Handbook of Pharmaceutical Wet Granulation

Ajit S. Narang works for the Bristol-Myers Squibb, Co. in New Brunswick, New Jersey, in the biopharmaceutical aspects of drug delivery. He has more than eight years of experience in the pharmaceutical industry in the development of oral dosage forms and drug delivery platforms. In addition to the Bristol-Myers Squibb, Co., he has worked for Ranbaxy Research Labs (currently a subsidiary of Daiichi Sankyo, Japan) in Gurgaon, India, and Morton Grove Pharmaceuticals (currently a subsidiary of Wockhardt USA LLC, Parsippany, New Jersey) in Vernon Hills, Illinois. He has more than 35 publications and three pending patent applications and has contributed to the development of several marketed drug products. Sherif Badawy, Ph.D., is a Research Fellow in the Drug product Science and Technology of the Bristol-Myers Squibb Company. He received his B.S. in Pharmacy and M.S. in Pharmaceutics from Cairo University, and his Ph.D. in Pharmaceutics from Duquesne University. He has more than 20 years of industrial experience in drug product development. His current responsibilities at Bristol-Myers Squibb include formulation and process development and scale-up of commercial oral solid and liquid dosage forms. His areas of research interest include high shear wet granulation, tablet compaction, stability of solid dosage forms and bioavailability enhancement of poorly water-soluble compounds. He authored more than 40 manuscripts and numerous abstracts and presentations in those areas.

• 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