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…mehr
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.
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
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
Es gelten unsere Allgemeinen Geschäftsbedingungen: www.buecher.de/agb
Impressum
www.buecher.de ist ein Internetauftritt der buecher.de internetstores GmbH
Geschäftsführung: Monica Sawhney | Roland Kölbl | Günter Hilger
Sitz der Gesellschaft: Batheyer Straße 115 - 117, 58099 Hagen
Postanschrift: Bürgermeister-Wegele-Str. 12, 86167 Augsburg
Amtsgericht Hagen HRB 13257
Steuernummer: 321/5800/1497
USt-IdNr: DE450055826
