in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.
Library of Congress Cataloging‐in‐Publication Data
Names: Shunmugaperumal, Tamilvanan, author.
Title: Oil‐in‐water nanosized emulsions for drug delivery and targeting / Tamilvanan Shunmugaperumal.
Description: First edition. | Hoboken : Wiley, [2021] | Includes bibliographical references and index.
Identifiers: LCCN 2021019779 (print) | LCCN 2021019780 (ebook) | ISBN 9781119585220 (hardback) | ISBN 9781119585329 (adobe pdf) | ISBN 9781119585251 (epub)
Subjects: LCSH: Drug delivery systems. | Emulsions. | Oils and fats–Solubility. | Nanomedicine.
Classification: LCC RS199.5 .S58 2021 (print) | LCC RS199.5 (ebook) | DDC 615.1/9–dc23
LC record available at https://lccn.loc.gov/2021019779 LC ebook record available at https://lccn.loc.gov/202101978
Cover Design: Wiley
Cover Image: Courtesy of Tamilvanan Shunmugaperumal
I dedicate this book to my wife, Suriaprabha Marchen for her support, my son, Arunachalam Tamilvanan for his play‐time sacrifice with me, my director, Dr. USN Murty for his encouragement and sustained help, and all coauthors for their enthusiasm toward achieving the vision of this book.
I dedicate this book to my father (late) Shunmugaperumal and mother Pethammal. I also dedicate this book to Prof. Simon Benita, School of Pharmacy, Hebrew University of Jerusalem, Israel.
LIST OF CONTRIBUTORS
Abhinab Goswami, Research scholar, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India
Oly Katari, Research scholar, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India
Datta Maroti Pawde, Research scholar, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India
Syed Nazrin Ruhina Rahman, Research scholar, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India
Tamilvanan Shunmugaperumal, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India
FOREWORD
It gives me an immense pleasure to write foreword for a book written by my colleague. This book provides comprehensive information concerning the oil‐in‐water nanosized emulsions as drug delivery carrier and drug targeting purpose. Very importantly, the generations of nanosized emulsions are updated according to the present‐day research focus, especially for reachable and unreachable organs/parts of the human body and thus, permitting the target place‐precised drug delivery and/or improved drug bioabsorption. A dedicated section covered in this book under heading, “Biofate of Nanosized Emulsions,” after their administration via different routes (dermal, nasal, ocular and parenteral) is a subject matter of interest for researchers. I strongly feel that this book will serve as a guide for formulation scientists working on oil‐in‐water nanosized emulsions in academic and industry levels.
DR. USN MURTY
Director
National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India
PREFACE
Over the years, so many new chemical entities (NCE) are constantly being discovered/designed/synthesized and even sometimes few NCE claim to be “molecular breakthrough” showing additional/exceptional better therapeutic activities in managing/treating single or multiple ailments. The so‐called molecular breakthrough NCE, in most of the times, are unable to provide the intended therapeutic application as they were thought initially. Thus, a question has come to find out the answer “why the sudden lacuna that prevents the successful development of NCE from laboratory to market (L‐to‐M).” In the present scenario, the L‐to‐M consists of multiple stages that include laboratory‐scale preformulation studies, systematic optimization of a formula to incorporate the NCE into the selected formulation, NCE‐incorporated formulation characterization and safety assessment at non/preclinical levels, clinical trials using the optimized NCE‐laden formulation including the toxicity assessment at multicentric levels, patenting and regulatory approval processes, market assessment, targeting and positioning of final product, etc. Although each stages of product development require considerable/significant attention and care, the preformulation and formulation development stages become a cutting‐edge decision‐making stage where the formulation development scientist will decide whether to allow the NCE‐laden formulation to proceed for further stages or to send back the NCE to the previous NCE design/discovery/synthesis stage. Furthermore, the cutting‐edge decision‐making stage is very important in industrial point‐of‐view to avoid any further utilization of manpower, money, and time on a particular molecular breakthrough NCE.
Ranging from 40 to 70%, the molecular breakthrough NCE possess exceptionally water‐insoluble characteristics and therefore compelling the formulation developers to look into or to go for any suitable formulation that may fit for the selected NCE rather than simply trying to make aqueous/nonaqueous‐based solution‐type formulation. One of the amazing drug delivery carrier systems that suit for such NCE is oil‐in‐water (o/w)‐type nanosized emulsions. The o/w nanosized emulsions possess the success stories for taking the active pharmaceutical ingredients (APIs) into desirable target organs of human body, particularly in terms of non‐parenteral (especially ocular) and parenteral routes. The in‐or‐new‐born internal structures observed in the dispersed oil droplets of o/w nanosized emulsions are the welcome additions in emulsion technology wherein two or three API molecules can easily be accommodated simultaneously during the emulsification time itself. Such recent observations of in‐or‐new‐born internal structures in the o/w nanosized emulsions include “Cerberus and Janus” and corresponding names given to the emulsions are Cerberus emulsions and Janus emulsions. These types of new emulsions, although at their rudimentary stage of development, are capable of escalating the o/w nanosized emulsion's utility in multiple directions viz., drug solubility enhancers, dual/triple drug‐loading vehicle, imaging and theragnostic purposes, etc.
This book provides very comprehensively the details of o/w nanosized emulsions at the grass‐root level so that the formulation scientist can understand how to select the proper excipients such as emulsifier combination,