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Predictive Modeling of Pharmaceutical Unit Operations.
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Kent :
Elsevier Science,
2016.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; Predictive Modeling of Pharmaceutical Unit Operations; Copyright Page; Contents; List of contributors; Predictive modeling of pharmaceutical unit operations; Preface; 1 Modeling of drug product manufacturing processes in the pharmaceutical industry; 1.1 Introduction; 1.2 Modeling techniques; 1.2.1 First principle predictive models; 1.2.1.1 Discrete element method; 1.2.1.2 Computational fluid dynamics; 1.2.1.3 Finite element method; 1.2.1.4 Hybrid models; 1.2.1.5 Empirical models; 1.3 Process modeling in drug product manufacturing; 1.3.1 Problem statement.
- 1.3.2 Modeling technique selection1.3.3 Model development; 1.3.4 Model verification and validation; References; 2 Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations; 2.1 Introduction; 2.2 Quality risk management in pharmaceutical manufacturing; 2.2.1 Managing risk to quality; 2.2.2 Utilization of models to support quality risk management; 2.2.2.1 Sensitivity analysis: a risk assessment tool; 2.2.2.2 Feasibility analysis: a tool to evaluate risk mitigation strategies.
- 2.3 Scientific considerations in model development for quality risk management2.3.1 High-impact models; 2.3.2 Medium-impact models; 2.3.3 Low-impact models; 2.4 Using process models to support quality risk management for emerging technologies; 2.4.1 Risk assessment case studies for continuous manufacturing; 2.4.1.1 Continuous direct compression risk assessment: a case study; 2.4.1.2 End-to-end risk assessment: a case study; 2.4.2 Risk mitigation case studies for continuous manufacturing; 2.5 Conclusions; References; 3 Powder flow and blending.
- 3.1 Critical role of the powder blending step in pharmaceutical manufacturing3.2 Common challenges in powder blending; 3.3 Granular mixing fundamentals; 3.3.1 Mixing mechanisms; 3.3.2 Common techniques of mixing powders; 3.4 Assessment, measurement, and characterization; 3.4.1 Assessment; 3.4.2 Measurement; 3.4.3 Characterization; 3.5 Modeling techniques for powder mixing; 3.5.1 Development and usage of computational tools; 3.5.1.1 Techniques for modeling the underlying physics and processes; The DEM and its application to granular mixing.
- 3.5.1.2 Improvements in the efficiency of solution methods, algorithms, and compute architecture3.5.1.3 Advancement in analysis techniques with commercial and open source software; 3.5.2 Case study: creating a material model; 3.6 Summary and outlook; Acknowledgements; References; 4 Dry granulation process modeling; 4.1 Introduction; 4.2 Challenges in dry granulation modeling and recent progress; 4.2.1 Roller compaction technology; 4.2.2 Theoretical background; 4.2.3 Common problems of roller compaction and progress; 4.3 Modeling tools; 4.3.1 DEM modeling; 4.3.2 FEM modeling.