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Practical guide to hot-melt extrusion : continuous manufacturing and scale-up.
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Smithers Rapra,
2015.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Preface; Contents; Contributors; 1 Introduction to Hot-Melt Extrusion, Continuous Manufacturing: Scale-up via Hot-Melt Extrusion; 1 Background; 1.1 Introduction; 1.1.1 Hot-Melt Extrusion Process Technology; 1.1.2 Equipment; 1.1.3 Benefits and Drawbacks to Hot-Melt Extrusion; 1.1.4 Application of Hot-Melt Extrusion; 1.1.5 Materials used in Hot-Melt Extrusion Processes; 1.1.6 Development of Sustained-release Formulations; 1.1.7 Marketed Products; 1.2 Continuous Manufacturing; 1.3 Scale-up via Hot-Melt Process; 1.3.1 Case Study: Scale-up of a Hot-Melt Extrusion Process using Soluplus as Carrier.
- 1.4 ConclusionsReferences; 2 Hot-Melt Extrusion as Continuous Manufacturing Technique, Current Trends and Future Perspectives; 2.1 Hot-Melt Extrusion as Continuous Manufacturing Technique; 2.1.1 Hot-Melt Extrusion Equipment; 2.1.2 Single-screw Extruder; 2.1.3 Twin-screw Extruders; 2.1.4 Role of Glass Transition Temperature; 2.1.5 Role of Mechanical Parameters; 2.1.6 Use of Plasticisers or Surfactants; 2.1.7 Challenges and Opportunities; 2.2 Background Information on Batch Processing; 2.2.1 Past and Future Trends of Continuous Manufacturing; 2.2.2 Conventional Batch Process Design.
- 2.2.3 Production Parameters2.2.4 Production Parameters in Batch Processing; 2.2.4.1 Active Pharmaceutical Ingredient(s) Manufacturing Site; 2.2.4.2 Formulation Development; 2.2.4.3 Industrial Scale-up; 2.2.4.4 Regulatory Guidelines; 2.2.5 Validation of Batch Processing; 2.2.6 In-line Continuous Monitoring Techniques; 2.3 Assimilation of Complete Quality-by-Design Models; 2.3.1 Chief Modification in Procedural Expertise for Continuous Manufacturing; 2.3.2 Process Parameters for Preformulation for Hot-Melt Extrusion; 2.3.3 Implementation of a New Product Development Process.
- 2.3.3.1 Modelling Simulation of Hot-Melt Extrusion Process2.3.4 Flow Chart Model for Continuous Hot-Melt Extrusion based Pharmaceutical Manufacturing Process; 2.3.5 Foremost Alteration in Structural Provisions for Quality and Technical Operations; 2.3.6 Potential Benefits of Continuous Hot-Melt Extrusion Manufacturing; 2.3.7 Regulatory Issues Related to Hot-Melt Extrusion; 2.3.8 Process Analytical Technology Framework; 2.4 Conclusion; References; 3 Co-extrusion as a Novel Approach in Continuous Manufacturing Compliance; 3 Background; 3.1 Introduction.
- 3.2 Applications of Co-extrusion via Hot-Melt Extrusion in Continuous Manufacturing3.2.1 Problem Encountered During Co-extrusion; 3.2.2 Variation of the Die Temperature; 3.2.3 Swelling of the Die; 3.2.4 Viscosity Matching; 3.2.5 Adhesion; 3.2.6 Interdiffusion; 3.2.7 Delamination; 3.3 Pharmaceutical Applications; 3.3.1 Pharmaceutical Significance of the Co-extrusion Technique; 3.4 Case Study; 3.5 Conclusions; References; 4 Solid-state Engineering of Drugs using Melt Extrusion in Continuous Process; 4 Introduction; 4.1 Dissolution Enhancement; 4.1.1 Use of Novel Inorganic Excipients.