The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality
by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included.
1. Cover image - p. Cover 2. Title page - p. iii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. List of contributors - p. ix 6. Predictive modeling of pharmaceutical unit operations - p. xiii 7. Preface - p. xxv 8. 1. Modeling of drug product manufacturing processes in the pharmaceutical industry - p. 1 9. 2. Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations - p. 15 10. 3. Powder flow and blending - p. 39 11. 4. Dry granulation process modeling - p. 71 12. 5. Mechanistic modeling of high-shear and twin screw mixer granulation processes - p. 99 13. 6. Fluid bed granulation and drying - p. 137 14. 7. Modeling of milling processes via DEM, PBM, and microhydrodynamics - p. 159 15. 8. Modeling of powder compaction with the drucker–prager cap model - p. 205 16. 9. Modeling approaches to multilayer tableting - p. 229 17. 10. Computational modeling of pharmaceutical die filling processes - p. 253 18. 11. Modeling tablet film-coating processes - p. 273 19. 12. Modeling in pharmaceutical packaging - p. 317 20. 13. Continuous secondary process selection and the modeling of batch and continuous wet granulation - p. 343 21. 14. Process modeling in the biopharmaceutical industry - p. 383 22. Index - p. 427
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality
by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included.
1. Cover image - p. Cover 2. Title page - p. iii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. List of contributors - p. ix 6. Predictive modeling of pharmaceutical unit operations - p. xiii 7. Preface - p. xxv 8. 1. Modeling of drug product manufacturing processes in the pharmaceutical industry - p. 1 9. 2. Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations - p. 15 10. 3. Powder flow and blending - p. 39 11. 4. Dry granulation process modeling - p. 71 12. 5. Mechanistic modeling of high-shear and twin screw mixer granulation processes - p. 99 13. 6. Fluid bed granulation and drying - p. 137 14. 7. Modeling of milling processes via DEM, PBM, and microhydrodynamics - p. 159 15. 8. Modeling of powder compaction with the drucker–prager cap model - p. 205 16. 9. Modeling approaches to multilayer tableting - p. 229 17. 10. Computational modeling of pharmaceutical die filling processes - p. 253 18. 11. Modeling tablet film-coating processes - p. 273 19. 12. Modeling in pharmaceutical packaging - p. 317 20. 13. Continuous secondary process selection and the modeling of batch and continuous wet granulation - p. 343 21. 14. Process modeling in the biopharmaceutical industry - p. 383 22. Index - p. 427
