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Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach

Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach

Islam, Muhammad T., Maniruzzaman, Mohammed, Halsey, Sheelagh A., Chowdhry, Babur Z. and Douroumis, Dennis (2014) Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach. Drug Delivery and Translational Research, 4 (4). pp. 377-387. ISSN 2190-393X (Print), 2190-3948 (Online) (doi:10.1007/s13346-014-0197-8)

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Abstract

In this study, a quality-by-design (QbD) approach was used to optimize the development of paracetamol (PMOL) sustained-release formulations manufactured by hot-melt extrusion (HME). For the purpose of the study, in-line near-infrared (NIR) spectroscopy as a process analytical technology (PAT) was explored while a design of experiment (DoE) was implemented to assess the effect of the process critical parameters and to identify the critical quality attributes (CQA) of the extrusion processing. Blends of paracetamol, ethyl cellulose (EC) and Compritol® 888 ATO (C888) were processed using a twin screw extruder to investigate the effect of screw speed, feed rate and drug loading on the dissolution rates and particle size distribution. The principal component analysis (PCA) of the NIR collected signal revealed the optimum extrusion processing parameters. Furthermore, the integration of the DoE experiments demonstrated that drug loading has a significant effect on the only quality attribute, which was the PMOL dissolution rate. This QbD approach was employed as a paradigm for the development of pharmaceutical formulations via HME processing.

Item Type: Article
Additional Information: Drug Delivery and Translational Research is an Official Journal of the Controlled Release Society.
Uncontrolled Keywords: hot-melt extrusion, in-line NIR, process analytical technology, quality by design, critical quality attributes
Subjects: R Medicine > RS Pharmacy and materia medica
Faculty / Department / Research Group: Faculty of Engineering & Science
Faculty of Engineering & Science > Department of Pharmaceutical, Chemical & Environmental Sciences
Last Modified: 17 Oct 2016 13:58
Selected for GREAT 2016: None
Selected for GREAT 2017: None
Selected for GREAT 2018: None
URI: http://gala.gre.ac.uk/id/eprint/12182

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