Pharmaceutical Extrusion Technology

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

Chapter 1 Twin-Screw Extruders for Pharmaceutical Products from a Technical and Historical PerspectiveCharles Martin Chapter 2 Extruder DesignRichard Steiner and Brian Haight Chapter 3 Control Strategy Considerations for Continuous Manufacturing Using Hot Melt ExtrusionCelia N. Cruz, Rapti Madurawe, Naresh Pavurala, and Sharmista Chatterjee Chapter 4 Twin-Screw Extrusion and Screw DesignWilliam Thiele Chapter 5 Die DesignJohn Perdikoulias and Tom Dobbie Chapter 6 Feeding Technology and Material Handling for Pharmaceutical ExtrusionSharon Nowak Chapter 7 Rheology, Torque, and Oscillatory RheometersScott T. Martin, Fengyuan Yang, and Thomas Durig Chapter 8 Foam ExtrusionGraciela Terife and Niloufar Faridi Chapter 9 Melt Pelletization and Size Reduction: Powder to Pellets and Powder to PowderChristopher C. Case, Albrecht Huber, and Kathrin Nickel Chapter 10 Extended-Release Dosage Forms Prepared Using Twin-Screw ExtrusionBo Lang, Xin Feng, and Feng Zhang Chapter 11 Shape Extrusion·Extruded Implantable Drug Delivery Devices: Materials, Applications, and ProcessingTony Listro and Bob Bessemer Chapter 12 Film, Sheet, and LaminatesBert Elliott and Brian Haight Chapter 13 Melt Extruded Amorphous Solid DispersionsPinak Khatri, Dipen Desai, Harpreet Sandhu, Atsawin Thongsukmak, Gaurang Patel, Jaydeep Vaghashiya, Wantanee Phuapradit, and Navnit Shah Chapter 14 Process Modeling and Simulation of Extrusion OperationsDavid Johnson, Rick Peng, and James DiNunzio Chapter 15 Devolatilization via Twin-Screw Extrusion: Theory, Tips, and Test ResultsCharles Martin and Brian Haight Chapter 16 Continuous Oral Solid Dose ManufactureMayur Lodaya and Michael Thompson Chapter 17 Installation, Commissioning, and QualificationAdam Dreiblatt Chapter 18 Extrusion Control SystemsStuart J. Kapp and Pete A. Palmer Index

Isaac Ghebre-Sellassie is President, Pharmaceutical Technology Solutions, Morris Plains, New Jersey, and Executive Director and Chief Scientific Officer, MEGA Pharmaceuticals, Asmara, Eritrea. Dr. Ghebre-Sellassie is the author or coauthor of more than 50 professional publications, including Multiparticulate Oral Drug Delivery and Pharmaceutical Pelletization Technology (both titles, Marcel Dekker Inc.), and the holder of 17 patents. A member of the American Association of Pharmaceutical Scientists and the International Society for Pharmaceutical Engineering, he received his M.S. (1978) and Ph.D. (1981) degrees from Purdue University, West Lafayette, Indiana. Charles Martin is President/General Manager of Leistritz Extrusion. He is responsible for the management of a company that provides manufacturing equipment and engineering services to the plastics, medical and pharmaceutical industries in the USA and around the world. Extensively published in trade publications, textbooks and journals, Charlie has delivered 100+ technical presentations at wide-ranging international events, and was the co-editor of the 1st edition of the textbook Pharmaceutical Extrusion Technology. He has been awarded 2 extrusion-related patents. Charlie earned his undergraduate degree from Gettysburg College, Gettysburg, Pennsylvania and MBA from Rutgers University, New Brunswick, New Jersey. Feng Zhang is an assistant professor at the University of Texas at Austin. Dr. Zhang is the author and coauthor of more than 40 publications and more than 10 patents. A member of American Association of Pharmaceutical Scientist, he received his Ph.D. degree (1999) in Pharmaceutical Science from the University of Texas at Austin, Austin, Texas. James DiNunzio is a Principal Scientist in the Formulation Sciences Group at Merck & Co., Inc. and currently leads the Hot-Melt Extrusion Subject Matter Expert team. He received his Ph.D. from the University of Texas at Austin in Pharmaceutics. He has published numerous research articles, book chapters, and is a co-inventor on multiple patents and patent applications. His current research interests include formulation design for melt extruded systems and the development of continuous manufacturing processes.