Handbook of Pharmaceutical Wet Granulation

Theory and Practice in a Quality by Design Paradigm
2. Auflage 2025
ISBN: 978-0-443-29817-2
Verlag: Elsevier Science Publishing Co Inc

Buch, Englisch, 900 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 450 g

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.

Autoren/Hrsg.

Narang, Ajit S.

Badawy, Sherif I. F.

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie
• Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie

Inhaltsverzeichnis

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

Über Autor(innen)

Narang, Ajit S.
Ajit S. Narang works for the Bristol-Myers Squibb, Co. in New Brunswick, New Jersey, in the biopharmaceutical aspects of drug delivery. He has more than eight years of experience in the pharmaceutical industry in the development of oral dosage forms and drug delivery platforms. In addition to the Bristol-Myers Squibb, Co., he has worked for Ranbaxy Research Labs (currently a subsidiary of Daiichi Sankyo, Japan) in Gurgaon, India, and Morton Grove Pharmaceuticals (currently a subsidiary of Wockhardt USA LLC, Parsippany, New Jersey) in Vernon Hills, Illinois. He has more than 35 publications and three pending patent applications and has contributed to the development of several marketed drug products.

Badawy, Sherif I. F.
Sherif Badawy, Ph.D., is a Research Fellow in the Drug product Science and Technology of the Bristol-Myers Squibb Company. He received his B.S. in Pharmacy and M.S. in Pharmaceutics from Cairo University, and his Ph.D. in Pharmaceutics from Duquesne University. He has more than 20 years of industrial experience in drug product development. His current responsibilities at Bristol-Myers Squibb include formulation and process development and scale-up of commercial oral solid and liquid dosage forms. His areas of research interest include high shear wet granulation, tablet compaction, stability of solid dosage forms and bioavailability enhancement of poorly water-soluble compounds. He authored more than 40 manuscripts and numerous abstracts and presentations in those areas.