Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation

Peeters, Michiel; Jiménez, Ana Alejandra Barrera; Matsunami, Kensaku; Stauffer, F. J.; Beer, Thomas De

doi:10.1016/j.ijpharm.2023.123010

Cited by 7 publications

(6 citation statements)

References 50 publications

(50 reference statements)

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“…Previous reports [ 22 ] have related the extent of granulation to (1) L/S, (2) the relative barrel fill level, estimated in this case by the specific throughput, ST = solid feed rate/screw speed, and (3) the specific mechanical energy, SME = 2π × torque × screw speed/mass flow rate.…”

Section: Resultsmentioning

confidence: 99%

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Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing

Forster,

Dippold,

Haser

et al. 2023

Pharmaceutics

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The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been challenging to move towards continuous processing since traditional equipment has been predominantly strictly batch, instead of readily adapted to material flow such as dry granulation or tablet compression, and there have been few equipment options for continuous granule drying. Recently, pilot and commercial scale equipment combining a twin-screw wet granulator and a novel horizontal vibratory fluid-bed dryer have been developed. This study describes the process space of that equipment and compares the granules produced with batch high-shear and fluid-bed wet granulation processes. The results of this evaluation demonstrate that the equipment works across a range of formulations, effectively granulates and dries, and produces granules of similar or improved quality to batch wet granulation and drying.

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Section: Resultsmentioning

confidence: 99%

“…The QbCon1 granules are expected to be less dense, with more internal porosity [ 24 ]. This formulation shows some impact of TSWG parameters on tabletability, which may be linked to differences in granule internal porosity as well [ 22 ].…”

Section: Resultsmentioning

confidence: 99%

Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing

Forster,

Dippold,

Haser

et al. 2023

Pharmaceutics

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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%

“…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]. For all the experiments, the feed rate was kept constant at 0.8 kg/h, and water was used as the granulation liquid.…”

Section: Granule Preparationmentioning

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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“…At present, the research on CPP in the TSWG process mainly focuses on the geometry and configuration of the screw elements, process variables, and product quality. Different experimental design methods have been performed to evaluate the influence of material properties (formulation, adhesive), process variables (type and number of screw elements, screw speed, liquid feed rate, and liquid to solid (L/S) ratio) on the characteristics of granules [1,[13][14][15][16][17]. Seem et al [18] summarized the comprehensive review of the experimental twin-screw granulator (TSG) literature, indicating the complex interplay between the role of screw element type, screw configuration, feed formulation and liquid flowrates on the granules.…”

Section: Empirical Modelmentioning

confidence: 99%

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Zhao

Tian

2023

Biomedicines

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Twin-screw wet granulation (TSWG) is a method of continuous pharmaceutical manufacturing and a potential alternative method to batch granulation processes. It has attracted more and more interest nowadays due to its high efficiency, robustness, and applications. To improve both the product quality and process efficiency, the process understanding is critical. This article reviews the recent work in process understanding and optimization for TSWG. Various aspects of the progress in TSWG like process model construction, process monitoring method development, and the strategy of process control for TSWG have been thoroughly analyzed and discussed. The process modeling technique including the empirical model, the mechanistic model, and the hybrid model in the TSWG process are presented to increase the knowledge of the granulation process, and the influence of process parameters involved in granulation process on granule properties by experimental study are highlighted. The study analyzed several process monitoring tools and the associated technologies used to monitor granule attributes. In addition, control strategies based on process analytical technology (PAT) are presented as a reference to enhance product quality and ensure the applicability and capability of continuous manufacturing (CM) processes. Furthermore, this article aims to review the current research progress in an effort to make recommendations for further research in process understanding and development of TSWG.

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Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation

Cited by 7 publications

References 50 publications

Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing

Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing

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

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

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