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- Wiley
More About This Title Chemical Engineering in the Pharmaceutical Industry, Second Edition: Drug Product Design, Development and Modeling
English
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition
The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling.
The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition:
- Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions
- Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up
- Offers analytical methods and applied statistics that highlight drug product quality attributes as design features
- Presents updated and new example calculations and associated solutions
- Includes contributions from leading experts in the field
Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
English
Mary T. am EndePh.D is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years’ experience in drug product formulation, process development and computational modeling.
David J. am EndePh.D. is President of Nalas Engineering Services, Inc. Previously, he was Research Fellow at Pfizer Inc. in the Chemical Research & Development department. He has over 25 years experience in chemical process development.
English
Preface
Contributors
Unit Conversions and Commonly used Formulas
Part I Introduction
Chapter 1 Chemical Engineering in the Pharmaceutical Industry: An Introduction
Part II Drug Product Design, Development & Modeling
Chapter 2 Design of Solid Dosage Formulations
Chapter 3 Powder Process Challenges and Solutions
Chapter 4 Design and Scale-up of Dry Granulation Processes
Chapter 5 Model based development of roller compaction processes
Chapter 6 Wet Granulation Processes
Chapter 7 Towards a generic model for twin-screw wet granulation
Chapter 8 Modeling a dosator capsule filling process for hard-shell capsules
Chapter 9 Powder Compaction – Process Design and Understanding
Chapter 10 Punch Sticking: Factors and Solutions
Chapter 11 Spray Atomization Modeling for Tablet Film Coating Processes
Chapter 12 Spray Drying and Amorphous Dispersions
Chapter 13 The Freeze Drying Process: The Use of Mathematical Modeling in Process Design, Understanding and Scale-up
Chapter 14 Sterilization Processes in the Pharmaceutical Industry
Chapter 15 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms
Chapter 16 Process Design and Development for Novel Pharmaceutical Dosage Forms
Chapter 17 Multiscale Modeling of a Pharmaceutical Fluid-bed Coating Process: Using CFD/DEM and Population-balance Models to Predict Coating Uniformity
Chapter 18 Process Design of Topical Semi-solids: Application of Fundamental Concepts in Pharmaceutical Engineering to PEG Ointment Development
Chapter 19 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions
Chapter 20 Drug Product Process Modeling
Part III Continuous Manufacturing
Chapter 21 Continuous Manufacturing in Secondary Production
Chapter 22 Continuous Direct Compression Using Portable Continuous Miniature Modular & Manufacturing (PCM&M)
Chapter 23 Process control levels for continuous pharmaceutical tablet manufacturing
Part IV Applied Statistics / Regulatory Environment
Chapter 24 Multivariate Analysis for Pharmaceutical and Medical Device Development
Chapter 25 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization
Chapter 26 Quality by Design: Pilot to Reality - The Honeymoon Phase to the Stormy Years
