How to Scale-Up a Wet Granulation End Point Scientifically
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About this ebook
How to Scale-Up a Wet Granulation End Point Scientifically provides a single-source devoted to all relevant information on the scale-up of a wet granulation end point.
Contents include a general description, problem identification, and theoretical background with supporting literature, case studies, potential solutions, and more. By outlining issues related to scale-up and end-point determination, and then using practical examples and advice to address these issues, How to Scale-Up a Wet Granulation End Point Scientifically is a valuable and essential resource for all those pharmaceutical scientists and technologists engaged in the granulation process.
- Thoroughly referenced and based on the latest research and literature
- Part of the Expertise in Pharmaceutical Process Technology Series edited by internationally respected expert, Michael Levin
- Illustrates the most common problems related to scale-up of a wet granulation end point and provides valuable insights on how to solve these problems in a practical way
Michael Levin
Michael Levin has over 30 years of experience in the field of pharmaceutical scale-up, instrumentation and process optimization. He has edited a “Pharmaceutical Process Scale-Up book, and has contributed chapters on “Tablet Press Instrumentation and “Wet Granulation: End-Point Determination and Scale-Up in the Encyclopedia of Pharmaceutical Technology. Michael holds a M.Sc. degree in History and Philosophy of Science from Hebrew University of Jerusalem and Ph.D. in BioMathematics (1980) from University of Washington in Seattle. His Post Doctorate studies were at University of Houston, Department of Mechanical Engineering. He participated in numerous wet and dry granulation and tableting projects in major pharmaceutical companies as a provider of process analytical instrumentation, conducted many seminars, performed numerous consulting services and wrote expert reports to clients in the pharmaceutical industry.
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Book preview
How to Scale-Up a Wet Granulation End Point Scientifically - Michael Levin
How to Scale-Up a Wet Granulation End Point Scientifically
Michael Levin, PhD
Milev, LLC, Pharmaceutical Technology Consulting, Measurement Control Corporation (MCC)
Table of Contents
Cover image
Title page
Copyright
Acknowledgments
About the Expertise in Pharmaceutical Process Technology Series
Format
Subject Matter
Target Audience
Introduction
Chapter 1. Scale-Up Basics
Abstract
Chapter 2. Dimensional Analysis
Abstract
2.1 Theory of Modeling and Principle of Similitude
2.2 Dimensionless Numbers
2.3 Π-Theorem
2.4 Relevance List
2.5 Dimensional Matrix
2.6 Examples
2.7 Comparison of Attainable Froude Numbers
Chapter 3. Wet Granulation
Abstract
3.1 Basics
3.2 What Can be Measured on a Mixer-Granulator?
3.3 End-Point Determination and Scale-Up: Semi-Empirical Methods
Chapter 4. Recommended Procedures: Case Studies
Abstract
4.1 Case Study I: Leuenberger et al. (1979, 1983)
4.2 Case Study II: Landin et al. (1996)
4.3 Case Study III: Faure et al. (1998)
4.4 Case Study IV: Landin et al. (1999)
4.5 Case Study V: Faure et al. (1999)
4.6 Case Study VI: Hutin et al. (2004)
4.7 Case Study VII: André et al. (2012)
Chapter 5. Practical Considerations for End-Point Scale-Up
Abstract
5.1 How to Define and Determine the End Point
5.2 How to Reproduce the End Point
5.3 How to Scale-Up the End Point
Chapter 6. List of Symbols and Dimensions
References
Index
Copyright
Academic Press is an imprint of Elsevier
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Copyright © 2016 Elsevier Inc. All rights reserved.
No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions
This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).
Notices
Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods or professional practices, may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information or methods described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.
ISBN: 978-0-12-803522-1
Library of Congress Cataloging-in-Publication Data
A catalog record for this book is available from the Library of Congress.
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library.
For Information on all Academic Press publications visit our website at http://store.elsevier.com/
Acknowledgments
Selected excerpts and figures from M. Levin, Granulation: End-Point Theory, Instrumentation, and Scale-Up, Education Anytime,
CD-ROM Short Course, AAPS 1999 are reprinted with permission.
Selected tables and figures from M. Levin, Wet Granulation: End-Point Determination and Scale-Up
in Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition, Taylor & Francis, Informa Ltd., 2013, are reprinted with permission.
About the Expertise in Pharmaceutical Process Technology Series
Numerous books and articles have been published on the subject of pharmaceutical process technology. While most of them cover the subject matter in depth and include detailed descriptions of the processes and associated theories and practices of operations, there seems to be a significant lack of practical guides and how to
publications.
The Expertise in Pharmaceutical Process Technology series is designed to fill this void. It comprises volumes on specific subjects with case studies and practical advice on how to overcome challenges that the practitioners in various fields of pharmaceutical technology are facing.
Format
• The series volumes will be published under the Elsevier Academic Press imprint in both paperback and electronic versions. Electronic versions will be full color, while print books will be published in black and white.
Subject Matter
• The series will be a collection of hands-on practical guides for practitioners with numerous case studies and step-by-step instructions for proper procedures and problem solving. Each topic will start with a brief overview of the subject matter and include an exposé, as well as practical solutions of the most common problems along with a lot of common sense (proven scientific rather than empirical practices).
• The series will try to avoid theoretical aspects of the subject matter and limit scientific/mathematical exposé (e.g., modeling, finite elements computations, academic studies, review of publications, theoretical aspects of process physics or chemistry) unless absolutely vital for understanding or justification of practical approach as advocated by the volume author. At best, it will combine both the practical (how to
) and scientific (why
) approach, based on practically proven solid theory – model – measurements. The main focus will be to ensure that a practitioner can use the recommended step-by-step approach to improve the results of his or her daily activities.
Target Audience
• The primary audience includes pharmaceutical personnel, from R&D and production technicians to team leaders and department heads. Some topics will also be of interest to people working in nutraceutical and generic manufacturing companies. The series will also be useful for those in academia and regulatory agencies. Each book in the series will target a specific audience.
The Expertise in Pharmaceutical Process Technology series presents concise, affordable, practical volumes that are valuable to patrons of pharmaceutical libraries as well as practitioners.
Welcome to the brave new world of practical guides to pharmaceutical technology!
Introduction
Michael Levin, PhD, Milev, LLC Pharmaceutical Technology Consulting
Judging by the number of recently published papers on the topic of end-point determination and scale-up of wet granulation process, the subject matter is still far from being settled in the