Handbook of Pharmaceutical Wet Granulation
Theory and Practice in a Quality by Design Paradigm
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Product details:
- Edition number 2
- Publisher Elsevier Science
- Date of Publication 1 December 2025
- ISBN 9780443298172
- Binding Hardback
- No. of pages900 pages
- Size 235x191 mm
- Weight 450 g
- Language English 700
Categories
Long description:
Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm, Second Edition 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. This completely revised and updated edition features five new chapters covering new AI tools applied to scaling up granulation processes, model drive design, machine learning models for granule property prediction, design and scale up of fluid bed granulation, and process analytical methods. This book is the prefect reference for pharmaceutical manufacturing professionals. Academic researchers will benefit from the practical advice provided by the editors and chapter authors.
MoreTable of Contents:
Section 1: Process Design and Product Quality Attributes
1. Physicochemical Principles Governing Agglomeration and Growth Kinetics
2. Microstructure and Mechanical Properties of Granules Formed in High Shear Wet Granulation
3. Mechanistic Basis for the Effects of Process Parameters on Quality Attributes in High Shear Wet Granulation
4. Structures and Properties of Granules Prepared By High Shear Wet Granulation
5. Wet Granulation and Chemical Stability of Drug Products
6. Material Physical Modifications Induced by Wet Granulation (Current chapter 6)
7. Current Practices in Wet Granulation-Based Generic Product Development
Section 2: Excipients and Input Material Attributes
8. Material Attributes and Their Impact on Wet Granulation Process Performance
9. Binders in Wet Granulation
10. Effect of Binder Attributes on Granule Growth and Densification
11. Role of Drug Substance Material Properties in the Processibility and Performance of Wet Granulated Products
12. Critical Material Attributes in Wet Granulation
13. Critical material attributes during continuous twin-screw wet granulation
Section 3: PAT, Scale-up, Control Strategy
14. Inline Focused Beam Reflectance Measurement During Wet Granulation
15. Principles and Applications of Drag Force Flow Sensor
16. An Introduction to Powder Characterization
17. A Quality By Design Approach to Scale-Up of High Shear Wet Granulation Process
18. Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development
19. Implementation of Pharmaceutical Quality by Design in Wet Granulation
Section 4: Process Modeling and Emerging Trends
20. Numerical Modeling for Wet Granulation Processes
21. Application of the Discrete Element Method to Scale-Up of High-Shear Granulation
22. Advances in Computational Modelling and Simulation of Wet Granulation Processes
23. Twin Screw Continuous Wet Granulation
24. Melt granulation: Granulation mechanisms, Formulation and process design for batch and twin-screw systems
25. The application of the state-of-art material library/material database approach to the process understanding and process modeling of wet granulation
26. Emerging Paradigms in Pharmaceutical Wet Granulation
