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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

1. Chapter 16 An introduction to powder characterization - p. 557 2. Chapter 17 A quality by design approach to scale-up of high-shear wet granulation process - p. 601 3. Chapter 18 Integrated application of quality-by-design principles to drug product and its control strategy development - p. 633 4. Chapter 19 Implementation of pharmaceutical quality by design in wet granulation - p. 669 5. Section IV Process modeling and emerging trends - p. 699 6. Chapter 20 Numerical modeling for wet granulation processes - p. 701 7. Chapter 21 Application of the discrete element method to scale-up of high-shear granulation - p. 725 8. Chapter 22 Advances in computational modeling and simulation of wet granulation processes - p. 747 9. Chapter 23 Twin-screw continuous wet granulation - p. 801 10. Chapter 24 Melt granulation: Granulation mechanisms, formulation and process design for batch and twin-screw systems - p. 837 11. Chapter 25 The application of the state-of-the-art material library/material database approach to the process understanding and process modeling of wet granulation - p. 867 12. Chapter 26 Emerging paradigms in pharmaceutical wet granulation - p. 911 13. Index - p. 927

Descripcion
Descripción

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

1. Chapter 16 An introduction to powder characterization - p. 557 2. Chapter 17 A quality by design approach to scale-up of high-shear wet granulation process - p. 601 3. Chapter 18 Integrated application of quality-by-design principles to drug product and its control strategy development - p. 633 4. Chapter 19 Implementation of pharmaceutical quality by design in wet granulation - p. 669 5. Section IV Process modeling and emerging trends - p. 699 6. Chapter 20 Numerical modeling for wet granulation processes - p. 701 7. Chapter 21 Application of the discrete element method to scale-up of high-shear granulation - p. 725 8. Chapter 22 Advances in computational modeling and simulation of wet granulation processes - p. 747 9. Chapter 23 Twin-screw continuous wet granulation - p. 801 10. Chapter 24 Melt granulation: Granulation mechanisms, formulation and process design for batch and twin-screw systems - p. 837 11. Chapter 25 The application of the state-of-the-art material library/material database approach to the process understanding and process modeling of wet granulation - p. 867 12. Chapter 26 Emerging paradigms in pharmaceutical wet granulation - p. 911 13. Index - p. 927

Indice
Autores
Muestra
Ficha Técnica