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1st Edition

Micro- and Nanotechnologies-Based Product Development




ISBN 9781003043164
Published September 6, 2021 by CRC Press
326 Pages 50 Color & 13 B/W Illustrations

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Book Description

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:

  1. Covers micro- and nanotechnology approaches with current trends with safety and efficacy in product development.
  2. Presents an overview of the recent progress of stability testing, reverse engineering, validation and regulatory perspectives as per regulatory requirements.
  3. Provides a comprehensive overview of the latest research related to micro- and nanotechnologies including designing, optimisation, validation and scale-up of micro- and nanotechnologies.
  4. Is edited by two well-known researchers by contribution of vivid chapters from renowned scientists across the globe in the field of pharmaceutical sciences.

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.

Table of Contents

Section A Introduction

Chapter 1 Micro- and Nanotechnology Approaches: Concepts and Applications

[Bhavana Valamla, Pradip Thakor, Neelesh Kumar Mehra, Arvind Gulbake, and Satish Shilpi]

Chapter 2 Formulation by Design (FbD): An Emerging Approach to Design Vesicular Nanocarriers

[Shiv Kumar Prajapati, Payal Kesharwani, Nishi Mody, Ankit Jain, and Swapnil Sharma]

Chapter 3 Thermally Responsive Externally Activated Theranostics (TREAT) for On-Demand

Multifunctional Drug Delivery Systems

[Renuka Khatik, Aakanchha Jain, and Faheem Hyder Pottoo]

Chapter 4 C60-Fullerenes as an Emerging Cargo Carrier for the Delivery of Anti-Neoplastic Agents:

Promises and Challenges

[Nagarani Thotakura and Kaisar Raza]

Section B Bioactive Delivery Systems

Chapter 5 Pharmaceutical and Biomedical Applications of Multifunctional Quantum Dots

[Devesh Kapoor, Swapnil Sharma, Kanika Verma, Akansha Bisth, Yashu Chourasiya,

Mayank Sharma, and Rahul Maheshwari]

Chapter 6 PLGA-Based Micro- and Nano-particles: From Lab to Market

[Akash Chaurasiya, Parameswar Patra, Pranathi Thathireddy, and Amruta Gorajiya]

Chapter 7 Targeted Lipid-Based Nanoparticles for Nucleic Acid Delivery in Cancer Therapy

[Prashant Upadhaya, Swapnil Talkar, Vinod Ghodake, Namrata Kadwadkar, Anjali Pandya,

Sreeranjini Pulakkat, and Vandana B. Patravale]

Chapter 8 Formulation Strategies for Improved Ophthalmic Delivery of Hydrophilic Drugs

[Arehalli Manjappa, Popat Kumbhar, John Disouza, Suraj Pattekari, and Vandana B. Patravale]

Chapter 9 Metal Nanoparticles as a Surrogate Carrier in Drug Delivery and Diagnostics

[Sushama Talegaonkar, Debopriya Dutta, Namita Chaudhary, Surya Goel, and Ruchi Singh]

Chapter 10 Resealed Erythrocytes: A Biological Carrier for Drug Delivery

[Satish Shilpi, Kapil Khatri, Umesh Dhakad, Neelesh Kumar Mehra, and Arvind Gulbake]

Chapter 11 Nanostructured Hydrogel-Based Biosensor Platform

[Anand Singh Patel and Keerti Jain]

Chapter 12 Multifunctional Carbon Nanotubes in Drug Delivery

[Anamika Sahu Gulbake, Ankit Gaur, Aviral Jain, Satish Shilpi, Neelesh Kumar Mehra,

and Arvind Gulbake]

Section C Product Development, Toxicity and Scale-Up

Chapter 13 Liposomal-Based Pharmaceutical Formulations ・ Current Landscape,

Limitations and Technologies for Industrial Scale-Up

[Radha Rani, Neha Raina, Azmi Khan, Manupriya Choudhary, and Madhu Gupta]

Chapter 14 Impact and Role of Stability Studies in Parenteral Product Development

[Mohammed Asadullah Jahangir, Syed Sarim Imam, and Jayamanti Pandit]

Chapter 15 Reverse Engineering in Pharmaceutical Product Development

[Rishi Paliwal, Aanjaneya Mamgain, Rameshroo Kenwat, and Shivani Rai Paliwal]

Chapter 16 Role of Polymers in Formulation Design and Drug Delivery

[Satish Shilpi, Umesh Dhakad, Rajkumari Lodhi, Sonal Dixit, Kapil Khatri,

Neelesh Kumar Mehra, and Arvind Gulbake]

Chapter 17 Drug Delivery Systems for Targeting Blood Brain Barrier: Examples of nanomedicines for the treatment of neurodegenerative diseases

[Iara Baldim, Adriana M. Ribeiro, Joao Dias-Ferreira, Wanderley P. Oliveira,

Francisco M. Gama, and Eliana B. Souto]

Chapter 18 Validation, Scale-Up and Technology Transfer in Product Development

[Ankit Gaur, Anamika Sahu Gulbake, Neelesh Kumar Mehra, and Arvind Gulbake]

Chapter 19 Nanotoxicology: Safety, Toxicity and Regulatory Considerations

[Raja Susmitha, Mounika Gayathri Tirumala, Mohd Aslam Saifi, and Chandraiah Godugu]

...
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Editor(s)

Biography

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 earned his PhD from Dr. H.S. Gour University, Sagar and PostDoc from Irma Lerma Rangel College of Pharmacy, Texas A & M Health Science Centre, Kingsville, TX, USA. He served as Manager in Product Development, Sentiss Research Centre, Sentiss Pharma Pvt Ltd. Gurgaon for development, scale-up and technology transfer of complex ophthalmic, inhalation and optic pharmaceutical products. He received ‘TEAM AWARD’ for successful commercialisation of Ophthalmic Suspension product. He has authored more than 60 peer-reviewed publications in high repute International Journals, and >10 book chapter contributions. He has filed patent on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He guided PhD and M.S. students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist and Team Awards for their research output. He is a peer reviewer of various international Journals and publishers. He recently published one edited book "Dendrimers in Nanomedicine Concept, Theory and Regulatory Perspectives" in CRC Press. Currently, he is editing books on Biopharmaceutical and nanotechnology based 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 and so on.

Dr. Arvind Gulbake is working as an Assistant Professor, Department of Pharmaceutics, School of Pharmaceutical & Population Health Informatics at DIT University, Dehradun. Earlier, he was worked as a Coordinator, Research & Development, Centre for Interdisciplinary Research, D.Y. Patil Education Society, Institutions Deemed to be University, Kolhapur, Maharashtra, India. He earned his PhD with Prof. Sanjay K. Jain from Dr. Harisingh Gour University, Sagar. He has authored more than 40 peer-reviewed publications in high repute International Journals, 4 book chapters and a patent contribution. He guided PhD and M.S. students for their dissertations/research projects. He successfully completed extramural project funded by SERB, New Delhi, Government of India. He has received outstanding awards including Young Scientist and BRG Travel Award for his research. He is a peer reviewer of various International Journals and publishers. He is an assistant editor for International Journal of Applied Pharmaceutics and editorial board member in Journal of Liposome Research. He is a member of various academic committees at University level i.e., Board of Studies (Masters and Ph.D.), IBSC, IAEC, IQAC and Institutional Research Committee. He has more than 12 years of research and teaching experience in the formulation and development of nanopharmaceuticals