Hot-Melt Extrusion - (Advances in Pharmaceutical Technology) by Dennis Douroumis (Hardcover)

About the Book

"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"--

Book Synopsis

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.

This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

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.

About the Author

Dennis Douroumis University of Greenwich, UK