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Hot-melt extrusion (HME) – melting a substance and forcing it through an orifice under controlled conditions to form a new material – is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include:
principles and die design of single screw extrusion
twin screw extrusion techniques and practices in the laboratory and on production scale
HME developments for the pharmaceutical industry
solubility parameters for prediction of drug/polymer miscibility in HME formulations
the influence of plasticizers in HME
applications of polymethacrylate polymers in HME
HME of ethylcellulose, hypromellose, and polyethylene oxide
bioadhesion properties of polymeric films produced by HME
taste masking using HME
clinical studies, bioavailability and pharmacokinetics of HME products
injection moulding and HME processing for pharmaceutical materials
laminar dispersive & distributive mixing with dissolution and applications to HME
technological considerations related to scale-up of HME processes
devices and implant systems by HME
an FDA perspective on HME product and process understanding
improved process understanding and control of an HME process with near-infrared spectroscopy
Author Biography
Dr. Dionysios Douroumis, Senior Lecturer, School of Science,University of Greenwich, UK After completing his postgraduate studies Dr Douroumis worked as apostdoctoral fellow at the Friedrich Schiller University ofJena in the Department of Pharmacy, and later as a Senior Scientistat Phoqus Pharmaceutical plc, tasked with the development ofsustained/pulsatile release formulations, orally disintegratingtablets and taste masking of bitter drugs; some of these studieswere in collaboration with Evonik GmbH in Darmstadt, Germany. He iscurrently Senior Lecture at the in the University of GreenwichSchool of Science where he coordinates the course for the MScPharmaceutical Science Programme (350 students per annum) and isalso a tutor for undergraduate studies in Pharmaceutical Sciences.
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