Distribution of binder in granules produced by means of twin screw granulation

Fonteyne, Margot; Fussell, A.L.; Vercruysse, Jurgen; Vervaet, Chris; Remon, Jean Paul; Strachan, Clare J.; Rades, Thomas; Beer, Thomas De

doi:10.1016/j.ijpharm.2013.12.008

Cited by 21 publications

(5 citation statements)

References 9 publications

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“…The authors reported increasing liquid heterogeneity with more hydrophobic formulations, and the composition of their particles was found to be increasingly hydrophilic (i.e., greater lactose content) as granule size increased. This finding of the binder being poorly distributed matched the results of others who noted a higher binder content present in larger granules when the dropwise/injection method of binder delivery is employed Fonteyne et al, 2014;Vercruysse et al, 2014). Conversely, it has been noted in studies with a high shear batch mixer that unlike droplet wetting, aspects of nucleation related to liquid penetration show very little dependency on the hydrophobicity of a powder mixture when employing foam granulation.…”

Section: Introductionsupporting

confidence: 82%

“…Common processing variables such as extruder screw speed, feed rate, liquid-to-solid ratio, binder concentration, and binder viscosity have been well studied and summarized in a recent review of the technology (Thompson, 2015). However, binder spreading and ingredient mixing has only recently been considered for twin screw granulators (El Hagrasy and Litster, 2013a,b;Fonteyne et al, 2014;Kumar et al, 2014;Vercruysse et al, 2014;Yu et al, 2014). The studies that have examined mixing within the machine to date have been based on wetting by liquid injection and noted significant heterogeneity.…”

Section: Introductionmentioning

confidence: 99%

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Examining drug hydrophobicity in continuous wet granulation within a twin screw extruder

Thompson

O’Donnell

2015

International Journal of Pharmaceutics

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Section: Introductionsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Examining drug hydrophobicity in continuous wet granulation within a twin screw extruder

Thompson

O’Donnell

2015

International Journal of Pharmaceutics

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“…Many studies have shown that the impeller speed and the L/S ratio are two of the most important TSG process parameters affecting the quality of the granules. [41][42][43][44] Therefore, a full factorial design of experimentation (DoE) technique varying these two parameters at four levels was performed (Table 3). The screw configuration comprised of 2 large-spaced conveying elements (L/D = 1.5), 16 conveying elements (L/D = 1), 6 kneading elements (L/D = 0.25), 1 conveying element, 6 kneading elements, and 14 conveying elements, in that order.…”

Section: Continuous Twin-screw Granulationmentioning

confidence: 99%

Enabling energy‐efficient manufacturing of pharmaceutical solid oral dosage forms via integrated techno‐economic analysis and advanced process modeling

Sampat

Kotamarthy

Bhalode

et al. 2022

J Adv Manuf & Process

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The global pharmaceutical industry is a trillion-dollar market. However, the pharmaceutical sector often lags in manufacturing innovation and automation which limits its potential to maximize energy efficiency. The integration of technoeconomic analysis (TEA) with advanced process models as part of an overarching smart manufacturing platform, can help industries create business models, which can be adapted for manufacturing to reduce energy consumption and operating costs while ensuring product quality which can further enable a more sustainable process operation. In this study, a rational design of experiment on three unitoperations (wet granulation, drying, and milling) was performed on a batch (case 1) and continuous (case 2) pharmaceutical process to obtain experimental data. Process models for predicting product quality and energy efficiency of each of the three-unit operations were developed. The experimental data were used to validate the models and good agreement was observed. The energy consumption of each unit operation was calculated using statistical models relating the power consumption and the process parameters. The developed process models and energy models were further integrated into a TEA framework, which quantified the energy and monetary cost of manufacturing for both batch and continuous manufacturing cases. With this integrated framework, energy costs savings of ~33% was obtained in the continuous manufacturing process (case 2) over the batch process (case 1). K E Y W O R D Sadvanced process models, energy efficiency, Industry 4.0, smart manufacturing, technoeconomic analysis Chaitanya Sampata and Lalith Kotamarthy contributed equally to this study.

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“…pharmaceutical binders, diluents, disintegrants, film coating, release controlling agents and precipitation inhibitors) and can be modified for specific usage (Claeys et al, 2014;Fonteyne et al, 2014;Kadajji and Betageri, 2011;Pillay et al, 2013;Warren et al, 2013;Yang et al, 2010). Furthermore, polymers have been successfully used as stabilizing carriers in solid dispersion manufacturing, a drug formulation that has received a lot of attention in the past few years.…”

Section: Introductionmentioning

confidence: 99%

In-line monitoring of compaction properties on a rotary tablet press during tablet manufacturing of hot-melt extruded amorphous solid dispersions

Grymonpré

Verstraete

Bockstal

et al. 2017

International Journal of Pharmaceutics

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As the number of applications for polymers in pharmaceutical development is increasing, there is need for fundamental understanding on how such compounds behave during tableting. This research is focussed on the tableting behaviour of amorphous polymers, their solid dispersions and the impact of hot-melt extrusion on the compaction properties of these materials. Soluplus, Kollidon VA 64 and Eudragit EPO were selected as amorphous polymers since these are widely studied carriers for solid dispersions, while Celecoxib was chosen as BCS class II model drug. Neat polymers and physical mixtures (up to 35% drug load) were processed by hot-melt extrusion (HME), milled and sieved to obtain powders with comparable particle sizes as the neat polymer. A novel approach was used for in-line analysis of the compaction properties on a rotary tablet press (Modul P, GEA) using complementary sensors and software (CDAAS, GEA). By combining 'in-die' and 'out-of-die' techniques, it was possible to investigate in a comprehensive way the impact of HME on the tableting behaviour of amorphous polymers and their formulations. The formation of stable glassy solutions altered the formulations towards more fragmentary behaviour under compression which was beneficial for the tabletability.Principal component analysis (PCA) was applied to summarize the behaviour during compaction of the formulations, enabling the selection of Soluplus and Kollidon VA 64 as the most favourable polymers for compaction of glassy solutions.

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Distribution of binder in granules produced by means of twin screw granulation

Cited by 21 publications

References 9 publications

Examining drug hydrophobicity in continuous wet granulation within a twin screw extruder

Examining drug hydrophobicity in continuous wet granulation within a twin screw extruder

Enabling energy‐efficient manufacturing of pharmaceutical solid oral dosage forms via integrated techno‐economic analysis and advanced process modeling

In-line monitoring of compaction properties on a rotary tablet press during tablet manufacturing of hot-melt extruded amorphous solid dispersions

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