How to Optimize Fluid Bed Processing Technology - 1st Edition - ISBN: 9780128047279, 9780128047286

How to Optimize Fluid Bed Processing Technology

1st Edition

Part of the Expertise in Pharmaceutical Process Technology Series

Authors: Dilip Parikh
eBook ISBN: 9780128047286
Paperback ISBN: 9780128047279
Imprint: Academic Press
Published Date: 6th April 2017
Page Count: 210
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Description

How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference.

This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation.

Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation.

Key Features

  • Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering
  • Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques
  • Offers troubleshooting tips and practical advice for scientists working with this technique

Readership

Pharmaceutical personnel, from R&D technicians to team leaders and department heads

Table of Contents

Chapter 1. Introduction

  • Abstract
  • 1.1 Introduction
  • 1.2 Advantages and Challenges of Fluidized Bed Granulation

Chapter 2. Fluidization Theory

  • Abstract
  • 2.1 How Does Fluidization Take Place?
  • 2.2 Understanding the Particles
  • 2.3 Types of Fluid Beds
  • 2.4 Controlling Gas Velocity
  • 2.5 Addressing Fluidization Challenges
  • 2.6 Summary
  • References

Chapter 3. Fluid Bed Processor Equipment and Its Functionality

  • Abstract
  • 3.1 Introduction
  • 3.2 Questions Before Specifying the Equipment
  • 3.3 Fluid Bed Processor Components
  • 3.4 Summary

Chapter 4. Process Development

  • Abstract
  • 4.1 Process Selection
  • 4.2 Quality by Design
  • 4.3 Processing in Fluid Bed
  • 4.4 Risk Assessment and Management
  • 4.5 Process Control
  • 4.6 Case Study
  • 4.7 Summary
  • Reference

Chapter 5. Granulation

  • Abstract
  • 5.1 Theory
  • 5.2 Binders
  • 5.3 Nozzles
  • 5.4 Process Parameters
  • 5.5 Challenges in Fluid Bed Granulation
  • 5.6 Granulation End Point
  • 5.7 Granulation Characterization
  • 5.8 Summary
  • References

Chapter 6. Drying

  • Abstract
  • 6.1 Theory
  • 6.2 Drying Granulated Product
  • 6.3 Summary
  • References

Chapter 7. Coating

  • Abstract
  • 7.1 Introduction
  • 7.2 Top-Spray Coating
  • 7.3 Wurster Coating
  • 7.4 Other Coating Modules
  • 7.5 Dry Powder Coating
  • 7.6 Problems in Coating in Fluid Bed
  • 7.8 Characterization of the Coating
  • 7.9 Selection of the Process for Coating
  • 7.10 Summary
  • References

Chapter 8. Pelletization

  • Abstract
  • 8.1 Introduction
  • 8.2 Pelletization With Wurster Coating Module
  • 8.3 Pelletization in Rotary Fluid Bed
  • 8.4 Case Studies
  • 8.5 Characterization of Pellets
  • 8.6 Summary
  • References

Chapter 9. Other Fluid Bed Processes and Applications

  • Abstract
  • 9.1 Introduction
  • 9.2 Fluidized Hot Melt Granulation (FHMG)
  • 9.3 Spray Congealing
  • 9.4 Pressure Swing Granulation (PSG)
  • 9.5 Wurster Module for Granulation
  • 9.6 Foam Granulation
  • 9.7 Steam Granulation
  • 9.8 Rotary Fluid Bed Agglomeration
  • 9.9 Spray-Drying Granulation
  • 9.10 Continuous Granulation
  • References

Chapter 10. Process Control and PAT

  • Abstract
  • 10.1 Background
  • 10.2 Process Control
  • 10.3 Temperature Measurement
  • 10.4 NIR
  • 10.5 Chord Length Determination (FBRM and SFV)
  • 10.6 The Lighthouse Probe
  • 10.7 Image analysis
  • 10.8 Other methods
  • 10.9 Summary
  • References

Chapter 11. Process Scale-Up

  • Abstract
  • 11.1 Introduction
  • 11.2 Various Scale-Up Considerations and Approaches
  • 11.3 Scale-Up of Fluid Bed Granulation and Drying
  • 11.4 Case Studies—Granulation Scale-Up
  • 11.5 Fluid Bed Coating Scale-Up
  • 11.6 Rotary Fluid Bed Coating
  • 11.7 Summary
  • References

Chapter 12. Integrated Systems

  • Abstract
  • 12.1 Material Handling
  • 12.2 Integrated Systems for Nonpotent Compounds
  • 12.3 Integrated Systems for Potent Compounds
  • 12.4 Summary
  • Reference

Chapter 13. Process Troubleshooting

  • Abstract
  • 13.1 Troubleshooting the Granulation Process
  • 13.2 Troubleshooting the Drying Process
  • 13.3 Troubleshooting the Coating Process
  • 13.4 Summary
  • References

Chapter 14. Fluid Bed Safety

  • Abstract
  • 14.1 Introduction
  • 14.2 Safety From Solvents
  • References

Details

No. of pages:
210
Language:
English
Copyright:
© Academic Press 2017
Published:
Imprint:
Academic Press
eBook ISBN:
9780128047286
Paperback ISBN:
9780128047279

About the Author

Dilip Parikh

Dilip M. Parikh is president of the pharmaceutical technology consulting group DPharma Group Inc. in the USA. As an industrial pharmacist, Parikh has more than 40 years of industrial experience in solid dosage technologies, cGMP complaint facility planning, process engineering and manufacturing and operational management at various major pharmaceutical companies in Canada and the U.S. Prior to starting DPharma Group, he held the position of vice president of operations and technology at Synthon Pharmaceuticals in North Carolina and vice president and general manager at Atlantic Pharmaceuticals Services in Maryland. He has authored several book chapters and articles on various pharmaceutical technologies, including quality by design, continuous manufacturing, process optimization and contract manufacturing. He has been an invited speaker at scientific conferences worldwide on solid-dosage technologies development and manufacturing.

Affiliations and Expertise

DPharma Group Inc, Maryland, USA