Table Of ContentMicro- and Nanotechnologies-Based
Product Development
Micro- and Nanotechnologies-Based
Product Development
Edited by
Neelesh Kumar Mehra and Arvind Gulbake
First edition published 2022
by CRC Press
6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742
and by CRC Press
2 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
© 2022 Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, LLC
Reasonable eforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the
validity of all materials or the consequences of their use. Te authors and publishers have attempted to trace the copyright holders of all material
reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright
material has not been acknowledged please write and let us know so we may rectify in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any
electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microflming, and recording, or in any
information storage or retrieval system, without written permission from the publishers.
For permission to photocopy or use material electronically from this work, access www.copyright.com or contact the Copyright Clearance
Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. For works that are not available on CCC please contact
[email protected]
Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identifcation and explanation
without intent to infringe.
Library of Congress Cataloging-in-Publication Data
Names: Mehra, Neelesh Kumar, editor. | Gulbake, Arvind, editor.
Title: Micro and nanotechnologies based product development / edited by Neelesh Kumar Mehra and Arvind Gulbake.
Description: First edition. | Boca Raton : CRC Press, 2022. | Includes bibliographical references and index.
Identifers: LCCN 2021011182 | ISBN 9780367488451 (hardback) | ISBN 9781032050720 (paperback) | ISBN 9781003043164 (ebook)
Subjects: MESH: Nanostructures | Drug Delivery Systems | Drug Development | Nanotechnology | Microtechnology
Classifcation: LCC RM301.25 | NLM QT 36.5 | DDC 615.1/9—dc23
LC record available at https://lccn.loc.gov/2021011182
ISBN: 9780367488451 (hbk)
ISBN: 9781032050720 (pbk)
ISBN: 9781003043164 (ebk)
DOI: 10.1201/9781003043164
Typeset in Times
by codeMantra
Contents
Preface..................................................................................................................................................................................vii
Editors ...................................................................................................................................................................................ix
List of Contributors ...............................................................................................................................................................xi
SECTION A Introduction
Chapter 1 Micro- and Nanotechnology Approaches: Concepts and Applications ...........................................................3
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 .........................15
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 ........................................................................................................ 33
Renuka Khatik, Aakanchha Jain, and Faheem Hyder Pottoo
Chapter 4 C -Fullerenes as an Emerging Cargo Carrier for the Delivery of Anti-Neoplastic Agents:
60
Promises and Challenges ...............................................................................................................................49
Nagarani Thotakura and Kaisar Raza
SECTION B Bioactive Delivery Systems
Chapter 5 Pharmaceutical and Biomedical Applications of Multifunctional Quantum Dots ........................................65
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 ....................................................................83
Akash Chaurasiya, Parameswar Patra, Pranathi Thathireddy, and Amruta Gorajiya
Chapter 7 Targeted Lipid-Based Nanoparticles for Nucleic Acid Delivery in Cancer Therapy .....................................95
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 ..................................... 115
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 ......................................... 139
Sushama Talegaonkar, Debopriya Dutta, Namita Chaudhary, Surya Goel, and Ruchi Singh
Chapter 10 Resealed Erythrocytes: A Biological Carrier for Drug Delivery ................................................................. 163
Satish Shilpi, Kapil Khatri, Umesh Dhakad, Neelesh Kumar Mehra, and Arvind Gulbake
v
vi Contents
Chapter 11 Nanostructured Hydrogel-Based Biosensor Platform ..................................................................................177
Anand Singh Patel and Keerti Jain
Chapter 12 Multifunctional Carbon Nanotubes in Drug Delivery .................................................................................187
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 ................................................................................209
Radha Rani, Neha Raina, Azmi Khan, Manupriya Choudhary, and Madhu Gupta
Chapter 14 Impact and Role of Stability Studies in Parenteral Product Development ..................................................225
Mohammed Asadullah Jahangir, Syed Sarim Imam, and Jayamanti Pandit
Chapter 15 Reverse Engineering in Pharmaceutical Product Development ...................................................................235
Rishi Paliwal, Aanjaneya Mamgain, Rameshroo Kenwat, and Shivani Rai Paliwal
Chapter 16 Role of Polymers in Formulation Design and Drug Delivery ......................................................................243
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 ......................................................................................................257
Iara Baldim, Adriana M. Ribeiro, João Dias-Ferreira, Wanderley P. Oliveira,
Francisco M. Gama, and Eliana B. Souto
Chapter 18 Validation, Scale-Up and Technology Transfer in Product Development....................................................269
Ankit Gaur, Anamika Sahu Gulbake, Neelesh Kumar Mehra, and Arvind Gulbake
Chapter 19 Nanotoxicology: Safety, Toxicity and Regulatory Considerations ...............................................................285
Raja Susmitha, Mounika Gayathri Tirumala, Mohd Aslam Saifi, and Chandraiah Godugu
Index ..................................................................................................................................................................................305
Preface
In the current scenario, micro- and nanotechnology-based of products. Chapter 3 reviews the thermally responsive
product development is a boon in the healthcare, pharma- externally activated theranostics as multifunctional drug
ceutical, research and innovation area. Product develop- delivery systems. Chapter 4 summarises the drug delivery
ment is a rapidly growing and emerging area consisting aspects, promises and challenges of fullerenes for the deliv-
of multifunctional micro- and nano-size engineered nano- ery of anti-neoplastic agents. Chapter 5 discusses the phar-
materials (ENM) useful for the delivery of biotherapeutics maceutical and biomedical applications of multifunctional
(large and small molecules). quantum dots to the healthcare sector. Chapter 6 discusses
As of now, very few micro- and nanotechnology-based and summarises the PLGA-based micro- and nanoparticles
products are available on the market. The development and challenges, technical aspects and commercial platform
of complex sterile and non-sterile products is crucial updated from research laboratory to market. Chapter 7
and needs proper systemic approaches starting from pre- reviews the targeted stable nucleic acid-based lipid
formulation to validation and scale-up including toxicol- nanoparticles in cancer therapy. Chapter 8 summarises the
ogy data. formulation strategies for the delivery of hydrophilic drugs
The aim of this book is to provide exhaustive information for ophthalmic diseases. Chapter 9 reviews and elaborates
to the formulators and researchers in product development on metal nanoparticles in drug delivery and diagnostics.
with emphasis on academic and industry perspectives along Chapter 10 elaborates on the resealed erythrocytes and
with regulatory perspectives. This book exhaustively covers their promising applications in drug delivery. Chapter 11
the current research input beginning from the product strat- reviews the nanostructured hydrogel-based biosensor plat-
egy, scale-up by applying the recent technologies including form for promising biomedical applications. Chapter 12
quality by design, process optimisation, validation, reverse discusses carbon nanotubes, physicochemical proper-
engineering, process analytical technology, stability and ties and drug delivery aspects for biomedical and pharm-
regulatory toxicology including the pharmacokinetics and aceutical applications. Chapter 13 exhaustively covers the
pharmacodynamics of product development. It is edited stability studies as per the regulatory guideline require-
through contribution of vivid chapters from renowned for- ments for parenteral product development. Chapter 14
mulators, researchers and academicians across the world discusses the current landscape, limitations and technolo-
with their specialised research area of interest. gies for industrial scale-up for liposome-based pharmaceu-
Our primary target readers are postgraduates, and post- tical formulations. Chapter 15 covers reverse engineering
doctoral research fellows with formulators, researchers and and its principle and role in generic product development.
academicians to extend their knowledge through this book Chapter 16 covers the various polymers used in the design
and also those who are working in drug delivery area. The of formulation for drug delivery development. Chapter 17
book contains (i) the fundamental concepts, theory and discusses the quantitative pharmacology and different sta-
advancement of micro- and nanotechnologies; (ii) bioma- tistical methods for drug safety in the ocular route for sterile
terials and their applications; (iii) recent trends/ innovations ocular product development. Chapter 18 covers validation,
and developments; (iv) sterile product development, tech- scale-up and technology transfer in the development of
nology transfer and validation; and (v) toxicological pharmaceutical products. Chapter 19 covers the various
perspectives. safety, toxicity and regulatory considerations.
Chapter 1 is about the use of micro- and nanotechnolo-
gies in product development of large and small molecules. Editors
Chapter 2 exhaustively comprises the formulation-by- Neelesh Kumar Mehra, PhD
design approaches, which are required in the development Arvind Gulbake, PhD
vii
Editors
Dr. Neelesh Kumar Mehra formulation and development of complex, innovative oph-
is working as an Assistant thalmic and injectable biopharmaceutical products includ-
Professor of Pharmaceu- ing micro- and nanotechnologies for regulated market.
tics & Biopharmaceutics
at the Department of Dr. Arvind Gulbake is work-
Pharmaceutics, National ing as an Assistant Professor at
Institute of Pharmaceutical the Faculty of Pharmacy, School
Education & Research of Pharmaceutical & Population
(NIPER), Hyderabad, India. Health Informatics, at DIT
He earned his PhD from Dr. University, Dehradun. Earlier,
Harisingh Gour University, he worked as a Coordinator,
Sagar, and postdoc from Research & Development,
Irma Lerma Rangel Centre for Interdisciplinary
College of Pharmacy, Texas A&M Health Science Center, Research, D.Y. Patil Education
Kingsville, TX, USA. He served as Manager in Product Society (Institution Deemed to
Development, Sentiss Research Centre, Sentiss Pharma Pvt be University), Kolhapur, Maharashtra, India. He earned
Ltd, Gurgaon, for development, scale-up and technology his PhD with Prof. Sanjay K. Jain from Dr. Harisingh
transfer of complex ophthalmic, inhalation and optic phar- Gour University, Sagar. He has authored more than 40
maceutical products. He received ‘TEAM AWARD’ for peer-reviewed publications in highly reputed international
successful commercialisation of an ophthalmic suspension journals, four book chapters and a patent contribution.
product. He has authored more than 60 peer-reviewed pub- He guided PhD and MS students for their dissertations/
lications in highly reputed international journals and more research projects. He successfully completed an extra-
than 10 book chapter contributions. He has filed a patent on mural project funded by SERB, New Delhi, Government
Pharmaceutical composition and manufacturing process of of India. He has received outstanding awards including
novel nanoformulations to improved therapeutic efficacy for Young Scientist Award and BRG Travel Award for his
topical delivery. He guided PhD and MS students for their research. He is a peer reviewer of various international
dissertations/research projects. He has received numerous journals and publications. He is an assistant editor for
outstanding awards including Young Scientist Award and the International Journal of Applied Pharmaceutics and
Team Award for his research output. He is a peer reviewer of an editorial board member of the Journal of Liposome
various international journals and publications. He recently Research. He is a member of various academic commit-
published one edited book, ‘Dendrimers in Nanomedicine: tees at the university level, i.e. Board of Studies (Masters
Concept, Theory and Regulatory Perspectives’, in CRC and PhD), IBSC, IAEC, IQAC and Institutional Research
Press. Currently, he is editing books on biopharmaceuti- Committee. He has more than 12 years of research and
cal and nanotechnology-based products with Elsevier Pvt teaching experience in the formulation and development
Ltd. He has rich research and teaching experience in the of nanopharmaceuticals.
ix
