How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms
From Bench to the Clinics
- 1st Edition - February 1, 2026
- Imprint: Academic Press
- Editors: Neelam Poonia, Jitender Madan, Deepti Pandita
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 4 0 3 6 6 - 8
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 4 0 3 6 7 - 5
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 transi… Read more
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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.
- 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
Industry Professionals and researchers: Personnel working in the pharmaceutical and healthcare industries, as well as those involved in drug development
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
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
- Edition: 1
- Published: February 1, 2026
- Imprint: Academic Press
- Language: English
NP
Neelam Poonia
Dr. Poonia has over 13 years of teaching and research experience. She has supervised 13 post-graduate research projects. She has 17 publications in national and international journals of repute and book chapters to her credit with a h and i-10 index of 10 and 11, respectively. She has also presented her research at various national and international conferences. Dr. Poonia has been working on the development of targeted nanosystems for delivery of anticancer agents. Her key areas of research include development of nanotechnology-based drug delivery systems viz. solid lipid nanoparticles, nanostructured lipid carriers, mesoporous silica nanoparticles, etc. for combating solubility, stability, toxicity and
MDR-related issues associated with drugs.Affiliations and expertise
Chandigarh University, IndiaJM
Jitender Madan
Dr. Jitender Madan’s major areas of research include self-assembled supramolecular systems - liposomes, niosomes, cyclodextrin, nano- and micro-particles and solid-lipid nanoparticles. His focus is on the exploitation of US FDA approved biomaterials in combination with other potential lipids and polymers to develop the innovative dosage forms and drug delivery systems in order to improve the bioavailability, stability, safety (tolerance) and patient-compliance. While a wide range of applications are being considered, special emphasis has been given to augment the aqueous solubility and bioavailability of anticancer drugs as well as on the design, synthesis and development of ligand conjugated stealth nanoconstructs for delivery and targeting of anticancer drugs in cancer cells both in vitro and in vivo.
Affiliations and expertise
Associate Professor, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, IndiaDP
Deepti Pandita
Dr. Deepti Pandita is Professor in the Department of Pharmaceutics, DIPSAR, Delhi Pharmaceutical Science and Research University (DPSRU), New Delhi. She is Coordinator, Centre for Advanced Formulation and Technology (CAFT), a DSIR funded Centre; Coordinator, PhD Programme of DPSRU. Dr. Pandita has 20+ years of teaching and research experience, and previously was FCT Postdoctoral Fellow at University of Madeira, Portugal. Her key areas of research include nanomedicine & nanotheranostics, formulation development, drug discovery & repurposing, nano-mediated targeted delivery of phytochemicals.
Affiliations and expertise
Delhi Pharmaceutical Sciences and Research University, India