Overview

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 extrusiontwin screw extrusion techniques and practices in the laboratory and on production scaleHME developments for the pharmaceutical industrysolubility parameters for prediction of drug/polymer miscibility in HME formulationsthe influence of plasticizers in HMEapplications of polymethacrylate polymers in HMEHME of ethylcellulose, hypromellose, and polyethylene oxidebioadhesion properties of polymeric films produced by HMEtaste masking using HMEclinical studies, bioavailability and pharmacokinetics of HME productsinjection moulding and HME processing for pharmaceutical materialslaminar dispersive & distributive mixing with dissolution and applications to HMEtechnological considerations related to scale-up of HME processesdevices and implant systems by HMEan FDA perspective on HME product and process understandingimproved process understanding and control of an HME process with near-infrared spectroscopy

Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science.

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9786613618702

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