Handbook of Pharmaceutical Granulation Technology

3. New Auflage 2009
ISBN: 978-1-4398-0789-7
Verlag: Taylor & Francis Inc

Buch, Englisch, 656 Seiten, Format (B × H): 184 mm x 261 mm, Gewicht: 1342 g

Reihe: Drugs and the Pharmaceutical Sciences

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.

Zielgruppe

Pharmaceutical scientists, manufacturing professionals, process engineers, analytical and pharmaceutical chemists, quality assurance and regulatory personnel, and upper-level undergraduate and graduate students in these disciplines.

Autoren/Hrsg.

Parikh, Dilip M.

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

PrefaceContributorsIntroduction, Dilip M. ParikhTheory of Granulation: An Engineering Perspective, Bryan J. EnnisPARTICLE FORMATIONDrug Substance and Excipient Characterization, Lai Wah Chan, Xiang Kou, and Paul W. S. HengBinders in Pharmaceutical Granulation, Thomas DürigSpray Drying and Pharmaceutical Applications, Metin Çelik and Susan C. WendellSupercritical Fluid Technology, Martin A. WahlPharmaceutical Applications of Nanoengineering, Deepak Thassu, Yashwant Pathak, and Michel DeleersGRANULATION PROCESSESRoller Compaction Technology, Ronald W. MillerWet Granulation in Low- and High-Shear Mixers, Rajeev Gokhale and Namrata R. TrivediBatch Fluid Bed Granulation, Dilip M. Parikh and David M. JonesSingle-Pot Processing, Harald Stahl and Griet Van VaerenberghExtrusion-Spheronization as a Granulation Technique, David F. ErkoboniContinuous Granulation, Chris Vervaet and Jean Paul RemonPRODUCT ORIENTED GRANULATIONSEffervescent Granulation, Guia BertuzziGranulation Approaches in Biotech Industry, Tuo Jin, Weien Yuan, and Hui LiGranulation of Plant Products and Nutraceuticals, Dilip M. ParikhGranulation Approaches for Modified Release Products, Neelima Phadnis and Sree NadkarniGranulation of Poorly Water-Soluble Drugs, Albert W. Brzeczko, Firas El Saleh, and Jiao YangGranulation Approaches for Orally Disintegrating Formulations, Gopi VenkateshMelt Granulation, Chris Vervaet and Jean Paul RemonCHARACTERIZATION AND SCALE-UPSizing of Granulation, Gurvinder Singh Rekhi and Richard SidwellGranulation Characterization, Cecil W. PropstBioavailability and Granule Properties, Sunil S. JambhekarGranulation Process Modeling, Ian T. Cameron and Fu Y. WangScale-Up Considerations in Granulation, Yinghe He, Lian X. Liu, James D. Litster, and Defne Kayrak-TalayAdvances in Process Controls and End-Point Determination, Kevin A. Macias and M. Teresa CarvajalOPTIMIZATION STRATEGIES, TOOLS AND REGULATORY CONSIDERATIONSExpert Systems and Their Use in Pharmaceutical Applications, Metin Çelik and Susan C. WendellRegulatory Issues in Granulation: The Pharmaceutical Quality for the 21st Century—A Risk-Based Approach, Prasad KannegantiQuality by Design and Process Analytical Technology in Granulation, Gopi Vudathala, Stanley Rodgers, and John E. SimmonsIndex