Spheronisation mechanism of MCC II-based pellets

Krueger, Cornelia; Thommes, Markus; Kleinebudde, Peter

doi:10.1016/j.powtec.2011.12.052

Cited by 24 publications

(9 citation statements)

References 17 publications

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“…In the present study, a longer rotation time led to more spherical particles at a low speed, compared to a shorter time, but this relationship was statistically not significant. The load had no significant effect on the roundness with is in accordance with Krueger et al [42]. However, for a higher load a longer spheronisation time was needed to form round particles [41], which makes an adjustment of the spheroniser speed, time and load indispensable.…”

Section: Resultssupporting

confidence: 73%

“…Low speeds resulted in low interactions and therefore in failure of rounding the particles [41] which is in accordance with the present results, where the particles were still strands or dumbbell-shaped. Other authors also documented a high impact of the spheronisation speed on the roundness of the particles, whereby an increase of spheronisation speed resulted in a higher pellet sphericity [22,39,40,42]. A recent article showed that an initial high-speed spheronisation was required to reduce the extrudates.…”

Section: Resultsmentioning

confidence: 99%

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Modelling the Effect of Process Parameters on the Wet Extrusion and Spheronisation of High-Loaded Nicotinamide Pellets Using a Quality by Design Approach

Theismann

Keppler

Owen³

et al. 2019

Pharmaceutics

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The 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 profile.

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Section: Resultssupporting

confidence: 73%

Section: Resultsmentioning

confidence: 99%

Modelling the Effect of Process Parameters on the Wet Extrusion and Spheronisation of High-Loaded Nicotinamide Pellets Using a Quality by Design Approach

Theismann

Keppler

Owen³

et al. 2019

Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…However, the manufacturing of the MCC II-based formulations is more challenging than for the MCC I-based pellets caused, e.g. by a reduced optimal water content of the wet extrudates and pellets, respectively [4,5]. Furthermore, the disintegration performance is influenced by the storage condition.…”

Section: Introductionmentioning

confidence: 99%

Influence of storage condition on properties of MCC II-based pellets with theophylline-monohydrate

Krueger

Thommes

Kleinebudde

2014

European Journal of Pharmaceutics and Biopharmaceutics

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“…The aspect ratio and porosity were found to decrease during the spheronisation process, whilst the pellet weight and diameter increased during the process. On the contrary, MCC I pellets behaved differently, as their weight remained constant, and the pellets equivalent diameter decreased [52]. Besides, other excipients were evaluated as a substitute for MCC in the extrusion spheronisation, such as for instance chitosan, pectinic acid, polyethylene oxide, HPMC, and k-carrageenan [53].…”

Section: Coated Pellets (Reservoir-type Multiparticulate Drug Delimentioning

confidence: 99%

Oral Modified Release Multiple-Unit Particulate Systems: Compressed Pellets, Microparticles and Nanoparticles

et al. 2018

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Oral modified-release multiparticulate dosage forms, which are also referred to as oral multiple-unit particulate systems, are becoming increasingly popular for oral drug delivery applications. The compaction of polymer-coated multiparticulates into tablets to produce a sustained-release dosage form is preferred over hard gelatin capsules. Moreover, multiparticulate tablets are a promising solution to chronic conditions, patients’ adherence, and swallowing difficulties if incorporated into orodispersible matrices. Nonetheless, the compaction of multiparticulates often damages the functional polymer coat, which results in a rapid release of the drug substance and the subsequent loss of sustained-release properties. This review brings to the forefront key formulation variables that are likely to influence the compaction of coated multiparticulates into sustained-release tablets. It focusses on the tabletting of coated drug-loaded pellets, microparticles, and nanoparticles with a designated section on each. Furthermore, it explores the various approaches that are used to evaluate the compaction behaviour of particulate systems.

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Spheronisation mechanism of MCC II-based pellets

Cited by 24 publications

References 17 publications

Modelling the Effect of Process Parameters on the Wet Extrusion and Spheronisation of High-Loaded Nicotinamide Pellets Using a Quality by Design Approach

Modelling the Effect of Process Parameters on the Wet Extrusion and Spheronisation of High-Loaded Nicotinamide Pellets Using a Quality by Design Approach

Influence of storage condition on properties of MCC II-based pellets with theophylline-monohydrate

Oral Modified Release Multiple-Unit Particulate Systems: Compressed Pellets, Microparticles and Nanoparticles

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