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 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

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 serves as Associate Professor in the Department of Pharmaceutics at NIPER Hyderabad, where he integrates research leadership with graduate-level teaching. He holds a B.Pharmacy from Nagpur University, an M.Pharmacy in Pharmaceutical Biotechnology from Dr. Hari Singh Gour University, and a PhD in Pharmaceutical Sciences from Bundelkhand University; he pursued a postdoctoral fellowship at Georgia State University. He has built a substantial research program in pharmaceutical sciences, mentoring many M. Pharmacy and PhD scholars and contributing to pharmaceutical product development. His leadership has spanned industry and government-funded projects. His scholarly portfolio includes extensive publication in international journals, numerous book chapters, and multiple granted patents pertaining to innovative delivery systems for topical, oral, and intravaginal therapies. His work has earned broad recognition in global rankings within pharmacology and pharmacy.

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.