Heat Transfer Evaluation During Twin-Screw Wet Granulation in View of Detailed Process Understanding

Stauffer, F. J.; Ryckaert, Alexander; Hauwermeiren, Daan Van; Funke, Adrian; Djurić, Dejan; Beer, Thomas De

doi:10.1208/s12249-019-1483-z

Cited by 13 publications

(7 citation statements)

References 28 publications

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“…Some studies have been focusing on the influence of process parameters [6,[8][9][10] and formulation properties [11][12][13][14][15][16][17][18] upon granule quality attributes. Other studies targeted a more fundamental understanding of the twin-screw granulation mechanism [7,8,[19][20][21][22][23]. Many of these studies used the granulation module of a continuous from-powder-to-tablet line-the ConsiGma system (GEA Pharma systems, Wommelgem, Belgium) [7][8][9][11][12][13][14]19].…”

Section: Introductionmentioning

confidence: 99%

“…Other studies targeted a more fundamental understanding of the twin-screw granulation mechanism [7,8,[19][20][21][22][23]. Many of these studies used the granulation module of a continuous from-powder-to-tablet line-the ConsiGma system (GEA Pharma systems, Wommelgem, Belgium) [7][8][9][11][12][13][14]19]. The six-segmented fluid bed drying following the granulation unit of the ConsiGma system has been investigated to a lesser extent, although the drying process is crucial to guarantee a good final product.…”

Section: Introductionmentioning

confidence: 99%

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The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

et al. 2021

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The drying unit of a continuous from-powder-to-tablet manufacturing line based on twin-screw granulation (TSG) is a crucial intermediate process step to achieve the desired tablet quality. Understanding the size reduction of pharmaceutical granules before, during, and after the fluid bed drying process is, however, still lacking. A first major goal was to investigate the breakage and attrition phenomena during transport of wet and dry granules, the filling phase, and drying phase on a ConsiGma-25 system (C25). Pneumatic transport of the wet granules after TSG towards the dryer induced extensive breakage, whereas the turbulent filling and drying phase of the drying cells caused rather moderate breakage and attrition. Subsequently, the dry transfer line was responsible for additional extensive breakage and attrition. The second major goal was to compare the influence of drying air temperature and drying time on granule size and moisture content for granules processed with a commercial-scale ConsiGma-25 system and with the R&D-scale ConsiGma-1 (C1) system. Generally, the granule quality obtained after drying with C1 was not predictive for the C25, making it challenging during process development with the C1 to obtain representative granules for the C25.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

et al. 2021

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“…Twin screw granulation (TSG) is an inherently continuous technique offering this flexibility, as it can simply be run for a longer time if more product is required. Already extensive academic research in the TSG field has been performed focusing on the process parameters affecting granulation performance (Djuric and Kleinebudde, 2010;Ito and Kleinebudde, 2019;Kumar et al, 2016;Meier et al, 2017;Stauffer et al, 2019;Vercruysse et al, 2015aVercruysse et al, , 2014Vercruysse et al, , 2012Verstraeten et al, 2017). However, comparison between these studies is hampered as a large diversity of (model) formulations was included.…”

Section: Introductionmentioning

confidence: 99%

The effect of binder types on the breakage and drying behavior of granules in a semi-continuous fluid bed dryer after twin screw wet granulation

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Denduyver

Portier

et al. 2022

International Journal of Pharmaceutics

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“…For twin screw granulation, one important process immanent factor is friction. For good, to facilitate dispersive and distributive mixing [ 1 ], but also for bad in case pronounced abrasion of screw and/or barrel material occurs. To understand and balance the effect of friction, a supportive method should facilitate a more rational selection of equipment and process settings.…”

Section: Introductionmentioning

confidence: 99%

“…Simple conveying elements as well as kneading elements are commonly used screw elements for TSG process [ 21 ]. Stauffer et al already considered a temperature increase along the barrel to be proportional to granulator power consumption and friction forces [ 1 ] in the zones where kneading elements were applied. Kumar et al found an increase of torque with the increasing number of kneading elements being added to the screw [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Assessment of Abrasion-Induced Visual Defects in Twin Screw Wet Granulation Using Wall Friction Measurements

2022

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Starting point of the presented study were abrasion effects occurring during a twin screw wet granulation (TSG) process of a new chemical entity (NCE) formulation, resulting in gray spots on the final tablets. Several actions and systematic changes of equipment and process parameter settings of TSG process were conducted which reduced the visual defect rate of the tablets, i.e., gray spots on the surface, below the specification limit. To understand the rationale and mechanism behind these improvements, correlations of defect rates and wall friction measurements using a Schulze ring shear tester were evaluated. To check the suitability of the method, a broad range of wall materials as well as powder formulations at various moisture levels were investigated with regard to their wall friction angle. As differences in wall friction angle could be detected, further experiments were conducted using wall material samples made out of different screw materials for TSG. Evaluation of these screw wall material samples gave first hints, which screw materials should be preferred in regard of friction for TSG process. In the finally presented case study, wall friction measurements were performed using the above mentioned NCE formulation with known abrasion issues at TSG processing. The results confirmed that changes which led to a reduced visual defect rate of tablets correlated with a decreased wall friction angle. The results suggest wall friction measurements as a potent tool for equipment selection and establishment of a suitable process window prior to conducting TSG experiments. Graphical abstract

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Heat Transfer Evaluation During Twin-Screw Wet Granulation in View of Detailed Process Understanding

Cited by 13 publications

References 28 publications

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

The effect of binder types on the breakage and drying behavior of granules in a semi-continuous fluid bed dryer after twin screw wet granulation

Assessment of Abrasion-Induced Visual Defects in Twin Screw Wet Granulation Using Wall Friction Measurements

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