Conceptual framework for model-based analysis of residence time distribution in twin-screw granulation

Kumar, Ashish; Vercruysse, Jurgen; Vanhoorne, Valérie; Toiviainen, Maunu; Panouillot, Pierre-Emmanuel; Juuti, Mikko; Remon, Jean Paul; Gernaey, Krist V.; Beer, Thomas De; Nopens, Ingmar

doi:10.1016/j.ejps.2015.02.004

Cited by 49 publications

(50 citation statements)

References 18 publications

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“…The group also implemented an experimental design for both product and process variability assessment in terms of the granule size distribution. Kumar et al [50] investigated a novel method for better understanding and simulating the residence time distribution in a twin-screw extruder/granulator (TSG). In this HME-based CM approach, the study revealed that the kneading block serves as a plug-flow zone inside the granulator, which has a pivotal role in optimizing the bespoke platform.…”

Section: Applications Via Hmementioning

confidence: 99%

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Maniruzzaman

Nokhodchi

2017

Drug Discovery Today

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A c c e p t e d M a n u s c r i p t Highlights  HME can be exploited in a broad range of applications for advanced drug delivery  Unique advantages to be utilised in a solvent free manufacturing platform  A means to explore the potential of continuous manufacture of pharmaceuticals  Scale-up issue considerations, from an FDA compliance point of view  HME regulatory guidelines for the manufacture of novel drug delivery systems Ali NokhodchiAli Nokhodchi is a professor of pharmaceutics and drug delivery at the University of Sussex. He has supervised over 120 Mpharm, PharmD, and MSc students and 15 PhD postgraduate students at several institutions in various fields of pharmaceutical formulations and drug delivery. He is an editorial board member of over 20 peer-reviewed international journals. Ali has published over 185 research articles in various fields of pharmaceutics, including tableting, particle engineering, inhalation, nanoparticles, dissolution, skin delivery, and controlled-release formulations. In addition, he has published five book chapters on skin, controlled-release formulations, particle engineering, and inhalation products. Ali has also been the editor of a book on pulmonary delivery published by Wiley in 2015. He has been the recipient of several prizes in pharmaceutical sciences and has been listed by Essential Science Indicators in the top 1% scientists in the field of pharmacology and toxicology.Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.

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Section: Applications Via Hmementioning

confidence: 99%

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Maniruzzaman

Nokhodchi

2017

Drug Discovery Today

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“…Parameter identification based on RTD experimental data is straightforward, but the model fit is not always satisfactory [45], particularly with the plain CTRs-in-series model. The plug flow model compartment is often required and can improve the data reproduction to some extent [45,46].…”

Section: The Earlier Models: Static Mapsmentioning

confidence: 99%

“…The cascade of CSTRs models the completely filled part inducing a reflux and characterized by two parameters: the number of reactors n and the ratio between the forward and backward flows σ = Q Q B . • The works in [51] and [45] suggest another model inspired by [44] for a granulation process. A plug-flow reactor is placed in series with a cascade of CSTRs with dead zones (see Figure 8) where a fraction of the material is retained.…”

Section: The Earlier Models: Static Mapsmentioning

confidence: 99%

“…The selected number n of reactors varies significantly with the application, from eight in chocolate manufacturing [46] to 500-900 for a granulation process [45]. The reader is referred to the works [47,48] where the appropriate number of reactors is determined for different screw elements based on a thermo-mechanical partial differential equation (PDE) modeling.…”

Section: The Earlier Models: Static Mapsmentioning

confidence: 99%

“…The plug flow model compartment is often required and can improve the data reproduction to some extent [45,46].…”

Section: The Earlier Models: Static Mapsmentioning

confidence: 99%

See 2 more Smart Citations

A Review of Dynamic Models of Hot-Melt Extrusion

2016

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Hot-melt extrusion is commonly applied for forming products, ranging from metals to plastics, rubber and clay composites. It is also increasingly used for the production of pharmaceuticals, such as granules, pellets and tablets. In this context, mathematical modeling plays an important role to determine the best process operating conditions, but also to possibly develop software sensors or controllers. The early models were essentially black-box and relied on the measurement of the residence time distribution. Current models involve mass, energy and momentum balances and consists of (partial) differential equations. This paper presents a literature review of a range of existing models. A common case study is considered to illustrate the predictive capability of the main candidate models, programmed in a simulation environment (e.g., MATLAB). Finally, a comprehensive distributed parameter model capturing the main phenomena is proposed.

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Twin‐screw Granulation Process Development: Present Approaches, Understanding and Needs

Kumar

Gernaey

Beer

2017

Continuous Manufacturing of Pharmaceuticals

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Conceptual framework for model-based analysis of residence time distribution in twin-screw granulation

Cited by 49 publications

References 18 publications

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

A Review of Dynamic Models of Hot-Melt Extrusion

Twin‐screw Granulation Process Development: Present Approaches, Understanding and Needs

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