How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics
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.
1147841506
How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics
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.
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How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics

How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics

How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics

How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics

Overview

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.

Product Details

ISBN-13: 9780443403668
Publisher: Elsevier Science
Publication date: 02/01/2026
Series: Expertise in Pharmaceutical Process Technology
Pages: 400
Product dimensions: 6.00(w) x 9.00(h) x (d)

About the Author

Dr. Neelam Poonia is currently working as a Professor in University Institute of Pharma Sciences, Chandigarh University, Gharuan, Mohali, Punjab, India. She has over 14.8 years of academic and research experience and has supervised 15 postgraduate (M. Pharm) research projects. She completed her Ph.D. in Pharmaceutical Sciences from Punjab Technical University, Jalandhar (Punjab, India). Her areas of research specialization include the design and development of nanocarrier systems such as solid lipid nanoparticles (SLNs), nanostructured lipid carriers (NLCs), mesoporous silica nanoparticles, dendrimers, and nanoemulsions, aimed at addressing critical challenges such as poor solubility, low bioavailability, toxicity, and multidrug resistance (MDR) in therapeutic agents. She has authored 33 peer-reviewed publications in reputed national and international journals and book chapters. Her scholarly output has earned over 1,689 citations, with an h-index of 10 and an i10-index of 12. In recognition of her academic excellence, she was awarded the "Star Educator Award of the Year" by Chandigarh University in 2024. She is the reviewer of several peer reviewed journals.


Dr. Jitender Madan is currently working as a faculty in Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, Telangana, India at the position of Associate Professor. Dr. Jitender Madan has demonstrated an excellent level of expertise and dedication to both research and teaching. Dr. Jitender Madan completed his B.Pharmacy from Nagpur University, Nagpur (Maharashtra, India), M. Pharmacy (Pharmaceutical Biotechnology) from Department of Pharmaceutical Sciences, Dr. Hari Singh Gaur University, Saugar (Madhya Pradesh, India) and PhD (Pharmaceutical Sciences) from Institute of Pharmacy, Bundelkhand University, Jhansi (UttraPradesh, India). Later, he received postdoctoral position at Department of Biology, Georgia State University, Atlanta, GA, USA. A strong academic foundation allowed him to contribute significantly to the field of pharmaceutical sciences. Dr. Jitender Madan has supervised many M. Pharmacy (Pharmaceutics) and PhD (Pharmaceutical Sciences) students. Dr. Jitender Madan also contributed a lot in pharmaceutical product development. He has handled both Industry and Government funded projects. In addition, Dr. Jitender Madan has an impressive research portfolio. He has authored more than 130 peer-reviewed publications in international journals of repute, leading to an h-index of 35 and an i10-index of 88 with 3555 citations. He has also contributed approximately 50 book chapters in international books and holds many granted patents related to innovative processes and compositions aimed at enhancing therapeutic efficacy in topical, oral and intravaginal drug delivery. His scholarly work has earned him a place among the top 2% scientists worldwide in the field of Pharmacology and Pharmacy, according to global rankings compiled by Stanford University.


Dr. Deepti Pandita is Professor in the Department of Pharmaceutics, Delhi Institute of Pharmaceutical Sciences & Research (DIPSAR), Delhi Pharmaceutical Science and Research University (DPSRU), Govt. of NCT of Delhi, New Delhi. She is Member, Board of Governors & Finance Committee, DPSRU; Coordinator, PhD Section; Coordinator, Centre for Advanced Formulation and Technology (CAFT), a Department of Scientific and Industrial Research (DSIR) funded Common Research and Technology Development Hub (CRTDH); and Member, Academic Research Ethics Committee. She has done her PhD in Pharmaceutics from Jamia Hamdard, and post-graduation from Manipal University. Dr. Pandita has 22+ years of teaching and research experience, and previously was FCT Postdoctoral Fellow at University of Madeira, Portugal.

Dr. Deepti received major research grants from Government of India viz. All India Council for Technical Education (AICTE) and Science and Engineering Research Board (SERB)- Department of Science and Technology (DST), under Research Promotion and Young Scientist Schemes in 2012-14 and 2012-15 respectively and Best Pharmaceutical Scientist Award- 2014, Haryana State Branch, Association of Pharmaceutical Teachers of India (APTI). She has received grants for conducting Faculty Development Programmes, National & International Conferences and Workshops from AICTE and DST in 2013, 2014, and 2017-18.

Recently, she had received three major institutional grants from DSIR-CRTDH Scheme under Affordable Health Scheme, DST-FIST for Dept of Pharmaceutics, and Anusandhan National Research Foundation (ANRF)-Partnerships for Accelerated Innovation and Research (PAIR) grant as the Key Investigator. She has earned to her credit several book chapters and 150+ publications in peer-reviewed journals with high impact factor like Drug Resistance Updates, Journal of Controlled Release, Materials Science and Engineering: C, Trends in Food Technology, Drug Discovery Today, Molecular Pharmaceutics, Biomacromolecules, Nanotoxicology etc., leading to an h-index of 31 and an i10-index of 65 with 4528 citations. She also has two Indian Patents to her credit. She has guided/guiding 7 PhD and 56 PG scholars. Dr. Deepti has been included in Top 2 % of the most-cited scientists for FIVE consecutive years on the basis of database created by Stanford University, USA, since it was published. She is the reviewer of several peer reviewed journals.

Table of 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

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A comprehensive guide on scaling up complex injectable formulations, covering dosage design, manufacturing technologies, quality control, and regulatory compliance for successful clinical applications

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