This inclusive text describes hot melt extrusion for pharmaceutical applications, focusing on the materials used for the preparation of solid dispersions, fundamentals for preparing such systems and novel applications using extrusion technology.

Highlighting viewpoints from the academic, excipient, equipment, product development and regulatory communities, this comprehensive text compiles input from industry thought leaders to illustrate strategies and technologies for applying hot melt extrusion for drug product development while also providing insight into the path forward for the technology in years to come.

Dr. Michael A. Repka is Chair and Professor of the Department of Pharmaceutics at The University of Mississippi, as well as Director of the Pii Center for Pharmaceutical Technology. His research interests include the solubilization and delivery of poorly soluble bioactives via hot melt extrusion technology. Dr. Repka has established himself as an expert in this major pharmaceutical processing field through his numerous peer-reviewed publications, presentations and scientific talks.

Dr. Nigel Langley is currently Head of Marketing and Technical Sales at BASF Corporation where he is responsible for the promotion and technical support for BASF's pharmaceutical excipients and APIs to the Pharmaceutical Industry in North America. He has a strong interest in solubilization including hot melt extrusion. He received his Ph.D. in Liquid Crystals from Hull University, U.K., and an M.B.A. from Leeds University, U.K. Prior to joining BASF, he worked for Croda International in the U.K., Japan and the United States.

Dr. James DiNunzio is currently an Associate Principal Scientist at Merck & Co., Inc. where he serves as a member of the Hot Melt Extrusion Technology Development Team. He received his Ph.D. in Pharmacy from the University of Texas at Austin and holds M.S. and B.S. degrees inChemical Engineering from Columbia University and SUNY Buffalo, respectively. His research interests include formulation design of amorphous dispersions, development of controlled release products using melt extrusion, continuous manufacturing and engineering of directly shaped drug products.

Auteur

Dr. Michael A. Repka is Chair and Professor of the Department of Pharmaceutics at The University of Mississippi, as well as Director of the Pii Center for Pharmaceutical Technology. Dr. Repka joined the faculty at Ole Miss after receiving his Ph.D. from The University of Texas College of Pharmacy and founded a pharmaceutical research/development company that specializes in drug delivery. His research interests include oral transmucosal and transdermal/trans-nail delivery systems, as well as other novel dosage forms. Many of these systems are directed toward the solubilization and delivery of poorly soluble bioactives via Hot Melt Extrusion technology, which is a primary focus of his research. Dr. Repka's most important scientific accomplishments involve the advancement of melt extrusion technology. He has established himself as an expert in this major pharmaceutical processing field through his numerous peer-reviewed publications, presentations and scientific talks.

Dr. Nigel Langley is currently Head of Marketing and Technical Sales at BASF Corporation where he is responsible for the promotion and technical support for BASF's Pharmaceutical excipients and APIs to the Pharmaceutical Industry in North America. He has a strong interest in solubilization including Hot Melt Extrusion. He received his PhD in Liquid Crystals from Hull University, UK and an MBA from Leeds University, UK. Prior to joining BASF he worked for Croda International in UK, Japan and USA.

Dr. James DiNunzio is currently an Associate Principal Scientist in the Formulation & Basic Pharmaceutical Sciences Group at Merck & Co., Inc. where he serves as a member of the Hot Melt Extrusion Technology Development Team. He received his Ph.D. in Pharmacy from the University of Texas at Austin and holds M.S. and B.S. in Chemical Engineering from Columbia University and SUNY Buffalo, respectively. Prior to joining Merck, heserved as Senior Scientist at Hoffmann-La Roche where he was responsible for the development of enabled formulations using hot melt extrusion. He has also held scientific positions at PharmaForm, LLC and Forest Laboratories. With over seven years of industry experience, his research interests include formulation design of amorphous dispersions, development of controlled release products using melt extrusion, continuous manufacturing and engineering of directly shaped drug products.

Résumé
This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

Contenu

Melt Extrusion in Drug Delivery: Three Decades of Progress.- Twin Screw Extrusion for Pharmaceutical Processes.- Properties and Applications of Polyvinyllactam Polymers.- Properties and Applications of Hypromellose Acetate Succinate (HPMCAS) for Solubility Enhancement Using Melt Extrusion.- Cellulose Ethers for Extrusion Applications.- Properties and Applications of Polyethylene Oxide and Ethylcellulose for Tamper Resistance and Controlled Drug Delivery.- Formulation Development of Amorphous Solid Dispersions Prepared by Melt Extrusion.- Non-Sink In Vitro Dissolution Testing of Amorphous Solid Dispersions.- Manufacture of Pharmaceutically Relevant Materials by Mechanochemistry Using Twin Screw Extrusion.- Melt Extruded Controlled Release Dosage Forms.- Excipient/API Melt Processing via Injection Molding.- Devices and Implants Prepared Using Hot Melt Extrusion.- Solid Lipid Extrusion.- Formulation, Bioavailability and Manufacturing Process Enhancement: Novel Applications of Melt Extrusion in Enabling Product Development.- Hot Melt Extrusion as a Continuous Pharmaceutical Manufacturing Process.- Hot-Melt Extrusion Process Design Using Process Analytical Technology.- Consistency of Pharmaceutical Products: An FDA Perspective on Hot-melt Extrusion Process.- Melt Extrusion: A Commercial Perception to Practicality.- Future Trends.