Description: 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.Brief description:
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.