3rd Edition

Handbook of Pharmaceutical Granulation Technology




ISBN 9781439807897
Published November 24, 2009 by CRC Press
656 Pages - 300 B/W Illustrations

USD $230.00

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Book Description

The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the reader in selecting the ideal technology for his/her company’s particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner.

Here are just a few of the new topics discussed in this revised and expanded handbook:

  • spray drying
  • nanotechnology
  • biotechnologically derived drugs
  • nutraceuticals
  • controlled release drugs
  • particle engineering
  • supercritical fluids
  • concepts of design space
  • process optimization
  • regulation harmonization by global health authorities
  • process controlexpert systems
  • Process Analytical Technology (PAT)
  • regulatory issues in granulation

In addition, all chapters in the Handbook of Pharmaceutical Granulation Technology explore the fundamentals of powder characterization, granulation, and state-of-the-art technologies, modeling, application of expert systems, and manufacturing optimization.

Table of Contents

Preface
Contributors
Introduction, Dilip M. Parikh
Theory of Granulation: An Engineering Perspective,
Bryan J. Ennis

PARTICLE FORMATION
Drug Substance and Excipient Characterization,
Lai Wah Chan, Xiang Kou, and Paul W. S. Heng
Binders in Pharmaceutical Granulation,
Thomas Dürig
Spray Drying and Pharmaceutical Applications,
Metin Çelik and Susan C. Wendell
Supercritical Fluid Technology,
Martin A. Wahl
Pharmaceutical Applications of Nanoengineering,
Deepak Thassu, Yashwant Pathak, and Michel Deleers

GRANULATION PROCESSES
Roller Compaction Technology,
Ronald W. Miller
Wet Granulation in Low- and High-Shear Mixers, Rajeev Gokhale and Namrata R. Trivedi
Batch Fluid Bed Granulation,
Dilip M. Parikh and David M. Jones
Single-Pot Processing,
Harald Stahl and Griet Van Vaerenbergh
Extrusion-Spheronization as a Granulation Technique,
David F. Erkoboni
Continuous Granulation,
Chris Vervaet and Jean Paul Remon

PRODUCT ORIENTED GRANULATIONS
Effervescent Granulation,
Guia Bertuzzi
Granulation Approaches in Biotech Industry,
Tuo Jin, Weien Yuan, and Hui Li
Granulation of Plant Products and Nutraceuticals,
Dilip M. Parikh
Granulation Approaches for Modified Release Products,
Neelima Phadnis and Sree Nadkarni
Granulation of Poorly Water-Soluble Drugs,
Albert W. Brzeczko, Firas El Saleh, and Jiao Yang
Granulation Approaches for Orally Disintegrating Formulations,
Gopi Venkatesh
Melt Granulation, Chris Vervaet and Jean Paul Remon

CHARACTERIZATION AND SCALE-UP
Sizing of Granulation,
Gurvinder Singh Rekhi and Richard Sidwell
Granulation Characterization,
Cecil W. Propst
Bioavailability and Granule Properties,
Sunil S. Jambhekar
Granulation Process Modeling,
Ian T. Cameron and Fu Y. Wang
Scale-Up Considerations in Granulation,
Yinghe He, Lian X. Liu, James D. Litster, and Defne Kayrak-Talay
Advances in Process Controls and End-Point Determination,
Kevin A. Macias and M. Teresa Carvajal

OPTIMIZATION STRATEGIES, TOOLS AND REGULATORY CONSIDERATIONS
Expert Systems and Their Use in Pharmaceutical Applications,
Metin Çelik and Susan C. Wendell
Regulatory Issues in Granulation: The Pharmaceutical Quality for the 21st Century—A Risk-Based Approach,
Prasad Kanneganti
Quality by Design and Process Analytical Technology in Granulation, Gopi Vudathala, Stanley Rodgers, and John E. Simmons
Index

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Reviews

"…comprehensive….

"… very useful for pharmaceutical professionals."

-IASI Polytechnic Magazine (for previous edition)