Free Download Chemical Engineering in the Pharmaceutical Industry by David J. Am Ende 2nd Ed

Active Pharmaceutical Ingredients

2nd Edition

Authors of: Chemical Engineering in the Pharmaceutical Industry by David J. Am Ende 2nd Ed

DAVID J. AM ENDE

MARY T. AM ENDE

Table of Contents in Chemical Engineering in the Pharmaceutical Industry by David J. Am Ende 2nd Ed

LIST OF CONTRIBUTORS

PREFACE

UNIT CONVERSIONS

PART I INTRODUCTION

1 Chemical Engineering in the Pharmaceutical Industry: An Introduction

2 Current Challenges and Opportunities in the Pharmaceutical Industry

PART II MASS AND ENERGY BALANCES

3 Process Safety and Reaction Hazard Assessment

4 Calorimetric Approaches to Characterizing Undesired Reactions

5 Case Study of a Borane–THF Explosion

6 Analytical Aspects for Determination of Mass Balances

7 Quantitative Applications of NMR Spectroscopy

PART III REACTION KINETICS AND MIXING PROCESSES

8 Reaction Kinetics and Characterization

9 Understanding Fundamental Processes in Catalytic Hydrogenation Reactions

10 Characterization and First Principles Prediction of API Unit Operations

11 Scale-Up of Mass Transfer-Limited Reactions: Fundamentals and a Case Study

12 Scale-Up of Mixing Processes: A Primer

13 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing

PART IV CONTINUOUS PROCESSING

14 Process Development and Case Studies of Continuous Reactor Systems for Production of API

and Pharmaceutical Intermediates

15 Development and Application of Continuous Processes for the Intermediates and Active Pharmaceutical Ingredients

16 Design and Selection of Continuous Reactors for Pharmaceutical Manufacturing

PART V BIOLOGICS

17 Chemical Engineering Principles in Biologics: Unique Challenges and Applications

PART VI THERMODYNAMICS

18 Applications of Thermodynamics Toward Pharmaceutical Problem Solving

19 A General Framework for Solid–Liquid Equilibria in Pharmaceutical Systems

20 Drug Solubility, Reaction Thermodynamics, and Co-Crystal Screening

21 Thermodynamic Modeling of Aqueous and Mixed Solvent Electrolyte Systems

22 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems

23 Toward a Rational Solvent Selection for Conformational Polymorph Screening

PART VII CRYSTALLIZATION AND FINAL FORM

24 Crystallization Design and Scale-Up

25 Introduction to Chiral Crystallization in Pharmaceutical Development and Manufacturing

26 Measurement of Solubility and Estimation of Crystal Nucleation and Growth Kinetics  

27 Case Studies On Crystallization Scale-Up

28 Population Balance-Enabled Model for Batch and Continuous Crystallization Processes

29 Solid Form Development for Poorly Soluble Compounds

30 Multiscale Assessment of API Physical Properties in the Context of Materials Science Tetrahedron Concept

PART VIII SEPARATIONS, FILTRATION, DRYING AND MILLING

31 The Design and Economics of Large-Scale Chromatographic Separations

32 Membrane Systems for Pharmaceutical Applications

33 Design of Distillation and Extraction Operations

34 Case Studies On the Use of Distillation in the Pharmaceutical Industry

35 Design of Filtration and Drying Operations

36 Filtration Case Studies

37 Drying Case Studies

38 Milling Operations in the Pharmaceutical Industry

PART IX STATISTICAL MODELS, PAT, AND PROCESS MODELING APPLICATIONS

39 Experimental Design for Pharmaceutical Development

40 Multivariate Analysis in API Development

41 Probabilistic Models for Forecasting Process Robustness

42 Use of Process Analytical Technology (PAT) in Small Molecule Drug Substance Reaction Development

43 Process Modeling Applications Toward Enabling Development and Scale-Up: Chemical Reactions

PART X MANUFACTURING

44 Process Scale-Up and Assessment

45 Scale-Up Do’s and Don’ts

46 Kilo Lab and Pilot Plant Manufacturing

47 The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients

PART XI QUALITY BY DESIGN AND REGULATORY

48 Scientific Opportunities through Quality by Design

49 Applications of Quality Risk Assessment in Quality by Design (QbD) Drug Substance Process Development

50 Development of Design Space for Reaction Steps: Approaches and Case Studies for Impurity Control

INDEX

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