Neelesh Kumar Mehra – författare

Dendrimers, hyperbranched macromolecules, emerged just few decades ago but show promising potential as drug delivery nanocarriers, theranostic agents and gene vectors; in the pharmaceutical research and innovation area as well as in other healthcare applications. Although tremendous advancements have been made in dendrimer chemistry and their applications since their emergence, the synthesis, development and design of pure and safe dendrimer-based products have been a major challenge in this area.

This book, edited by well-known researchers in the area of nanomaterials and drug-based drug delivery applications, exhaustively covers the nanotechnological aspects, concepts, properties, characterisation, application, biofate and regulatory aspects of dendrimers. It includes sixteen vivid chapters by renowned formulators, researchers and academicians from all over the world, highlighting their specialised areas of interest in the fields of chemistry, biology, pharmacy and nanomedicine.

Features:

• Highlights dendrimers’ advancements in nanomedicine in the development of safe healthcare and biotechnological products

• Covers physicochemical aspects, biofate, drug delivery aspects and gene therapy using dendrimers

• Covers biomedical application of dendrimers in the field of biological sciences

• Gives examples of dendrimer–guest interaction chemistry

Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives provides the comprehensive overview of the latest research efforts in designing, optimising, development and scale-up of dendrimer-mediated delivery systems. It analyses the key challenges of synthesis, design, molecular modelling, fundamental concepts, drug delivery aspects, analytical tools and biological fate as well as regulatory consideration to the practical use of dendrimer application.

Dr. Neelesh Kumar Mehra Assistant Professor of Pharmaceutics in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He has authored more than sixty peer-reviewed publications in highly reputed international journals, as well as book chapters and contributions on two patents. Dr. Mehra has 11 years of rich research and teaching experience in the formulation and development of complex, innovative biopharmaceutical products including micro- and nanotechnologies for regulated markets.

Dr. Keerti Jain Assistant Professor of Pharmaceutics in the Department of Pharmaceutics, NIPER, Raebareli, India. For more than 10 years, she has been actively engaged in formulation and development of nanomedicines. Dr. Jain has supervised masters and doctoral pharmaceutics students in their research works which have been published in high quality, good impact factor journals. She has also authored more than 60 international manuscripts in peer reviewed high impact journals. In 2019, she was awarded the prestigious ICMR-Amir Shakuntala Award.

Dendrimers, hyperbranched macromolecules, emerged just few decades ago but show promising potential as drug delivery nanocarriers, theranostic agents and gene vectors; in the pharmaceutical research and innovation area as well as in other healthcare applications. Although tremendous advancements have been made in dendrimer chemistry and their applications since their emergence, the synthesis, development and design of pure and safe dendrimer-based products have been a major challenge in this area.

This book, edited by well-known researchers in the area of nanomaterials and drug-based drug delivery applications, exhaustively covers the nanotechnological aspects, concepts, properties, characterisation, application, biofate and regulatory aspects of dendrimers. It includes sixteen vivid chapters by renowned formulators, researchers and academicians from all over the world, highlighting their specialised areas of interest in the fields of chemistry, biology, pharmacy and nanomedicine.

Features:

• Highlights dendrimers’ advancements in nanomedicine in the development of safe healthcare and biotechnological products

• Covers physicochemical aspects, biofate, drug delivery aspects and gene therapy using dendrimers

• Covers biomedical application of dendrimers in the field of biological sciences

• Gives examples of dendrimer–guest interaction chemistry

Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives provides the comprehensive overview of the latest research efforts in designing, optimising, development and scale-up of dendrimer-mediated delivery systems. It analyses the key challenges of synthesis, design, molecular modelling, fundamental concepts, drug delivery aspects, analytical tools and biological fate as well as regulatory consideration to the practical use of dendrimer application.

Dr. Neelesh Kumar Mehra Assistant Professor of Pharmaceutics in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He has authored more than sixty peer-reviewed publications in highly reputed international journals, as well as book chapters and contributions on two patents. Dr. Mehra has 11 years of rich research and teaching experience in the formulation and development of complex, innovative biopharmaceutical products including micro- and nanotechnologies for regulated markets.

Dr. Keerti Jain Assistant Professor of Pharmaceutics in the Department of Pharmaceutics, NIPER, Raebareli, India. For more than 10 years, she has been actively engaged in formulation and development of nanomedicines. Dr. Jain has supervised masters and doctoral pharmaceutics students in their research works which have been published in high quality, good impact factor journals. She has also authored more than 60 international manuscripts in peer reviewed high impact journals. In 2019, she was awarded the prestigious ICMR-Amir Shakuntala Award.

This book provides comprehensive information of the nanotechnology-based pharmaceutical product development including a diverse range of arenas such as liposomes, nanoparticles, fullerenes, hydrogels, thermally responsive externally activated theranostics (TREAT), hydrogels, microspheres, micro- and nanoemulsions and carbon nanomaterials. It covers the micro- and nanotechnological aspects for pharmaceutical product development with the product development point of view and also covers the industrial aspects, novel technologies, stability studies, validation, safety and toxicity profiles, regulatory perspectives, scale-up technologies and fundamental concept in the development of products.

Salient Features:

Dr. Neelesh Kumar Mehra is working as an Assistant Professor of Pharmaceutics & Biopharmaceutics at the Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He received ‘TEAM AWARD’ for successful commercialisation of an ophthalmic suspension product. He has authored more than 60 peer-reviewed publications in highly reputed international journals and more than 10 book chapter contributions. He has filed patents on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He guided PhD and MS students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist Award and Team Award for his research output. He recently published one edited book, ‘Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives’, in CRC Press. Currently, he is editing books on nano drug delivery-based products with Elsevier Pvt Ltd. He has rich research and teaching experience in the formulation and development of complex, innovative ophthalmic and injectable biopharmaceutical products including micro- and nanotechnologies for regulated market.

Dr. Arvind Gulbake is working as an Assistant Professor at the Faculty of Pharmacy, School of Pharmaceutical & Population Health Informatics, at DIT University, Dehradun, India. He has authored more than 40 peer-reviewed publications in highly reputed international journals, four book chapters and a patent contribution. He has received outstanding awards including Young Scientist Award and BRG Travel Award for his research. He is an assistant editor for IJAP. He guided PhD and MS students for their dissertations/research projects. He has successfully completed extramural project funded by SERB, New Delhi, Government of India. He has more than 12 years of research and teaching experience in the formulation and development of nanopharmaceuticals.

This book provides comprehensive information of the nanotechnology-based pharmaceutical product development including a diverse range of arenas such as liposomes, nanoparticles, fullerenes, hydrogels, thermally responsive externally activated theranostics (TREAT), hydrogels, microspheres, micro- and nanoemulsions and carbon nanomaterials. It covers the micro- and nanotechnological aspects for pharmaceutical product development with the product development point of view and also covers the industrial aspects, novel technologies, stability studies, validation, safety and toxicity profiles, regulatory perspectives, scale-up technologies and fundamental concept in the development of products.

Salient Features:

Dr. Neelesh Kumar Mehra is working as an Assistant Professor of Pharmaceutics & Biopharmaceutics at the Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He received ‘TEAM AWARD’ for successful commercialisation of an ophthalmic suspension product. He has authored more than 60 peer-reviewed publications in highly reputed international journals and more than 10 book chapter contributions. He has filed patents on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He guided PhD and MS students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist Award and Team Award for his research output. He recently published one edited book, ‘Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives’, in CRC Press. Currently, he is editing books on nano drug delivery-based products with Elsevier Pvt Ltd. He has rich research and teaching experience in the formulation and development of complex, innovative ophthalmic and injectable biopharmaceutical products including micro- and nanotechnologies for regulated market.

Dr. Arvind Gulbake is working as an Assistant Professor at the Faculty of Pharmacy, School of Pharmaceutical & Population Health Informatics, at DIT University, Dehradun, India. He has authored more than 40 peer-reviewed publications in highly reputed international journals, four book chapters and a patent contribution. He has received outstanding awards including Young Scientist Award and BRG Travel Award for his research. He is an assistant editor for IJAP. He guided PhD and MS students for their dissertations/research projects. He has successfully completed extramural project funded by SERB, New Delhi, Government of India. He has more than 12 years of research and teaching experience in the formulation and development of nanopharmaceuticals.

Carbon nanotubes (CNTs) have emerged as novel carbon-based nanomaterials with unique physicochemical properties for pharmaceutical and biomedical applications. This book provides the fundamental concept, basic physicochemical properties, functionalization, method of synthesis, applications, and regulatory considerations of CNTs. The primary objective of the editors and authors is to exhaustively cover the fundamentals of carbon nanomaterials, carbon nanotubes, functionalization and chemistries involved, drug delivery aspects, and applications along with their regulatory aspects.

Carbon nanotubes (CNTs) have emerged as novel carbon-based nanomaterials with unique physicochemical properties for pharmaceutical and biomedical applications. This book provides the fundamental concept, basic physicochemical properties, functionalization, method of synthesis, applications, and regulatory considerations of CNTs. The primary objective of the editors and authors is to exhaustively cover the fundamentals of carbon nanomaterials, carbon nanotubes, functionalization and chemistries involved, drug delivery aspects, and applications along with their regulatory aspects.

The aim of the proposed book is to provide exhaustive information about the fundamental concepts, theory and applications of the simple and complex ophthalmic dosage forms with emphasis on the regulatory aspects of the same for formulators and academic / industrial researchers. The proposed book comprehensively covers the current research trends and industrial inputs beginning from the pharmaceutical product development strategy, composition, labelling, challenges, NDA vs ANDA filing to the advanced drug delivery approaches using novel micro and nanocarriers, fixed–dose combinations, role of preservatives in product development and so on. This book also covers various eye related disease like glaucoma, age-related macular degeneration, uveal melanoma, cataract, fungal keratitis, conjunctivitis, blindness etc. which need to be treatable.

The sterile ophthalmic product development approaches inclusive of different drug delivery dosage form technologies have been revolutionary in current healthcare, pharmaceutical research and innovation. However, it has its own challenges in scale up and commercial aspects, which could be a reason for limited scope and availability of ophthalmic products in market. Development of complex sterile ophthalmic product is crucial and needs proper systematic approaches starting from pre-formulation till validation, scale up and commercialization including toxicological data. This book presents these approaches in vivid chapters contributed by renowned formulators, researchers and academician working in the fields of ophthalmic product development across the world.

The primary audience for the proposed book would be academic and industrial researchers, PhD/postdoctoral research fellows, formulation scientists and bio-medical professionals. The comprehensive focus on fundamental concepts, advanced drug formulation and regulatory guidelines will benefit students as well as professionals in the field of ophthalmic medicine.

This book, Complex Ophthalmic Dosage Forms: Advances in Biomedical Applications and Future Perspectives, offers a detailed overview of the latest innovations in ophthalmic drug delivery. Beginning with the fundamentals of ocular drug delivery systems and the anatomy of the eye, this book provides an exploration of drug delivery to both the anterior and posterior segments. A dedicated chapter on the fixed-dose combination approach examines its application in ocular diseases, highlighting both its therapeutic potential and associated challenges. Furthermore, the book delves into key aspects of ophthalmic product development, including reverse engineering, the role of preservatives, and the application of Quality by Design (QbD) principles. It includes discussions on the safety of nanoformulations, as well as an in-depth analysis of emerging nano-assisted platforms in ocular drug delivery, highlighting both opportunities and safety concerns. Recognizing the importance of packaging a dedicated chapter explores the critical role of sterility in ocular products, detailing sterility validation processes to ensure product safety and efficacy. This is followed by a thorough discussion on packaging, including the selection of appropriate containers and closure systems. Given that an optimized packaging system is essential for maintaining the stability, sterility, and overall quality of ophthalmic products, this section highlights key considerations in designing effective packaging solutions. Additionally, the book delves into regulatory considerations, challenges in clinical translation, and potential future developments that may redefine ophthalmic therapeutics.