Melt Extrusion : Materials, Technology and Drug Product Design By Repka, Michael A., Langley, Nigel, DiNunzio, James (Eds.)

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Melt Extrusion

Materials, Technology and Drug Product Design

SeriesAAPS Advances in the Pharmaceutical Sciences Series, Vol. 9

Repka, Michael A., Langley, Nigel, DiNunzio, James (Eds.)

2013, XII, 474 p. 266 illus., 125 illus. in color.

 

 

  • Discusses extensively the science of extrusion technology
  • Brings together all technical information necessary to develop and market pharmaceutical dosage forms
  • Provides the basic principles and fundamentals of extrusion technology

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 in Chemical 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.

Content Level » Research

Keywords » DiNunzio Equipment Extrusion Langley Melt Repka

 

Contents
Part I Introduction and Equipment
1 Melt Extrusion in Drug Delivery: Three Decades of Progress........ 3
Sejal Shah and Michael A. Repka
2 Twin Screw Extrusion for Pharmaceutical Processes . . . . . . . . . . . . . . . 47
Charlie Martin
Part II Excipients
3 Properties and Applications of Polyvinyllactam Polymers. . . . . . . . . . . 83
Karl Kolter
4 Properties and Applications of Hypromellose Acetate Succinate
(HPMCAS) for Solubility Enhancement Using Melt Extrusion . . . . . . 107
Sakaé Obara, Fumié K. Tanno and Ashish Sarode
5 Cellulose Ethers for Extrusion Applications . . . . . . . . . . . . . . . . . . . . . . . 123
Elanor Pinto and Thomas Dürig
6 Properties and Applications of Polyethylene Oxide
and Ethylcellulose for Tamper Resistance and Controlled Drug
Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Sampada B. Upadhye and Ali R. Rajabi-Siahboomi
Part III Formulation Design
7 Formulation Development of Amorphous Solid Dispersions
Prepared by Melt Extrusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
James C. DiNunzio and Dave A. Miller
8 Nonsink In Vitro Dissolution Testing
of Amorphous Solid Dispersions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Jeff T. Gautschi
Part IV Applications
9 Manufacture of Pharmaceutically Relevant Materials by
Mechanochemistry Using Twin Screw Extrusion . . . . . . . . . . . . . . . . . . . 223
Dominick Daurio, Karthik Nagapudi and Fernando Alvarez-Núñez
10 Melt Extruded Controlled Release Dosage Forms . . . . . . . . . . . . . . . . . . 243
Justin M. Keen and James W. McGinity
11 Excipient or API Melt Processing via Injection Molding . . . . . . . . . . . . 261
Costas G. Gogos
12 Devices and Implants Prepared Using Hot Melt Extrusion . . . . . . . . . . 281
Andrew Loxley
13 Solid Lipid Extrusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299
Peter Kleinebudde
14 Formulation, Bioavailability, and Manufacturing Process
Enhancement: Novel Applications of Melt Extrusion in
Enabling Product Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
Jay P. Lakshman
15 Hot Melt Extrusion as a Continuous Pharmaceutical
Manufacturing Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
Daniel Treffer, Patrick Wahl, Daniel Markl, Gerold Koscher,
Eva Roblegg and Johannes G. Khinast
16 Hot-Melt Extrusion Process Design Using Process
Analytical Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 397
Andreas Gryczke
Part V Regulatory and Commercialization Considerations
17 Consistency of Pharmaceutical Products: An FDA
Perspective on Hot-Melt Extrusion Process. . . . . . . . . . . . . . . . . . . . . . . . 435
Abhay Gupta and Mansoor A. Khan
18 Melt Extrusion: A Commercial Perception to Practicality . . . . . . . . . . . 447
Sejal P. Shah and Jörg Breitenbach
19 Future Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 459
Michael A. Repka
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465

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