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Handbook of Pharmaceutical Wet Granulation

Theory and Practice in a Quality by Design Paradigm

Specificaties
Gebonden, blz. | Engels
Elsevier Science | e druk, 2025
ISBN13: 9780443298172
Rubricering
Elsevier Science e druk, 2025 9780443298172
€ 259,00
Levertijd ongeveer 8 werkdagen

Samenvatting

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.

Specificaties

ISBN13:9780443298172
Taal:Engels
Bindwijze:Gebonden

Inhoudsopgave

Section 1: Process Design and Product Quality Attributes<br>1. Physicochemical Principles Governing Agglomeration and Growth Kinetics<br>2. Microstructure and Mechanical Properties of Granules Formed in High Shear Wet Granulation<br>3. Mechanistic Basis for the Effects of Process Parameters on Quality Attributes in High Shear Wet Granulation<br>4. Structures and Properties of Granules Prepared By High Shear Wet Granulation<br>5. Wet Granulation and Chemical Stability of Drug Products<br>6. Material Physical Modifications Induced by Wet Granulation (Current chapter 6)<br>7. Current Practices in Wet Granulation-Based Generic Product Development<br>Section 2: Excipients and Input Material Attributes<br>8. Material Attributes and Their Impact on Wet Granulation Process Performance<br>9. Binders in Wet Granulation<br>10. Effect of Binder Attributes on Granule Growth and Densification<br>11. Role of Drug Substance Material Properties in the Processibility and Performance of Wet Granulated Products<br>12. Critical Material Attributes in Wet Granulation<br>13. Critical material attributes during continuous twin-screw wet granulation<br>Section 3: PAT, Scale-up, Control Strategy<br>14. Inline Focused Beam Reflectance Measurement During Wet Granulation<br>15. Principles and Applications of Drag Force Flow Sensor<br>16. An Introduction to Powder Characterization<br>17. A Quality By Design Approach to Scale-Up of High Shear Wet Granulation Process<br>18. Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development<br>19. Implementation of Pharmaceutical Quality by Design in Wet Granulation<br>Section 4: Process Modeling and Emerging Trends<br>20. Numerical Modeling for Wet Granulation Processes<br>21. Application of the Discrete Element Method to Scale-Up of High-Shear Granulation<br>22. Advances in Computational Modelling and Simulation of Wet Granulation Processes <br>23. Twin Screw Continuous Wet Granulation<br>24. Melt granulation: Granulation mechanisms, Formulation and process design for batch and twin-screw systems<br>25. The application of the state-of-art material library/material database approach to the process understanding and process modeling of wet granulation<br>26. Emerging Paradigms in Pharmaceutical Wet Granulation
€ 259,00
Levertijd ongeveer 8 werkdagen

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        Handbook of Pharmaceutical Wet Granulation