| Description |
1 online resource (381 pages) |
| Contents |
Cover -- Title Page -- Copyright Page -- Contents -- Preface -- Chapter 1 Introduction to Crystallization -- 1.1 Crystal Properties and Polymorphs (Chapters 2 and 3) -- 1.2 NUCLEATION AND GROWTH KINETICS (CHAPTER 4) -- 1.3 MIXING AND SCALE-UP (CHAPTER 5) -- 1.4 Critical Issues and Quality by Design (Chapter 6) -- 1.4.1 Critical Issues -- 1.4.2 Design of Experiment -- 1.5 Crystallization Process Options (Chapters 7-10) -- 1.5.1 Cooling (Chapter 7) -- 1.5.2 Evaporation Solvent (Chapter 8) -- 1.5.3 Antisolvent Addition (Chapter 9) -- 1.5.4 Reactive Crystallization (Chapter 10) -- 1.6 Downstream Operations (Chapters 11 And 12) -- 1.7 Special Applications (Chapter 13) -- Chapter 2 Properties -- 2.1 Solubility -- 2.1.1 Free Energy-Composition Phase Diagram -- 2.1.2 Temperature -- 2.1.3 Solvent -- 2.1.4 Impurities -- 2.1.5 Chemical and Physical Structure, Salt and Co-Crystal Form -- 2.1.6 Solubility Measurement and Prediction -- 2.1.7 Significance of Crystallization -- 2.2 Supersaturation, Metastable Zone, and Induction Time -- 2.2.1 Free Energy-Composition Phase Diagram -- 2.2.2 Factors Affecting Metastable Zone Width and Induction Time -- 2.2.3 Measurement and Prediction -- 2.2.4 Significance of Crystallization -- 2.3 Oil, Amorphous, and Crystalline States -- 2.3.1 Phase Diagram -- 2.3.2 Measurement -- 2.3.3 Significance to Crystallization -- 2.4 Polymorphism -- 2.4.1 Phase Diagram -- 2.4.2 Measurement and Prediction -- 2.4.3 Significance to Crystallization and Downstream Operations -- 2.5 Solvate -- 2.5.1 Phase Diagram -- 2.5.2 Measurement and Prediction -- 2.5.3 Significance to Crystallization and Downstream Operations -- 2.6 Solid Compound, Solid Solution, and Solid Mixture -- 2.6.1 Phase Diagram -- 2.6.2 Measurement and Prediction -- 2.6.3 Significance to Crystallization -- 2.7 Inclusion and Occlusion -- 2.7.1 Mechanism -- 2.7.2 Measurement |
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2.7.3 Significance to Crystallization and Downstream Operations -- 2.8 Adsorption, Hygroscopicity, and Deliquesce -- 2.8.1 Phase Diagram -- 2.8.2 Measurement -- 2.8.3 Significance to Crystallization and Downstream Operations -- 2.9 Crystal Morphology -- 2.9.1 General Observations -- 2.9.2 Measurement and Prediction -- 2.9.3 Significance to Crystallization and Downstream Operations -- 2.10 Partical Size Distribution and Surface Area -- 2.10.1 Particle Distribution Definition -- 2.10.2 Measurement -- 2.10.3 Significance to Crystallization and Downstream Operations -- Chapter 3 Polymorphism -- 3.1 Phase Rule -- 3.2 Phase Transition -- 3.2.1 Enantiotropy and Monotropy -- 3.2.2 Metastable Equilibrium and Suspended Transformation -- 3.2.3 Measurement -- 3.3 Prediction of Crystal Structure and its Formation -- 3.3.1 Equilibrium Approach -- 3.3.2 Kinetic Approach -- 3.4 Selection and Screening of Crystal Forms -- 3.4.1 Selection Criteria -- 3.4.2 Candidates for Forming Salts and Co-crystals -- 3.4.3 High Throughput and Process-Based Screening -- 3.5 Examples -- EXAMPLE 3.1 -- EXAMPLE 3.2 -- EXAMPLE 3.3 -- EXAMPLE 3.4 -- EXAMPLE 3.5 -- EXAMPLE 3.6 -- EXAMPLE 3.7 -- EXAMPLE 3.8 -- EXAMPLE 3.9 -- Chapter 4 Kinetics -- 4.1 SUPERSATURATION AND RATE PROCESSES -- 4.2 Nucleation -- 4.2.1 Homogeneous Nucleation -- 4.2.2 Heterogeneous Nucleation -- 4.2.3 Secondary Nucleation -- 4.3 Crystal Growth and Agglomeration -- 4.3.1 Crystal Growth Mechanisms -- 4.3.2 Agglomeration Mechanism -- 4.3.3 Measurement of Crystal Growth Rate -- 4.3.4 Crystal Population Balance -- 4.4 Nucleate/Seed Aging and Ostwald Ripening -- 4.5 DELIVERED PRODUCT: PURITY, CYSTAL FORM, SIZE AND MORPHOLOGY, AND CHEMICAL and PHYSICAL STABILITY -- 4.6 Design of Experiment (DOE)-Model-Based Approach -- 4.7 Model-Free Feedback Control -- Chapter 5 Mixing and Crystallization -- 5.1 INTRODUCTION |
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5.2 Mixing Considerations and Factors -- 5.2.1 Mixing Time -- 5.2.2 Mixing Intensity -- 5.2.3 Mixing Distribution -- 5.3 Mixing Effects on Nucleation -- 5.3.1 Primary Nucleation -- 5.3.2 Secondary Nucleation and Particle Breakage -- 5.3.3 Damkoehler Number for Nucleation -- 5.3.4 Scale-Up of Nucleation-Based Processes -- 5.4 Mixing Effects on Crystal Growth -- 5.4.1 Mass Transfer Rate -- 5.4.2 Da Number for Crystallization -- 5.4.3 Conflicting Mixing Effects -- 5.4.4 Experimentation on Mixing Effects -- 5.4.5 Effects of Mixing on PSD -- 5.5 Mixing Distribution and Scale-Up -- 5.5.1 Power -- 5.5.2 Off-Bottom Suspension -- 5.6 Crystallization Equipment -- 5.6.1 Stirred Vessels -- 5.6.2 Fluidized Bed Crystallizer -- 5.6.3 Impinging Jet Crystallizer -- 5.7 Process Design and Examples -- EXAMPLE 5.1 -- EXAMPLE 5.2 -- Chapter 6 Critical Issues and Quality by Design -- 6.1 Quality By Design -- 6.2 Basic Properties -- 6.2.1 Solubility and Crystal Forms -- 6.2.2 Particle Size and Morphology -- 6.3 Seed -- 6.3.1 Determination of Seed Form, Size, and Quantity -- 6.3.2 Effectiveness of Seeding -- 6.4 Supersaturation -- 6.4.1 Generation of Supersaturation -- 6.4.2 Oiling Out, Agglomeration/Aggregation -- 6.4.3 Nucleation -- 6.4.4 Crystal Growth -- 6.5 Mixing and Scale-Selection of Equipment and Operating Procedures -- 6.5.1 Stirred Vessels -- 6.5.2 In-line Mixers -- 6.5.3 Fluidized Bed -- 6.6 Strategic Considerations for Crystallization Process Development -- 6.7 Summary of Critical Issues -- Chapter 7 Cooling Crystallization -- 7.1 Batch Operation -- 7.1.1 Rate of Cooling -- 7.1.2 Metastable Region -- 7.1.3 Seeding Versus Spontaneous Nucleation -- 7.1.4 Mixing and Mass Transfer -- 7.1.5 Solvent -- 7.1.6 Impurities (Dissolved and Undissolved) -- 7.2 Continuous Operations -- 7.2.1 The Attraction of Continuous Processing |
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7.2.2 Operating Strategy for Continuous Cooling Crystallizers -- 7.2.3 Plug Flow and Cascade Operation -- 7.2.4 Fluidized Bed Continuous Cooling Crystallizer Designs -- 7.3 Process Design-Examples -- EXAMPLE 7.1 -- EXAMPLE 7.2 -- EXAMPLE 7.3 -- EXAMPLE 7.4 -- EXAMPLE 7.5 -- EXAMPLE 7.6 -- Chapter 8 Evaporative Crystallization -- 8.1 INTRODUCTION -- 8.2 Solubility Diagrams -- 8.2.1 Increasing Solubility -- 8.2.2 Decreasing Solubility -- 8.2.3 Change in Solvent -- 8.3 FACTORS AFFECTING NUCLEATION AND GROWTH -- 8.4 Scale-Up -- 8.5 Equipment -- 8.5.1 Heat Transfer -- 8.5.2 Overconcentration -- 8.5.3 Combination of Evaporation and Cooling -- 8.6 Process Design and Examples -- EXAMPLE 8.1 -- EXAMPLE 8.2 -- EXAMPLE 8.3 -- Chapter 9 Anti-solvent Crystallization -- 9.1 Operation -- 9.1.1 Normal Mode of Addition -- 9.1.2 Reverse Addition -- 9.1.3 Simultaneous Mode of Addition -- 9.1.4 Addition Strategy -- 9.1.5 Seeding -- 9.2 IN-LINE MIXING CRYSTALLIZATION -- 9.3 Process Design and Examples -- EXAMPLE 9.1 -- EXAMPLE 9.2 -- EXAMPLE 9.3 -- EXAMPLE 9.4 -- EXAMPLE 9.5 -- EXAMPLE 9.6 -- EXAMPLE 9.7 -- Chapter 10 Reactive Crystallization -- 10.1 INTRODUCTION -- 10.1.1 Utilization -- 10.1.2 Literature -- 10.2 Control of Particle Size -- 10.2.1 Controlling for Growth -- 10.3 Key Issues in Organic Reactive Crystallization -- 10.3.1 Mixing Issues -- 10.3.2 Mixing and Growth -- 10.3.3 Induction Time and Nucleation -- 10.3.4 Supersaturation Control -- 10.3.5 Seeding -- 10.3.6 Crystal Growth -- 10.3.7 Impurities/Additives -- 10.3.8 Secondary Effects -- 10.4 Creation of Fine Particles-In-Line Reactive Crystallization -- 10.5 Process Design and Scale-Up -- EXAMPLE 10.1 -- EXAMPLE 10.2 -- EXAMPLE 10.3 -- EXAMPLE 10.4 -- Chapter 11 Filtration -- 11.1 INTRODUCTION -- 11.2 BASIC PROPERTIES -- 11.2.1 Particle Size -- 11.2.2 Filter Medium -- 11.2.3 Wash Solvents |
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11.2.4 Temperature -- 11.3 KINETICS -- 11.3.1 Filtrate Concentration Profile During Filtration/Washing -- 11.3.2 Filtration and Cake Wash Protocol -- 11.3.3 Filtration Model -- 11.3.4 Settling Rate vs Filtration Rate -- 11.4 process design and scale-up -- 11.4.1 Agitated Filter Dryer -- 11.4.2 Centrifuge Filter -- 11.4.3 Other Operation Complications -- Chapter 12 Drying -- 12.1 INTRODUCTION -- 12.2 BASIC PROPERTIES -- 12.2.1 Vapor-Liquid Equilibrium -- 12.2.2 Solvation and Desolvation -- 12.2.3 Hardness and Brittleness of Solid Particles -- 12.2.4 Agglomerates and Granules of Solid Particles -- 12.3 KINETICS -- 12.3.1 Drying Profiles -- 12.3.2 Particle Fracture and Agglomeration -- 12.3.3 Inter-Relationship Between Drying Stage and Particle Behavior -- 12.4 PROCESS DESIGN AND SCALE-UP -- 12.4.1 Process Design -- 12.4.2 Scale-up -- Chapter 13 Special Applications -- 13.1 INTRODUCTION -- 13.2 CRYSTALLIZATION WITH SUPERCRITICAL FLUIDS -- 13.3 Resolution of Stereo-Isomers -- 13.3.1 Option 1: Use of a Chiral Additive to Create a Diastereoisomeric Set of Compounds -- 13.3.2 Option 2: Chiral Chemistry to Improve Reaction Chiral Selectivity of the Desired Isomer -- 13.3.3 Option 3: Kinetic and Dynamic Resolution -- 13.3.4 Option 4: Use of Chromatography, Membrane, Enzyme, or Other Separation Technology -- 13.4 WET MILLS IN CRYSTALLIZATION -- 13.5 COMPUTATIONAL FLUID DYNAMICS IN CRYSTALLIZATION -- 13.6 Solid Dispersion-Crystalline and/or Amorphous Drugs -- 13.7 Process Design and Examples -- EXAMPLE 13.1 -- EXAMPLE 13.2 -- EXAMPLE 13.3 -- EXAMPLE 13.4 -- EXAMPLE 13.5 -- EXAMPLE 13.6 -- EXAMPLE 13.7 -- References -- Index -- EULA |
| Notes |
Description based on publisher supplied metadata and other sources |
| Form |
Electronic book
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| Author |
Paul, Edward L
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Midler, Michael
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McCauley, James A
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| ISBN |
1119879493 |
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9781119879497 |
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1119879477 |
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9781119879473 |
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