How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics provides a comprehensive roadmap for transitioning complex injectable formulations from the laboratory to clinical applications. Offering an exploration of various complex injectables, including liposomal dosage forms, nanoparticles, and microspheres, this book delves into dosage form design, excipient selection, stability studies, and optimization techniques. The book examines manufacturing technologies such as aseptic processing, sterile filtration, and lyophilization, and their applications in producing complex injectables. Discussions on quality control measures, analytical techniques, and quality assurance practices are provided to ensure consistent quality and purity throughout the manufacturing process.
Readers will benefit from the expert knowledge and practical insights shared by industry professionals and leading researchers, including successful examples of marketed complex injectables. Highlighting best practices and regulatory requirements, this book offers a comprehensive overview of the guidelines for the development, manufacturing, and commercialization of complex injectables. Ideal for pharmaceutical scientists, formulation developers, and regulatory professionals, this book is a valuable resource for anyone involved in the scale-up and commercialization of complex injectable dosage forms.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. List of contributors - p. xv 7. About the series - p. xix 8. About the editors - p. xxi 9. Chapter 1. Complex injectable dosage forms: a comprehensive exploration of diverse dosage forms - p. 1 10. Chapter 2. Liposome-based complex injectables: a note on scale-up processes - p. 19 11. Chapter 3. Microsphere-based complex injectables: development, characterization, and scale-up methodology - p. 61 12. Chapter 4. Protein/peptide–drug conjugates: design, synthesis, and scale-up strategies of complex injectables - p. 85 13. Chapter 5. Polymer-based nanoparticles: design and development of dosage forms for clinical use - p. 107 14. Chapter 6. Micellar nanoformulations for parenteral delivery: design, development, and scale-up feasibilities - p. 127 15. Chapter 7. Nanosuspension-based injectable dosage forms: state of art in taking them from bench to bedside - p. 147 16. Chapter 8. Nanoemulsion-based injectable dosage forms: design, development, and scale-up strategies - p. 221 17. Chapter 9. Metallic nanoparticle-based injectables: development and scale-up strategies - p. 275 18. Chapter 10. Lipid-based nanoparticles: a journey of injectable dosage forms from laboratory to clinics - p. 307 19. Chapter 11. Drug complexes: development and scale-up strategies of injectable dosage forms - p. 345 20. Index - p. 365
How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics provides a comprehensive roadmap for transitioning complex injectable formulations from the laboratory to clinical applications. Offering an exploration of various complex injectables, including liposomal dosage forms, nanoparticles, and microspheres, this book delves into dosage form design, excipient selection, stability studies, and optimization techniques. The book examines manufacturing technologies such as aseptic processing, sterile filtration, and lyophilization, and their applications in producing complex injectables. Discussions on quality control measures, analytical techniques, and quality assurance practices are provided to ensure consistent quality and purity throughout the manufacturing process.
Readers will benefit from the expert knowledge and practical insights shared by industry professionals and leading researchers, including successful examples of marketed complex injectables. Highlighting best practices and regulatory requirements, this book offers a comprehensive overview of the guidelines for the development, manufacturing, and commercialization of complex injectables. Ideal for pharmaceutical scientists, formulation developers, and regulatory professionals, this book is a valuable resource for anyone involved in the scale-up and commercialization of complex injectable dosage forms.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. List of contributors - p. xv 7. About the series - p. xix 8. About the editors - p. xxi 9. Chapter 1. Complex injectable dosage forms: a comprehensive exploration of diverse dosage forms - p. 1 10. Chapter 2. Liposome-based complex injectables: a note on scale-up processes - p. 19 11. Chapter 3. Microsphere-based complex injectables: development, characterization, and scale-up methodology - p. 61 12. Chapter 4. Protein/peptide–drug conjugates: design, synthesis, and scale-up strategies of complex injectables - p. 85 13. Chapter 5. Polymer-based nanoparticles: design and development of dosage forms for clinical use - p. 107 14. Chapter 6. Micellar nanoformulations for parenteral delivery: design, development, and scale-up feasibilities - p. 127 15. Chapter 7. Nanosuspension-based injectable dosage forms: state of art in taking them from bench to bedside - p. 147 16. Chapter 8. Nanoemulsion-based injectable dosage forms: design, development, and scale-up strategies - p. 221 17. Chapter 9. Metallic nanoparticle-based injectables: development and scale-up strategies - p. 275 18. Chapter 10. Lipid-based nanoparticles: a journey of injectable dosage forms from laboratory to clinics - p. 307 19. Chapter 11. Drug complexes: development and scale-up strategies of injectable dosage forms - p. 345 20. Index - p. 365
