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Chemical Engineering in the Pharmaceutical Industry, 2ed

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.

About the Author

Mary T. am Ende, PHD, 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 Ende, PHD, 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.

Contents

۱ Chemical Engineering in the Pharmaceutical Industry: An Introduction
۲ Current Challenges and Opportunities in the Pharmaceutical Industry
۳ Process Safety and Reaction Hazard Assessment
۴ Calorimetric Approaches to Characterizing Undesired Reactions
۵ Case Study of a Borane–THF Explosion
۶ Analytical Aspects for Determination of Mass Balances
۷ Quantitative Applications of NMR Spectroscopy
۸ Reaction Kinetics and Characterization
۹ Understanding Fundamental Processes in Catalytic Hydrogenation Reactions
۱۰ Characterization and First Principles Prediction of API Unit Operations
۱۱ Scale-Up of Mass Transfer-Limited Reactions: Fundamentals and a Case Study
۱۲ Scale-Up of Mixing Processes: A Primer
۱۳ Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing
۱۴ Process Development and Case Studies of Continuous Reactor Systems for Production of API and Pharmaceutical Intermediates
۱۵ Development and Application of Continuous Processes for the Intermediates and Active Pharmaceutical Ingredients
۱۶ Design and Selection of Continuous Reactors for Pharmaceutical Manufacturing
۱۷ Chemical Engineering Principles in Biologics: Unique Challenges and Applications
۱۸ Applications of Thermodynamics Toward Pharmaceutical Problem Solving
۱۹ A General Framework for Solid–Liquid Equilibria in Pharmaceutical Systems
۲۰ Drug Solubility, Reaction Thermodynamics, and Co-Crystal Screening
۲۱ Thermodynamic Modeling of Aqueous and Mixed Solvent Electrolyte Systems
۲۲ Thermodynamics and Relative Solubility Prediction of Polymorphic Systems
۲۳ Toward a Rational Solvent Selection for Conformational Polymorph Screening
۲۴ Crystallization Design and Scale-Up
۲۵ Introduction to Chiral Crystallization in Pharmaceutical Development and Manufacturing
۲۶ Measurement of Solubility and Estimation of Crystal Nucleation and Growth Kinetics
۲۷ Case Studies On Crystallization Scale-Up
۲۸ Population Balance-Enabled Model for Batch and Continuous Crystallization Processes
۲۹ Solid Form Development for Poorly Soluble Compounds
۳۰ Multiscale Assessment of API Physical Properties in the Context of Materials Science Tetrahedron Concept
۳۱ The Design and Economics of Large-Scale Chromatographic Separations
۳۲ Membrane Systems for Pharmaceutical Applications
۳۳ Design of Distillation and Extraction Operations
۳۴ Case Studies On the Use of Distillation in the Pharmaceutical Industry
۳۵ Design of Filtration and Drying Operations
۳۶ Filtration Case Studies
۳۷ Drying Case Studies
۳۸ Milling Operations in the Pharmaceutical Industry
۳۹ Experimental Design for Pharmaceutical Development
۴۰ Multivariate Analysis in API Development
۴۱ Probabilistic Models for Forecasting Process Robustness
۴۲ Use of Process Analytical Technology (PAT) in Small Molecule Drug Substance Reaction Development
۴۳ Process Modeling Applications Toward Enabling Development and Scale-Up: Chemical Reactions
۴۴ Process Scale-Up and Assessment
۴۵ Scale-Up Do’s and Don’ts
۴۶ Kilo Lab and Pilot Plant Manufacturing
۴۷ The Role of Simulation and Scheduling Tools in the Development and Manufacturing
۴۸ Scientific Opportunities through Quality by Design
۴۹ Applications of Quality Risk Assessment in Quality by Design (QbD) Drug Substance Process Development
۵۰ Development of Design Space for Reaction Steps: Approaches and Case Studies for Impurity Control

قیمت : 7000 تومان

لینک کوتاه : https://bookbaz.ir/?p=116467
نویسنده : Mary T. am Ende , David J. am Ende
ناشر : Wiley; 2 edition
سال انتشار : 2019
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 1784
(ISBN) شابک : 1119285496
قیمت کتاب درآمازون : $205.32
حجم فایل : 80 MB

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