Hydrophobic/hydrophilic powders: Practical implications of screw element type on the reduction of fines in twin screw granulation

Mundozah, Aquino L.; Cartwright, J.; Tridon, Claire C.; Hounslow, Michael J.; Salman, Agba D.

doi:10.1016/j.powtec.2018.03.018

Cited by 14 publications

(6 citation statements)

References 19 publications

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“…It has been shown in the literature that a hydrophobic powder requires the usage of a large L / S ratio for robust granule growth [ 57 ]. Moreover, Mundozah et al [ 69 ] showed that a stagger angle of 60 degree was unhelpful to promote liquid solid mixing and granule growth for such formulations. Hence, under such conditions small extent of growth can be expected, as seen in the case of Meier et al’s study [ 36 ] ( Figure 8 ).This confirms our finding that the conditions employed by Meier et al [ 36 ] leads to a nucleation and crumb type of growth in the TSG ( Figure 7 ).…”

Section: Resultsmentioning

confidence: 99%

“…Vercruysse et al [ 35 ] used a mixture of Theophylline and Lactose as their input material, which are both hydrophilic. Robust granulation of hydrophilic components can be achieved in a TSG at very low L / S ratio [ 70 , 71 , 72 ], especially in the presence of kneading elements [ 69 ]. Moreover, Vercruysse et al [ 35 ] also used PVP as a binder which increased the relative density of the liquid binder close to 100, while keeping the L / S ratio constant at 0.09, Vercruysse et al [ 35 ] varied the number of kneading elements, stagger angle, screw speed and feed rate between 2 & 12, 30 & 90, 600 & 950, and 10 & 25, respectively.…”

Section: Resultsmentioning

confidence: 99%

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Development of a Granule Growth Regime Map for Twin Screw Wet Granulation Process via Data Imputation Techniques

2022

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Twin screw granulation (TSG) is a continuous wet granulation technique that is used widely across different solid manufacturing industries. The TSG has been recognized to have numerous advantages due to its modular design and continuous manufacturing capabilities, including processing a wide range of formulations. However, it is still not widely employed at the commercial scale because of the lack of holistic understanding of the process. This study addresses that problem via. the mechanistic development of a regime map that considers the complex interactions between process, material, and design parameters, which together affect the final granule quality. The advantage of this regime map is that it describes a more widely applicable quantitative technique that can predict the granule growth behavior in a TSG. To develop a robust regime map, a database of various input parameters along with the resultant final granule quality attributes was created using previously published literature experiments. Missing data for several quality attributes was imputed using various data completion techniques while maintaining physical significance. Mechanistically relevant non-dimensional X and Y axis that quantify the physical phenomena occurring during the granulation were developed to improve the applicability and predictability of the regime map. The developed regime map was studied based on process outcomes and granule quality attributes to identify and create regime boundaries for different granule growth regimes. In doing so breakage-dominant growth was incorporated into the regime map, which is very important for TSG. The developed regime map was able to accurately explain the granule growth regimes for more than 90% of the studied experimental points. These experimental were generated at vastly different material, design, and process parameters across various studies in the literature, this further increases the confidence in the developed regime map.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Development of a Granule Growth Regime Map for Twin Screw Wet Granulation Process via Data Imputation Techniques

2022

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“…For all scenarios, the model could accurately capture the location of the peaks. Furthermore, the model is able to capture the shifts in the resulting distribution in each compartment due to the applied shear and compression forces inside the kneading block and the redistribution of liquid binder within the powder [ 8 , 31 , 32 ].…”

Section: Resultsmentioning

confidence: 99%

Improvement of a 1D Population Balance Model for Twin-Screw Wet Granulation by Using Identifiability Analysis

et al. 2021

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Recently, the pharmaceutical industry has undergone changes in the production of solid oral dosages from traditional inefficient and expensive batch production to continuous manufacturing. The latest advancements include increased use of continuous twin-screw wet granulation and application of advanced modeling tools such as Population Balance Models (PBMs). However, improved understanding of the physical process within the granulator and improvement of current population balance models are necessary for the continuous production process to be successful in practice. In this study, an existing compartmental one-dimensional PBM of a twin-screw granulation process was improved by altering the original aggregation kernel in the wetting zone as a result of an identifiability analysis. In addition, a strategy was successfully applied to reduce the number of model parameters to be calibrated in both the wetting zone and kneading zones. It was found that the new aggregation kernel in the wetting zone is capable of reproducing the particle size distribution that is experimentally observed at different process conditions as well as different types of formulations, varying in hydrophilicity and API concentration. Finally, it was observed that model parameters could be linked not only to the material properties but also to the liquid to solid ratio, paving the way to create a generic PBM to predict the particle size distribution of a new formulation.

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“…The variation range of each factor is shown in Table 2 . The use of such an experimental design to gain of a mechanistic understanding of wet granulation processes has been commonly used in literature [ 12 , 14 , 23 , 24 , 25 , 26 , 27 , 28 ].…”

Section: Methodsmentioning

confidence: 99%

Investigating the Effects of Mixing Dynamics on Twin-Screw Granule Quality Attributes via the Development of a Physics-Based Process Map

Kotamarthy,

Karkala,

Dan

et al. 2024

Pharmaceutics

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Twin-screw granulation (TSG) is an emerging continuous wet granulation technique that has not been widely applied in the industry due to a poor mechanistic understanding of the process. This study focuses on improving this mechanistic understanding by analyzing the effects of the mixing dynamics on the granule quality attributes (PSD, content uniformity, and microstructure). Mixing is an important dynamic process that simultaneously occurs along with the granulation rate mechanisms during the wet granulation process. An improved mechanistic understanding was achieved by identifying and quantifying the physically relevant intermediate parameters that affect the mixing dynamics in TSG, and then their effects on the granule attributes were analyzed by investigating their effects on the granulation rate mechanisms. The fill level, granule liquid saturation, extent of nucleation, and powder wettability were found to be the key physically relevant intermediate parameters that affect the mixing inside the twin-screw granulator. An improved geometrical model for the fill level was developed and validated against existing experimental data. Finally, a process map was developed to depict the effects of mixing on the temporal and spatial evolution of the materials inside the twin-screw granulator. This process map illustrates the mechanism of nucleation and the growth of the granules based on the fundamental material properties of the primary powders (solubility and wettability), liquid binders (viscosity), and mixing dynamics present in the system. Furthermore, it was shown that the process map can be used to predict the granule product quality based on the granule growth mechanism.

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Hydrophobic/hydrophilic powders: Practical implications of screw element type on the reduction of fines in twin screw granulation

Cited by 14 publications

References 19 publications

Development of a Granule Growth Regime Map for Twin Screw Wet Granulation Process via Data Imputation Techniques

Development of a Granule Growth Regime Map for Twin Screw Wet Granulation Process via Data Imputation Techniques

Improvement of a 1D Population Balance Model for Twin-Screw Wet Granulation by Using Identifiability Analysis

Investigating the Effects of Mixing Dynamics on Twin-Screw Granule Quality Attributes via the Development of a Physics-Based Process Map

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