Douroumis D. (Ed.) Hot-Melt Extrusion: Pharmaceutical Applications

John Wiley & Sons Ltd, 2012. – 385 p. – ISBN: 0470711183Hot-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 spectroscopySingle-screw Extrusion: Principles
Twin-screw Extruders for Pharmaceutical Hot-melt Extrusion: Technology, Techniques and Practices
Hot-melt Extrusion Developments in the Pharmaceutical Industry
Solubility Parameters for Prediction of Drug/Polymer Miscibility in Hot-melt Extruded Formulations
The Influence of Plasticizers in Hot-melt Extrusion
Applications of Poly(meth)acrylate Polymers in Melt Extrusion
Hot-melt Extrusion of Ethylcellulose, Hypromellose and Polyethylene Oxide
Bioadhesion Properties of Polymeric Films Produced by Hot-melt Extrusion
Taste Masking Using Hot-melt Extrusion
Clinical and Preclinical Studies, Bioavailability and Pharmacokinetics of Hot-melt Extruded Products
Injection Molding and Hot-melt Extrusion Processing for Pharmaceutical Materials
Laminar Dispersive and Distributive Mixing with Dissolution and Applications to Hot-melt Extrusion
Technological Considerations Related to Scale-up of Hot-melt Extrusion Processes
Devices and Implant Systems by Hot-melt Extrusion
Hot-melt Extrusion: An FDA Perspective on Product and Process Understanding
Improved Process Understanding and Control of a Hot-melt Extrusion Process with Near-Infrared Spectroscopy