How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms

From Bench to the Clinics

Neelam Poonia, Jitender Madan, Deepti Pandita

• Publisher: Academic Press
• Year: 2026
• eBook ISBN:
  9780443403675
• Topic: Medicine
• Subtopic: Pharmaceutical, Biotechnology & Healthcare Industry

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. - Provides comprehensive guidance on scaling-up complex injectables from lab to clinical applications - Offers in-depth insights into dosage form design, excipient selection, and stability studies - Explores advanced manufacturing technologies and quality control measures for consistent product quality - Highlights regulatory requirements and best practices for compliance with GMP and regulatory submissions - Includes successful examples and practical insights from industry experts and leading researchers

Table of contents

• Front Cover
• How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics
• Copyright Page
• Contents
• List of contributors
• About the series
• About the editors
• 1 Complex injectable dosage forms: a comprehensive exploration of diverse dosage forms
• 2 Liposome-based complex injectables: a note on scale-up processes
• 3 Microsphere-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 strategiesTwo title details are present in this chapter, follow first and remove second "Chapter 8 Nanoemulsion-based Injectable Dosage Forms: Design, Development and Scale-up Strategies" Please confirm which title details is correct.-->Please check the inserted shortened Running Head and kindly correct if necessary.-->Please note that your manuscript has been copyedited for grammar and punctuation as well as Elsevier house style requirements. These edits may include adjustments to spelling, hyphenation, standard nomenclature, and stylistic formatting.-->Please check the chapter title and amend if necessary.-->
• 9 Metallic nanoparticle-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
• Index
• Back Cover