How to Scale-Up a Wet Granulation End Point Scientifically - 1st Edition - ISBN: 9780128035221, 9780128035603

How to Scale-Up a Wet Granulation End Point Scientifically

1st Edition

Authors: Michael Levin
eBook ISBN: 9780128035603
Paperback ISBN: 9780128035221
Imprint: Academic Press
Published Date: 21st October 2015
Page Count: 88
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Description

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.

Key Features

  • 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

Readership

Pharmaceutical personnel from R&D professionals to team leaders and department heads; those working in nutraceutical and generic manufacturing companies

Table of Contents

  • 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

Details

No. of pages:
88
Language:
English
Copyright:
© Academic Press 2016
Published:
Imprint:
Academic Press
eBook ISBN:
9780128035603
Paperback ISBN:
9780128035221

About the Author

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.

Affiliations and Expertise

Owner, Pharmaceutical Technology Consulting, Milev LLC, West Orange, NJ; General Manager, Measurement Control Corporation, East Hanover, NJ