Enhanced descriptions from Syndetics:

This book deals with various unique elements in the drugdevelopment process within chemical engineering science andpharmaceutical R&D. The book is intended to be used as aprofessional reference and potentially as a text book reference inpharmaceutical engineering and pharmaceutical sciences. Many of theexperimental methods related to pharmaceutical process developmentare learned on the job. This book is intended to provide many ofthose important concepts that R&D Engineers and manufacturingEngineers should know and be familiar if they are going to besuccessful in the Pharmaceutical Industry. These include basicanalytics for quantitation of reaction components? oftenskipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kineticmodeling and extends these concepts into Quality by Designstrategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamlineexperimental screening approaches is also new and presented here.Continuous flow processing, although mainstream for ChE, is uniquein this context given the range of scales and the complex economicsassociated with transforming existing batch-plant capacity.

The book will be split into four distinct yet related parts.These parts will address the fundamentals of analytical techniquesfor engineers, thermodynamic modeling, and finally provides anappendix with common engineering tools and examples of theirapplications.

Table of contents provided by Syndetics

• Preface
• Introduction
• 1 Chemical Engineering in the Pharmaceutical Industry: An Introduction
• 2 Current Challenges and Opportunities in the Pharmaceutical Industry
• 3 Chemical Engineering Principles in Biologics: Unique Challenges and Applications
• 4 Designing a Sustainable Pharmaceutical Industry: the Role of Chemical Engineers
• 5 Scientific Opportunities through Quality by Design
• Active Pharmaceutical Ingredient (API)
• 6 The Role of Chemical Engineering in Pharmaceutical API Process R&D
• 7 Reaction Kinetics and Characterization
• 8 Understanding Rate Processes in Catalytic Hydrogenation Reactions
• 9 Characterization and First Principles Prediction of API Reaction Systems
• 10 Modeling, Optimization, and Applications of Kinetic Mechanisms with OpenChem™
• 11 Process Safety and Reaction Hazard Assessment
• 12 Design of Distillation and Extraction Operations
• 13 Crystallization Design and Scale-Up
• 14 Scale-Up of Mixing Processes - A Primer
• 15 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing
• 16 Membrane Systems for Pharmaceutical Applications
• 17 Design of Filtration and Drying Operations
• 18 The Design and Economics of Large-Scale Chromatographic Separations
• 19 Milling Operations in the Pharmaceutical Industry
• 20 Process Scale-up and Assessment
• 21 Scale-Up Do's and Don'ts
• 22 Kilo Lab and Pilot Plant Manufacturing
• 23 Process Development and Case Studies of Continuous Reactor Systems for Production of API and pharmaceutical intermediates
• 24 Drug Solubility and Reaction Thermodynamics using CosmoRS™
• 25 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems
• 26 Towards a Rational Solvent Selection for Conformational Polymorph Screening
• 27 Molecular Thermodynamics for Pharmaceutical Process Modeling and Simulation
• 28 The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients
• Analytical Methods and Applied Statistics
• 29 Quality by Design for Analytical Methods
• 30 Analytical Chemistry for API Process Engineering
• 31 Quantitative Applications of NMR Spectroscopy
• 32 Experimental Design for Pharmaceutical Development
• 33 Multivariate Analysis for Pharmaceutical Development
• Drug Product
• 34 Process Modeling Techniques and Applications for Solid Oral Drug Products
• 35 Process Design and Development for Novel Pharmaceutical Dosage Forms
• 36 Design of Solid Dosage Formulations
• 37 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms
• 38 Design and Scale-Up of Dry Granulation Processes
• 39 Wet Granulation Processes
• 40 Spray Atomization Modeling for Tablet Film Coating Processes
• 41 The Freeze Drying Process: The use of mathematical modeling in process design, understanding and scale up
• 42 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions
• 43 Continuous Processing in Secondary Production
• 44 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization

Author notes provided by Syndetics