Process understanding [[electronic resource] ] : for scale-up and manufacture of active ingredients / / edited by Ian Houson

• Pubblicazione: Weinheim, Germany, : Wiley-VCH, 2011
• Descrizione fisica: 1 online resource (371 p.)
• Disciplina: 004.3; 660.28
• Soggetto topico: Drugs - Design; Pharmaceutical microbiology; Drugs - Analysis
• Altri autori: HousonI. N (Ian N.)
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: Process Understanding; Contents; Preface; List of Contributors; 1 Quality by Design; 1.1 History; 1.2 Defining Product Design Requirements and Critical Quality Attributes; 1.3 The Role of Quality Risk Management in QbD; 1.4 Design Space and Control Strategy; 1.5 Quality Systems; References; 2 Route and Process Selection; 2.1 Introduction; 2.2 Route Evaluation; 2.3 Factors to Consider; 2.3.1 Timing; 2.3.2 Costs; 2.3.2.1 Removal of a Chromatography Step; 2.3.3 Safety, Health, and Environment (SHE); 2.3.3.1 Safer Processes; 2.3.3.2 Green Chemistry; 2.3.4 Legal; 2.3.5 Other Considerations ; 2.3.5.1 Throughput2.3.5.2 Solvents; 2.3.5.3 Raw Materials; 2.3.5.4 Intermediates; 2.4 Route Selection; 2.4.1 Sildenafil; 2.5 Process Selection; 2.5.1 Pregabalin; 2.5.2 NK1 Receptor Antagonist; 2.5.3 Data; 2.6 Summary; References; 3 Critical Stages of Safety Assessment in Process Design and Scale-Up; 3.1 Reaction Safety Concepts; 3.1.1 What Is the Hazard?; 3.1.2 The Critical Effects of Scale-Up on Thermal Behavior; 3.1.3 Safety Features of a Reaction; 3.1.4 Stages of Safety Assessment; 3.2 Pre-Laboratory Safety Studies; 3.2.1 Predicting Reaction Safety Characteristics ; 3.2.2 Selecting Inherently Safer Processing Conditions3.3 The Synergies of Safety and Optimization - Together; 3.3.1 Testing of Potentially Explosive Compounds; 3.3.2 Thermal Stability Assessment; 3.3.3 Reaction Thermodynamic, Kinetic, and Gas-Generation Quantification; 3.3.4 Developing Fault-Tolerant Processes - by Design; 3.4 Establishing a Reliable Basis of Safety for Scale-Up; 3.4.1 Hazardous Scenario Identification; 3.4.2 Determining the Consequences of Hazardous Scenarios; 3.4.3 Experimental Simulation - Adiabatic Calorimetry; 3.4.4 Specify and Implement Safety Measures ; 3.4.5 Large-Scale Production3.5 Flammability Hazards; 3.5.1 Assessing Pilot-Scale Flammability Hazards; 3.6 Summary; References; 4 Understanding the Reaction; 4.1 Introduction; 4.2 Process Complexity; 4.2.1 Number of Phases; 4.2.2 Physical and Dynamic Complexity; 4.2.2.1 Length Scales; 4.2.2.2 Time; 4.2.2.3 Solubility; 4.2.2.4 Density; 4.2.2.5 Rheology; 4.2.2.6 Heat Transfer; 4.2.2.7 Mass Transfer/Interfacial Area; 4.2.2.8 Mixing Time; 4.2.3 Chemical Complexity; 4.3 Topics for Data Acquisition; 4.4 Reaction Profiles; 4.5 Reaction Pictures; 4.6 Ionic Equilibria and Reaction Selectivity ; 4.6.1 Nitration4.6.2 Acylation; 4.6.3 Association Equilibria - Lithium Diethylamide (LDA); 4.7 Kinetics; 4.7.1 Order of Reaction; 4.8 Catalyzed Processes; 4.9 The Rate-Determining Step; 4.10 Mixing in Chemical Reactors; 4.11 Mixing Theory; 4.11.1 Mixing Regimes; 4.11.2 Micromixing; 4.11.3 Macromixing; 4.11.4 Mesomixing; 4.11.5 Determining Mixing Sensitivity in the Laboratory; 4.11.6 Comments on Scalability of Mixing; 4.12 Multiphase Processes; 4.13 Mass Transfer Theory; 4.13.1 Effect of Mass Transfer on Chemical Reaction Rates; 4.13.1.1 Chemical Rate-Limited Reaction ; 4.13.1.2 Mass Transfer Rate-Limited Reaction
• Sommario/riassunto: Process Understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA`s Food and Drug Administration. This book covers the multidisciplinary aspects required for successful process design, safety, modeling, scale-up, PAT, pilot plant implementation, plant design as well the rapidly expanding area of outsourcing. In discussing what process understanding means to differ
• Titolo autorizzato: Process understanding
• ISBN: 3-527-65036-9; 1-283-28330-1; 9786613283306; 3-527-63715-X; 3-527-63716-8; 3-527-63714-1
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910830235403321
• Lo trovi qui: Univ. Federico II