Handbook of Pharmaceutical Wet Granulation : Theory and Practice in a Quality by Design Paradigm（2）

著者名：Narang, Ajit S. (EDT)/Badawy, Sherif I.F. (EDT)

Academic Press（2025/12/01発売）

• 言語：ENG
• ISBN：9780443298172
• eISBN：9780443298189

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.- Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation- Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms.- Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Table of Contents

Section 1: Process Design and Product Quality Attributes1. Physicochemical Principles Governing Agglomeration and Growth Kinetics2. Microstructure and Mechanical Properties of Granules Formed in High Shear Wet Granulation3. Mechanistic Basis for the Effects of Process Parameters on Quality Attributes in High Shear Wet Granulation4. Structures and Properties of Granules Prepared By High Shear Wet Granulation5. Wet Granulation and Chemical Stability of Drug Products6. Material Physical Modifications Induced by Wet Granulation (Current chapter 6)7. Current Practices in Wet Granulation-Based Generic Product DevelopmentSection 2: Excipients and Input Material Attributes8. Material Attributes and Their Impact on Wet Granulation Process Performance9. Binders in Wet Granulation10. Effect of Binder Attributes on Granule Growth and Densification11. Role of Drug Substance Material Properties in the Processibility and Performance of Wet Granulated Products12. Critical Material Attributes in Wet Granulation13. Critical material attributes during continuous twin-screw wet granulationSection 3: PAT, Scale-up, Control Strategy14. Inline Focused Beam Reflectance Measurement During Wet Granulation15. Principles and Applications of Drag Force Flow Sensor16. An Introduction to Powder Characterization17. A Quality By Design Approach to Scale-Up of High Shear Wet Granulation Process18. Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development19. Implementation of Pharmaceutical Quality by Design in Wet GranulationSection 4: Process Modeling and Emerging Trends20. Numerical Modeling for Wet Granulation Processes21. Application of the Discrete Element Method to Scale-Up of High-Shear Granulation22. Advances in Computational Modelling and Simulation of Wet Granulation Processes 23. Twin Screw Continuous Wet Granulation24. Melt granulation: Granulation mechanisms, Formulation and process design for batch and twin-screw systems25. The application of the state-of-art material library/material database approach to the process understanding and process modeling of wet granulation26. Emerging Paradigms in Pharmaceutical Wet Granulation