Continuous twin screw granulation: A complex interplay between formulation properties, process settings and screw design

Portier, Christoph; Pandelaere, K.; Delaet, Urbain; Vígh, Tamás; Pretoro, G. Di; Beer, Thomas De; Vervaet, Chris

doi:10.1016/j.ijpharm.2019.119004

Cited by 47 publications

(35 citation statements)

References 33 publications

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“…In contrast, when granulating the practically insoluble DCP formulation, bond formation within the granules solely resulted from the binder. Similar observations were made by Verstraeten et al and by Portier et al, suggesting that a poorly soluble excipient inhibited the penetration of granulation liquid in the powder bed due to poor wetting, requiring a higher amount of granulation liquid to ensure an optimal powder-liquid interaction [11,29]. As DCP did not contribute to the granulation process, the intrinsic binder effect was more pronounced for the DCP formulation.…”

Section: Binder Selection: Dcp Versus Mannitol Formulationsupporting

confidence: 83%

“…This was attributed to more material dissolving in the granulation liquid, forming more solid bonds upon recrystallization of mannitol during drying [16,30]. A friability threshold of 30% was used to define the granule quality, as above this limit, granules were susceptible to breakage and attrition during downstream operations [11,16,24,26,[35][36][37]. As a binder was considered more efficient when a lower amount of liquid was required to meet the 30% friability limit, the required L/S-ratio to meet this limit was used to distinguish binders on effectiveness.…”

Section: Binder Characterization Technique Abbreviation Characterizatmentioning

confidence: 99%

“…Twin-screw granulation (TSG) has proven its efficacy in continuous solid-dosage manufacturing, as this technique allows continuous production of granules while offering flexibility towards granule properties [8][9][10][11][12][13]. Continuous TSG also requires minimum effort for scale-up, as batch sizes are determined by adjusting the total process time, saving time and costs.…”

Section: Introductionmentioning

confidence: 99%

“…Continuous TSG also requires minimum effort for scale-up, as batch sizes are determined by adjusting the total process time, saving time and costs. Next to the process parameters (e.g., screw speed, material throughput, barrel temperature), product quality is strongly influenced by the formulation variables in TSG [11,14,15]. Binders are often included in the formulation to facilitate the granulation process (e.g., granule nucleation and growth).…”

Section: Introductionmentioning

confidence: 99%

“…Binder effectiveness was defined as the amount of liquid required for binder activation in order to achieve good granule friability (<30%) [16]. As the formulation solubility defines the granulation mechanism [11,29], the binder attributes affecting the granule quality of a highly soluble formulation (mannitol) were examined in the current paper. This formulation was used as a model formulation, limiting the interaction with other possible components in the granulation process, affecting binder performance.…”

Section: Introductionmentioning

confidence: 99%

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Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

et al. 2021

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The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.

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Section: Binder Selection: Dcp Versus Mannitol Formulationsupporting

confidence: 83%

Section: Binder Characterization Technique Abbreviation Characterizatmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

et al. 2021

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Influence of twin-screw elements on dispersion of nano-clay in vinyl ester polymer composites using Taguchi’s orthogonal array technique

Raj,

Tanuja,

Kumar

et al. 2023

Int J Interact Des Manuf

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This work aims to experimentally investigate the influence of screw elements on the dispersion of Cloisite-15A in vinyl ester based on the design of experiments using MINITAB-V16 software. Experiments were designed considering two main factors such as Cloisite-15A loading (1, 2, 3, and 4 wt%) and type of screw elements with a varying number of kneading elements (type 1 with 55 mm, kneading elements and type 2 with 90 mm, kneading elements). The dispersion procedure of Cloisite-15A in vinyl ester was carried out by a combination of both ultrasonication and then twin-screw extrusion. The influence of these factors on the tensile strength and hardness was studied using an experimental layout possessing Taguchi’s L8 Orthogonal Array technique. ANOVA of the experimental results revealed the dispersion of Cloisite-15A with vinyl ester proved to be better when processed with type 2 screw elements having more kneading screws. The S/N ratio study showed that the Cloisite-15A loading had the greatest impact on the type 2 screw's tensile and hardness values for the Cloisite-15A/vinyl ester gel coats when treated at 230 rpm with 10 passes. The probability graphs led to the conclusion that, with a 95% confidence interval, all response values were distributed equally along the normal probability plot's trend. In order to achieve the best response in terms of mechanical strength, the Grey Relational Analysis (GRA) helped identify the best combination of process variables. This combination was known to be 4 wt% Cloisite-15A loading, with type 2 screw processed at 230 rpm with 10 passes. The SEM and XRD showed the absence of agglomeration and better exfoliation of Cloisite-15A in the gel coats with 4 wt% of clay loading.

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Development of prediction model with machine learning in continuous twin screw granulation

Seung-dong

Kim

Han

et al. 2023

J. Pharm. Investig.

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Continuous twin screw granulation: A complex interplay between formulation properties, process settings and screw design

Cited by 47 publications

References 33 publications

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

Influence of twin-screw elements on dispersion of nano-clay in vinyl ester polymer composites using Taguchi’s orthogonal array technique

Development of prediction model with machine learning in continuous twin screw granulation

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