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dc.contributor.authorTheismann, Eva-Maria
dc.contributor.authorKeppler, Julia K
dc.contributor.authorOwen, Martin
dc.contributor.authorSchwarz, Karin
dc.contributor.authorSchlindwein, W. S.
dc.date.accessioned2019-04-18T08:06:25Z
dc.date.available2019-04-18T08:06:25Z
dc.date.issued2019-04-01
dc.identifier.citationTheismann, E-M., Keppler, J. K., Owen, M., Schwarz, K. and Schlindwein, W. (2019) Modelling the Effect of Process Parameters on the Wet Extrusion and Spheronisation of High-Loaded Nicotinamide Pellets Using a Quality by Design Approach, Pharmaceutics 11(4), pp.154en
dc.identifier.issn1999-4923
dc.identifier.urihttps://www.dora.dmu.ac.uk/handle/2086/17720
dc.descriptionOpen access articleen
dc.description.abstractThe aim of the present study was to develop an alternative process to spray granulation in order to prepare high loaded spherical nicotinamide (NAM) pellets by wet extrusion and spheronisation. Therefore, a quality by design approach was implemented to model the effect of the process parameters of the extrusion-spheronisation process on the roundness, roughness and useable yield of the obtained pellets. The obtained results were compared to spray granulated NAM particles regarding their characteristics and their release profile in vitro after the application of an ileocolon targeted shellac coating. The wet extrusion-spheronisation process was able to form highly loaded NAM pellets (80%) with a spherical shape and a high useable yield of about 90%. However, the water content range was rather narrow between 24.7% and 21.3%. The design of experiments (DoE), showed that the spheronisation conditions speed, time and load had a greater impact on the quality attributes of the pellets than the extrusion conditions screw design, screw speed and solid feed rate (hopper speed). The best results were obtained using a low load (15 g) combined with a high rotation speed (900 m/min) and a low time (3–3.5 min). In comparison to spray granulated NAM pellets, the extruded NAM pellets resulted in a higher roughness and a higher useable yield (63% vs. 92%). Finally, the coating and dissolution test showed that the extruded and spheronised pellets are also suitable for a protective coating with an ileocolonic release profile. Due to its lower specific surface area, the required shellac concentration could be reduced while maintaining the release profileen
dc.language.isoenen
dc.publisherMDPIen
dc.subjectwet extrusion-spheronisationen
dc.subjectquality by designen
dc.subjectdesign of experiment (DoE)en
dc.subjectniacinen
dc.subjectcontrolled releaseen
dc.titleModelling the Effect of Process Parameters on the Wet Extrusion and Spheronisation of High-Loaded Nicotinamide Pellets Using a Quality by Design Approachen
dc.typeArticleen
dc.identifier.doihttps://doi.org/10.3390/pharmaceutics11040154
dc.peerreviewedYesen
dc.funderOther external funder (please detail below)en
dc.cclicenceN/Aen
dc.date.acceptance2019-03-25
dc.researchinstituteLeicester Institute for Pharmaceutical Innovation - From Molecules to Practice (LIPI)en
dc.funder.otherThis work was supported by the DFG Cluster of Excellence “Inflammation at Interfaces” (EXC 306). E.-M.T. thanks the scholarship of the “Heinz Wüstenberg-Stiftung” for financial support of the research stay abroad.en


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