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Predictive Modeling of Pharmaceutical Unit Operations
This book focuses on modeling techniques commonly used in drug development of solid dosage forms that are pertinent to pharmaceutical unit operations
Preetanshu Pandey (Edited by), Rahul Bharadwaj (Edited by)
9780081001547
Hardback, published 5 October 2016
464 pages
22.9 x 15.1 x 2.9 cm, 0.86 kg
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 Qualityby 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. 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
Subject Areas: Pharmacology [MMG], Pharmaceutical industries [KNDP]
