Predictive Modeling of Pharmaceutical Unit Operations

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.

Explains the commonly used modeling and simulation toolsDetails the modeling of various unit operations commonly utilized in solid dosage drug product manufacturingPractical examples of the application of modeling tools through case studiesDiscussion of modeling techniques used for a risk-based approach to regulatory filingsExplores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

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