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Advances in Twin-Screw Granulation Processing

Nandi, Uttom, Trivedi, Vivek, Ross, Steven A., Douroumis, Dennis (2021) Advances in Twin-Screw Granulation Processing. Pharmaceutics, 13 (5). Article Number 624. E-ISSN 1999-4923. (doi:10.3390/pharmaceutics13050624) (KAR id:88771)

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Official URL:
https://doi.org/10.3390/pharmaceutics13050624

Abstract

Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest from the pharmaceutical industry for its potential for the development of oral dosage forms. The technology has evolved rapidly due to the flexibility of the equipment design, the selection of the process variables and the wide range of processed materials. Most importantly, TSG offers the benefits of both batch and continuous manufacturing for pharmaceutical products, accompanied by excellent process control, high product quality which can be achieved through the implementation of Quality by Design (QbD) approaches and the integration of Process Analytical Tools (PAT). Here, we present basic concepts of the various twin-screw granulation techniques and present in detail their advantages and disadvantages. In addition, we discuss the detail of the instrumentation used for TSG and how the critical processing paraments (CPP) affect the critical quality attributes (CQA) of the produced granules. Finally, we present recent advances in TSG continuous manufacturing including the paradigms of modelling of continuous granulation process, QbD approaches coupled with PAT monitoring for granule optimization and process understanding.

Item Type: Article
DOI/Identification number: 10.3390/pharmaceutics13050624
Uncontrolled keywords: twin-screw granulation; granulation mechanisms; PAT tools; QbD; continuous processing
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: Divisions > Division of Natural Sciences > Medway School of Pharmacy
Signature Themes: Future Human
Depositing User: Vivek Trivedi
Date Deposited: 21 Jun 2021 08:41 UTC
Last Modified: 22 Jun 2021 08:24 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/88771 (The current URI for this page, for reference purposes)
Trivedi, Vivek: https://orcid.org/0000-0001-9304-9214
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