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
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.
Hot-melt extrusion (HME) is a relatively new process in the pharmaceutical industry, emerging as a processing technology for the preparation of various dosage forms and drug delivery systems.
Hot-melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME with a focus on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. It also includes recent and novel HME applications, scale-up considerations and regulatory issues.
This important new book presents a comprehensive study on the pharmaceutical applications of hot-melt extrusion, a field which until now has remained fragmented. By addressing basic operation principles and critical aspects of HME as well as cutting edge trends of extrusion based manufacturing technologies the reader is able to understand the effective processes needed to develop pharmaceutical products from lab scale to commercialization.
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.
From the Back Cover
ADVANCES IN PHARMACEUTICAL TECHNOLOGY
Hot-melt Extrusion Pharmaceutical Applications
Hot-melt extrusion (HME) is a relatively new process in the pharmaceutical industry, emerging as a processing technology for the preparation of various dosage forms and drug delivery systems.
Hot-melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME with a focus on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. It also includes recent and novel HME applications, scale-up considerations and regulatory issues.
This important new book presents a comprehensive study on the pharmaceutical applications of hot-melt extrusion, a field which until now has remained fragmented. By addressing basic operation principles and critical aspects of HME as well as cutting edge trends of extrusion based manufacturing technologies the reader is able to understand the effective processes needed to develop pharmaceutical products from lab scale to commercialization.
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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