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热挤压成型Hot-Melt Extrusion: Pharmaceutical Applications
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Hot-Melt Extrusion: Pharmaceutical Applications Year: 2012 Edition: Language: English Pages: 385 Author Information Dr. Dionysios Douroumis, Senior Lecturer, School of Science, University of Greenwich, UK After completing his postgraduate studies Dr Douroumis worked as a postdoctoral fellow at the Friedrich – Schiller University of Jena in the Department of Pharmacy, and later as a Senior Scientist at Phoqus Pharmaceutical plc, tasked with the development of sustained/pulsatile release formulations, orally disintegrating tablets and taste masking of bitter drugs; some of these studies were in collaboration with Evonik GmbH in Darmstadt, Germany. He is currently Senior Lecture at the in the University of Greenwich School of Science where he coordinates the course for the MSc Pharmaceutical Science Programme (350 students per annum) and is also a tutor for undergraduate studies in Pharmaceutical Sciences. 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. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here. Content: Chapter 1 Single?Screw Extrusion: Principles (pages 1–21): Keith Luker Chapter 2 Twin?screw Extruders for Pharmaceutical Hot?melt Extrusion: Technology, Techniques and Practices (pages 23–42): Dirk Leister, Tom Geilen and Thobias Geissler Chapter 3 Hot?Melt Extrusion Developments in the Pharmaceutical Industry (pages 43–69): Ana Almeida, Bart Claeys, Jean Paul Remon and Chris Vervaet Chapter 4 Solubility Parameters for Prediction of Drug/Polymer Miscibility in Hot?Melt Extruded Formulations (pages 71–92): Andreas Gryczke Chapter 5 The Influence of Plasticizers in Hot?Melt Extrusion (pages 93–112): Geert Verreck Chapter 6 Applications of Poly(meth)acrylate Polymers in Melt Extrusion (pages 113–144): Kathrin Nollenberger and Jessica Albers Chapter 7 Hot?Melt Extrusion of Ethylcellulose, Hypromellose and Polyethylene Oxide (pages 145–175): Mark Hall and Michael Read Chapter 8 Bioadhesion Properties of Polymeric Films Produced by Hot?Melt Extrusion (pages 177–199): Joshua Boateng and Dennis Douroumis Chapter 9 Taste Masking Using Hot?Melt Extrusion (pages 201–221): Dennis Douroumis, Marion Bonnefille and Attila Aranyos Chapter 10 Clinical and Preclinical Studies, Bioavailability and Pharmacokinetics of Hot?Melt Extruded Products (pages 223–237): Sandra Guns and Guy Van den Mooter Chapter 11 Injection Molding and Hot?Melt Extrusion Processing for Pharmaceutical Materials (pages 239–259): Pernille Hoyrup Hemmingsen and Martin Rex Olsen Chapter 12 Laminar Dispersive and Distributive Mixing with Dissolution and Applications to Hot?Melt Extrusion (pages 261–284): Costas G. Gogos, Huiju Liu and Peng Wang Chapter 13 Technological Considerations Related to Scale?Up of Hot?Melt Extrusion Processes (pages 285–300): Adam Dreiblatt Chapter 14 Devices and Implant Systems by Hot?Melt Extrusion (pages 301–321): Andrew Loxley Chapter 15 Hot?Melt Extrusion: An FDA Perspective on Product and Process Understanding (pages 323–331): Abhay Gupta and Mansoor A. Khan Chapter 16 Improved Process Understanding and Control of a Hot?Melt Extrusion Process with near?Infrared Spectroscopy (pages 333–353): Chris Heil and Jeffrey Hirsch Description 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. |
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