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Full Description
How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics is an essential guide providing a comprehensive roadmap for transitioning complex injectable formulations from the laboratory to clinical applications. Offering an in-depth exploration of various complex injectables, including liposomal dosage forms, nanoparticles, and microspheres, this book delves into the principles of dosage form design, excipient selection, stability studies, and optimization techniques. Readers will gain valuable insights into ensuring the stability, efficacy, and safety of injectables during the scale-up process, as well as strategies for maintaining product quality and consistency from lab-scale to commercial-scale production. The book thoroughly examines manufacturing technologies such as aseptic processing, sterile filtration, and lyophilization, and their applications in producing complex injectables. Detailed discussions on quality control measures, analytical techniques, and quality assurance practices are provided to ensure the consistent quality and purity of injectables 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. Discussions on Good Manufacturing Practices (GMP) and regulatory submissions underscore the importance of compliance in achieving successful product development. 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.
Contents
1. Complex injectable dosage forms: A comprehensive exploration of diverse dosage form
2. Liposome based complex injectables: A note on scale-up processes
3. Microspheres based complex injectables: Development, characterization and scale-up methodology
4. Protein/peptide-drug conjugates: Design, synthesis and scale-up strategies of complex injectables
5. Polymer based nanoparticles: Design and development of dosage forms for clinical use
6. Micellar nanoformulations for parenteral delivery: Design, development and scale-up feasibilities
7. Nanosuspension based injectable dosage forms: State of art in taking them from bench to bedside
8. Nanoemulsion based injectable dosage forms: Design, development and scale-up strategies
9. Metallic nanoparticles based injectables: Development and scale-up strategies
10. Lipid based nanoparticles: A journey of injectable dosage forms from laboratory to clinics
11. Drug Complexes: Development and scale-up strategies of injectable dosage forms
12. Safeguarding quality: A deep dive into Regulatory and compendial standards for complex injectable dosage forms
