work aims to compare the performance of several extrusion screws systems, from the lab to the scale-up at industrial scale. Designs of experiments were built to identify critical variables and compare the extruder in terms of different approaches specific to this study. As a matter of fact, the ideal extrusion system is defined in this work as the one which gives the best results in terms of productivity and pellets characteristics (“quality”), the one which shows less impact on the product after scaling-up (“scalability”), the one which shows the less influence on these same properties when the formula used changes (“robustness”), and the one which allows the possibility to adjust or improve pellets properties with operating variables (“flexibility”). Whatever the approach studied, the results allowed to highlight the influence of critical parameters and their interactions on the different responses and showed differences between the different extrusion systems. The study at lab scale compared radial, dome and axial extruders and underlined the interest of axial and dome systems in terms of pellets quality, and radial system in terms of process robustness and flexibility. The study at industrial scale compared radial and axial systems, and identified the axial system as the most favorable in terms of pellets quality , robustness, flexibility and scalability. The conclusions observed at industrial scale are different from those observed at lab scale for the different systems comparative study. This confirms the importance to test systems at industrial scale before investing in one equipment.
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https://tel.archives-ouvertes.fr/tel-00685210
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Submitted on : Wednesday, April 4, 2012 - 3:01:13 PM
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  • HAL Id : tel-00685210, version 1

Citation

Amélie Désire. Extrusion-sphéronisation de produits pharmaceutiques : comparaison et transposition à échelle industrielle de procédés d’extrusion par plans d’expériences. Médecine humaine et pathologie. Université Paris Sud - Paris XI, 2011. Français. ⟨NNT : 2011PA114816⟩. ⟨tel-00685210⟩

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