Pharmaceutical Engineering: A Primer for Advanced Process Development

Pharmaceutical Engineering: A Primer for Advanced Process Development. Volume Two: Solid Dosage form Process Design provides a comprehensive, engineering-focused description of pharmaceutical dosage form process development and manufacturing. The set is split into two volumes where Volume One focuses on liquids and Volume Two on solids. Each volume introduces the most commonly used manufacturing processes for pharmaceutical dosage forms and addresses critical formulation and process parameters that influence drug product process performance and product quality. This is supplemented with detailed descriptions of engineering models as well as tools that can be used to support their development and verification (such as process analytical technology (PAT)) as well as the appropriate utilization of process and equipment knowledge. Typical scale-up challenges inspired by real industrial examples will be presented as well as a review of the latest correlations, theories and models that can form the basis for science-based scale-ups and transfers. Features engineering principles of pharmaceutical drug product processesIncludes development and scale-up of pharmaceutical drug product processesDefines a robust process via science and engineering-based principles INDICE: Section 1: The Basics 1. Introduction (Noor Al-Rifai, Ashish Kumar and Rene Holm) 2. General introduction to the field of drug product design and development, including current challenges and recent trends. 3. Regulatory considerations for pharmaceutical process development (Rene Holm) 4. A description of ICH Q8 (R2) in the relevant context, including process requirements, QbD options and experimental/computational approaches, as well as a description of pharmaceutical process validation. 5. Engineering fundamentals 6. The basic components needed to understand and build an engineering approach to a pharmaceutical drug product process, including and not limited to: material and energy balances, heat and mass transfer, dimensional analysis, flow of fluids and powders, scale-up approaches and workflows. This will be an introductory chapter and will be covered in more detail in section 2. 7. In process analysis (Jukka Rantanen, KU) 8. A description of some of the general analytical options that can be used for experimental characterization of drug product processes and the link to subsequent chapters, including the PAT regulatory status. The analytical principles behind common measurements across the different unit operations will be presented here. Section 2: Unit Operations 9. Mixing of solids (Eric Maynard - Jenike & Johanson; Richard Elkes - GSK) 10. Dry milling (Michael Juhnke - Novartis; Arno Kwade - TU Braunschweig; Ecevit Bilgili - NJYT) 11. Granulation (Stephen Sirabian - Glatt) 12. Roller compaction (Richard Elkes - GSK) 13. High shear granulation 14. Fluid bed granulation 15. Hot melt granulation 16. Extrusion and spheronisation 17. Drying - fluid bed or pan (Krist Gernaey - Danish Technical University) 18. Spray drying (Sune Andersen - Janssen; Hovione; Reinhard Vehring - University of Alberta; Andrey Bayly - University of Leeds) 19. Tabletting (Ashisk Kumar - Ghent University/Janssen; Richard Elkes - GSK) 20. Film coating of tablets - fluid bed or pan (Martin de Juan - AZ) 21. Capsule filling - powder (Eva Faulhammer - Research Center Pharmaceutical Engineering, Graz) 22. Continuous Manufacturing (Ashish Kumar - Ghent University / Janssen)

• ISBN: 978-0-443-15696-0
• Editorial: Elsevier
• Encuadernacion: Rústica
• Páginas: 500
• Fecha Publicación: 01/12/2024
• Nº Volúmenes: 1
• Idioma: Inglés