Melt Extrusion: Materials, Technology and Drug Product Design

✍ Scribed by Sejal Shah, Michael A. Repka (auth.), Michael A. Repka, Nigel Langley, James DiNunzio (eds.)

• Publisher: Springer-Verlag New York
• Year: 2013
• Tongue: English
• Leaves: 472
• Series: AAPS Advances in the Pharmaceutical Sciences Series 9
• Edition: 1
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Front Matter....Pages i-xii
Front Matter....Pages 1-1
Melt Extrusion in Drug Delivery: Three Decades of Progress....Pages 3-46
Twin Screw Extrusion for Pharmaceutical Processes....Pages 47-79
Front Matter....Pages 81-81
Properties and Applications of Polyvinyllactam Polymers....Pages 83-105
Properties and Applications of Hypromellose Acetate Succinate (HPMCAS) for Solubility Enhancement Using Melt Extrusion....Pages 107-121
Cellulose Ethers for Extrusion Applications....Pages 123-144
Properties and Applications of Polyethylene Oxide and Ethylcellulose for Tamper Resistance and Controlled Drug Delivery....Pages 145-158
Front Matter....Pages 159-159
Formulation Development of Amorphous Solid Dispersions Prepared by Melt Extrusion....Pages 161-203
Nonsink In Vitro Dissolution Testing of Amorphous Solid Dispersions....Pages 205-220
Front Matter....Pages 221-221
Manufacture of Pharmaceutically Relevant Materials by Mechanochemistry Using Twin Screw Extrusion....Pages 223-242
Melt Extruded Controlled Release Dosage Forms....Pages 243-260
Excipient or API Melt Processing via Injection Molding....Pages 261-279
Devices and Implants Prepared Using Hot Melt Extrusion....Pages 281-298
Solid Lipid Extrusion....Pages 299-328
Formulation, Bioavailability, and Manufacturing Process Enhancement: Novel Applications of Melt Extrusion in Enabling Product Development....Pages 329-362
Hot Melt Extrusion as a Continuous Pharmaceutical Manufacturing Process....Pages 363-396
Hot-Melt Extrusion Process Design Using Process Analytical Technology....Pages 397-431
Front Matter....Pages 433-433
Consistency of Pharmaceutical Products: An FDA Perspective on Hot-Melt Extrusion Process....Pages 435-445
Melt Extrusion: A Commercial Perception to Practicality....Pages 447-458
Future Trends....Pages 459-463
Back Matter....Pages 465-474

✦ Subjects

Biomedicine general; Pharmaceutical Sciences/Technology