Handbook of Pharmaceutical Wet Granulation - 1st Edition - ISBN: 9780128104606

Handbook of Pharmaceutical Wet Granulation

1st Edition

Theory and Practice in a Quality by Design Paradigm

Editors: Ajit Narang Sherif Badawy
Hardcover ISBN: 9780128104606
Imprint: Academic Press
Published Date: 1st November 2018
Page Count: 1008
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Description

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation.

Key Features

  • Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including high shear wet granulation (HSWG), low shear wet granulation (LSWG) and fluid bed granulation (FBG)
  • Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), product development and scale-up paradigms in batch processes, continuous manufacturing paradigms, and more
  • Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors that provide PAT tools and granulation equipment

Readership

Corporate industry researchers at pharmaceutical, biotechnology, excipient and drug delivery companies, academic researchers and graduate students in the pharmaceutical sciences, equipment manufacturers and chemical engineers

Table of Contents

Section I: Physicochemical Principles and Fundamentals of Wet Granulation
Section II: Critical Quality Attributes of Drug Products and Process Design Solutions
Section III:  Process-Stability Interactions and Optimization
Section IV:  Material Attributes Critical to Wet Granulation Process Performance
Section V: Process Modeling
Section VI: Scale-up
Section VII:  Process Development and Process Analytical Technology Applications
Section VIII:  Real-Time Release, Real-time Release Testing, and Drug Product Control Strategy Development

Details

No. of pages:
1008
Language:
English
Copyright:
© Academic Press 2019
Published:
Imprint:
Academic Press
Hardcover ISBN:
9780128104606

About the Editor

Ajit Narang

Affiliations and Expertise

Senior Scientist, Genentech, Inc., South San Francisco, CA, USA

Sherif Badawy

Affiliations and Expertise

Research Fellow, Drug Product Science and Technology, Bristol Myers Squibb, Co., New Brunswick, NJ, USA

Ratings and Reviews