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

Buch, Englisch, 900 Seiten, Format (B × H): 216 mm x 279 mm

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

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

Inhaltsverzeichnis

1. Process Analytical Technologies to Study Granule Densification and Cohesion
2. Power consumption-based granulation end point: Does it Predict Scale-up?
3. A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation
4. Commonly used Mathematical Models in Wet Granulation
5. Elucidating Molecular Mechanisms of Wet Granulation using NIR Detection of Water and the Effect on Tablet Dissolution
6. Multivariate Analysis for Process Control of High Shear Wet Granulation
7. Impact of Granulation Techniques on Granule and Tablet Properties
8. Material Physical Modifications Induced by Wet Granulation (Current chapter 6)
9. Spectroscopic Methods for Real-time Monitoring of Pharmaceutical Wet Granulation
10. Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design
11. Artificial Intelligence Tools for Scaling Up of High Shear Wet Granulation Process
12. Model driven design for twin screw granulation using mechanistic-based population balance model
13. Machine learning models for prediction of granule properties in twin screw granulation
14. Design and scale up of fluid bed granulation
15. Process analytical methods for monitoring of 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.