Predictive Modeling of Pharmaceutical Unit Operations

Table of Contents

1. Modeling of drug product manufacturing processes in the pharmaceutical industry

2. Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations

3. Powder flow and blending

4. Dry granulation process modeling

5. Mechanistic modeling of high-shear and twin screw mixer granulation processes

6. Fluid bed granulation and drying

7. Modeling of milling processes via DEM, PBM, and microhydrodynamics

8. Modeling of powder compaction with the drucker-prager cap model

9. Modeling approaches to multilayer tableting

10. Computational modeling of pharmaceutical die filling processes

11. Modeling tablet film-coating processes

12. Modeling in pharmaceutical packaging

13. Continuous secondary process selection and the modeling of batch and continuous wet granulation

14. Process modeling in the biopharmaceutical industry

Authors

Preetanshu Pandey Principal Scientist in the Dept. of Drug Product Science and Technology at Bristol-Myers Squibb, New Brunswick, NJ, USA .. Preetanshu Pandey obtained his Bachelor's chemical engineering degree from Indian Institute of Technology, Kanpur, India. He holds a M.S. and Ph.D. degree in chemical engineering from West Virginia University. He is currently working as a Principal Scientist at the Drug Product Science and Technology department at Bristol-Myers Squibb. At BMS, he is primarily involved with developing oral solid dosage drug products. Prior to joining BMS, he worked at Schering-Plough/Merck for over 3 years on drug product development of inhalation products. He is actively involved with AAPS and AICHE organizations and has chaired symposiums and open forums in previous annual meetings. He serves as a reviewer for multiple journals and has authored over 40 peer-reviewed publications, 3 patent applications, and 3 invited book chapters. Rahul Bharadwaj Vice-President of Engineering and Business Development at Rocky DEM, Inc.. Dr. Rahul Bharadwaj is the Vice-President of Engineering and Business Development at Rocky DEM, Inc. Dr. Bharadwaj has over a decade of experience in the development, validation and application of computational tools such as Discrete Element Modeling (DEM), Computational Fluid Dynamics and Finite Element Analyses for industries such as pharmaceutical, chemical, agriculture, mining, oil & gas, etc. He received his M.S. in Mechanical Engineering from the University of Kentucky (2003) and a Ph.D. in Mechanical Engineering from Purdue University (2006). He has since then held positions as senior scientist in Pfizer R&D and also as a consulting engineer at Jenike and Johanson Inc. He is also an active member of American Institute of Chemical Engineers (AIChE), American Association of Pharmaceutical Scientists (AAPS), and is the founder and past-chair of its Process Modeling and Simulation Focus Group