Oil-in-Water Nanosized Emulsions for Drug Delivery and Targeting E-Book
Tamilvanan Shunmugaperumal
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- Herausgeber: John Wiley & Sons
- Kategorie: Wissenschaft und neue Technologien
- Sprache: Englisch
This book combines emulsion knowledge into a single, comprehensive volume, ideal for professionals and students involved in the areas of pharmaceutical science who are looking to learn about this emergent research concept. * Compiles the step-by-step investigations made concerning the potential of nanosized emulsions on both drug delivery and drug targeting areas by different group of scientists in various laboratories across the world * Inverts the common nano-emulsions coverage trend of focusing on focused on the particulate system itself, instead exploring the way to turn nanosized emulsions as biomedical tool, as well as, treating the in vitro and in vivo aspects after administration * Provides an overview of the current state-of-the art regarding the development of tocol emulsions, emulsion adjuvants in immunization research, oxygen-carrying emulsions (called as fluorocarbon emulsion) and emulsions for delivering drugs to nasal and topical (ocular and transdermal) routes
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Table of Contents
COVER
TITLE PAGE
COPYRIGHT PAGE
LIST OF CONTRIBUTORS
FOREWORD
PREFACE
CHAPTER 1: INTRODUCTION: AN OVERVIEW OF NANOSIZED EMULSIONS
1.1. INTRODUCTION
1.2. CONCLUSION
REFERENCES
CHAPTER 2: FORMULATION DEVELOPMENT OF OIL‐IN‐WATER NANOSIZED EMULSIONS
2.1. INTRODUCTION
2.2. FDA‐APPROVED OILS, EMULSIFIERS, AND AUXILIARY OR MISCELLANEOUS EXCIPIENTS
2.3. CURRENT AND NEAR FUTURE DIRECTION
2.4. LIPOPHILIC API INCORPORATION PATTERN INTO NANOSIZED EMULSIONS
2.5. QbD APPROACH TO OPTIMIZE EMULSION
2.6. CONCLUSION
REFERENCES
CHAPTER 3: CHARACTERIZATION AND SAFETY ASSESSMENT OF OIL‐IN‐WATER NANOSIZED EMULSIONS
3.1. INTRODUCTION
3.2. PHYSICAL AND VISUAL EVALUATIONS
3.3. CHEMICAL AND BIOLOGICAL EVALUATIONS
3.4. SAFETY AND EFFICACY ASSESSMENTS
3.5. CONCLUSION
REFERENCES
CHAPTER 4: MANUFACTURING AND POSITIONING (GENERATIONS) OF OIL‐IN‐WATER NANOSIZED EMULSIONS
4.1. INTRODUCTION
4.2. GENERATIONS OF O/W NANOSIZED EMULSIONS
4.3. PREPARATION METHODS FOR API‐FREE/LOADED O/W NANOSIZED EMULSIONS
4.4. CONCLUSION
REFERENCES
CHAPTER 5: BIOFATE OF NANOSIZED EMULSIONS
5.1. INTRODUCTION
5.2. BIOFATE OF O/W NANOSIZED EMULSIONS
5.3. CLINICAL ISSUES OF FIRST‐GENERATION NANOSIZED EMULSIONS
5.4. CONCLUSION
REFERENCES
CHAPTER 6: MEDICAL OR THERAPEUTICAL APPLICATIONS OF OIL‐IN‐WATER NANOSIZED EMULSIONS
6.1. INTRODUCTION
6.2. MEDICAL OR THERAPEUTICAL APPLICATIONS OF O/W NANOSIZED EMULSIONS
6.3. CONCLUSION
REFERENCES
PART I: OVERVIEW OF TOCOL‐BASED EMULSIONS, OXYGEN‐CARRYING EMULSIONS, EMULSIONS WITH DOUBLE OR TRIPLE CARGOS AND EMULSION‐LIKE DISPERSIONS
CHAPTER 7: OVERVIEW OF TOCOL‐BASED EMULSIONS, OXYGEN‐CARRYING EMULSIONS, EMULSIONS WITH DOUBLE OR TRIPLE CARGOS AND EMULSION‐LIKE DISPERSIONS
CHAPTER 7.1: TOCOL‐BASED NANOSIZED EMULSIONS
7.1.1. INTRODUCTION
7.1.2. FORMULATION DEVELOPMENT USING TOCOL
7.1.3. NON‐ AND PRE‐CLINICAL SAFETY STUDIES
7.1.4. THERAPEUTIC APPLICATIONS
7.1.5. CONCLUSION
REFERENCES
CHAPTER 7.2: OXYGEN‐CARRYING EMULSIONS
7.2.1. INTRODUCTION
7.2.2. RATIONALE FOR SELECTING PERFLUOROCARBON FOR
IN VIVO
OXYGEN TRANSPORT
7.2.3. FORMULATION OF STABLE INJECTABLE PERFLUOROCARBON EMULSIONS
7.2.4. MULTIFUNCTIONAL PERFLUOROCARBON‐BASED EMULSIONS
7.2.5. GENERATIONS AND HURDLES OF PERFLUOROCARBON‐BASED NANOSIZED EMULSIONS AS OXYGEN CARRIERS
7.2.6. PROPOSED SOLUTIONS TO OVERCOME THE HURDLES OF PERFLUOROCARBON‐BASED NANOSIZED EMULSIONS USED AS OXYGEN CARRIERS
7.2.7. CONCLUSION
REFERENCES
CHAPTER 7.3: NANOSIZED EMULSIONS FOR MULTIPLE MEDICAMENT LOADINGS, IMAGING, AND THERANOSTIC PURPOSES
7.3.1. INTRODUCTION
7.3.2. BRIEF REVIEW OF RESEARCH REPORTS ON NANOSIZED EMULSIONS FOR IMAGING AND THERANOSTIC PURPOSE
7.3.3. VARIOUS TOPOLOGIES OBSERVED IN DISPERSED OIL DROPLETS OF THE EMULSIONS
7.3.4. POSSIBLE THERAPEUTIC UTILITY OF JANUS EMULSION
7.3.5. CONCLUSION
REFERENCES
CHAPTER 7.4: EMULSION‐LIKE DISPERSIONS
7.4.1. INTRODUCTION
7.4.2. FORMULATION OF EMULSION‐LIKE DISPERSIONS
7.4.3. CONCLUSION
REFERENCES
PART II: SELECTED CASE STUDIES
CHAPTER 8: SELECTED CASE STUDIES
CHAPTER 8.1: CASE STUDY 1: CATIONIC NANOSIZED EMULSIONS: NARRATION OF COMMERCIAL SUCCESS
8.1.1. INTRODUCTION
8.1.2. SELECTION OF SUITABLE CATION‐CONFERRING AGENT
8.1.3. SELECTION OF SUITABLE PRESERVATIVE IF NEEDED
8.1.4. CLINICAL SAFETY ASSESSMENT
8.1.5. CONCLUSION
REFERENCES
CHAPTER 8.2: CASE STUDY 2: FISH OIL‐BASED NANOSIZED EMULSIONS
8.2.1. INTRODUCTION
8.2.2. IMPORTANCE OF FISH OIL OR FISH OIL SUPPLEMENTS IN EVERYDAY HUMAN LIFE
8.2.3. OVERVIEW ON ENVIRONMENT‐FRIENDLY GREEN‐EXTRACTION METHODS OF FISH OIL FROM WHOLE FISH OR FISHERIES WASTE
8.2.4. RATIONALE FOR DEVELOPING NANOSIZED EMULSIONS BASED ON FISH OIL
8.2.5. FISH OIL‐BASED EMULSION PRODUCTS: COMPARATIVE LITERATURE SURVEY
8.2.6. COMPLICATIONS OF FISH OIL AND FISH OIL‐BASED PRODUCTS
8.2.7. REGULATORY ASPECTS RELATED TO THE SAFETY OF FISH OIL/FISH OIL‐BASED PRODUCTS
8.2.8. THERAPEUTICAL APPLICATION OF FISH OIL OR FISH OIL‐BASED NANOSIZED EMULSIONS
8.2.9. CONCLUSION
REFERENCES
INDEX
END USER LICENSE AGREEMENT
List of Tables
Chapter 1
TABLE 1.1. Typical Differences Between Grease Ball and Brick Dust Molecules
TABLE 1.2. Typical Differences Between Microemulsion and Oil‐in‐Water Nanosized E...
Chapter 2
TABLE 2.1. Comprehensive and Non‐exhaustive List of Different Conventional or Tra...
TABLE 2.2. Risk Estimation Matrix (REM) for Qualitative Analysis of Risk Construc...
TABLE 2.3. Summary of Failure Mode and Effect Analysis (FMEA) Demonstrating Risk ...
TABLE 2.4. Selective List of Various Designs Used for Optimization and Screening ...
TABLE 2.5. Taguchi Design Matrix Portraying the Layout of Various Experimental Ru...
TABLE 2.6. Independent and Dependent (Response) Variables: Face‐Centered Central ...
TABLE 2.7. Low and High Levels of Critical Material Attributes (CMAs) and Critica...
TABLE 2.8. Estimated Coded and Actual Model Equations Along with ANOVA of Regress...
Chapter 3
TABLE 3.1. Different Types of Emulsions Along with Their Compositions
TABLE 3.2. Creaming Index Values Observed for Different Emulsions Over the Period...
TABLE 3.3. Stability Testing Protocol as per ICH Guidelines
TABLE 3.4. Peak Area and UHPLC Chromatogram of Cyclosporin A (CsA) and Its Possib...
TABLE 3.5. Peak Area and UHPLC Chromatograms Obtained with the Treated Cyclospori...
TABLE 3.6. Non‐exhaustive List of Various Factors Influencing the Mean Particle S...
TABLE 3.7. List of Various Factors Influencing the Zeta Potential Value of O/W Na...
TABLE 3.8. Drug Entrapment Efficiency (DEE) % and Acetazolamide (ACZM) Amount (%)...
TABLE 3.9. Drug Entrapment Efficiency (DEE) % and Celecoxib (CXB) Amount (%) at O...
TABLE 3.10. In Vitro Release Characteristics of Celecoxib (CXB) Through Cellulose...
TABLE 3.11. Celecoxib (CXB) Release Rates Assessed by Two Different Model Equatio...
TABLE 3.12. Comparison of Acetazolamide (ACZM) Formulations in Terms of % Permeat...
TABLE 3.13. Different Parameters Investigated So Far to Assess the Safety Aspects...
TABLE 3.14. Nonanimal Test Alternatives to Draize Eye Test for Classification and...
TABLE 3.15. Schirmer I and Tear Break‐Up‐Time (TBUT) Test Values Obtained at 4‐ a...
TABLE 3.16. The Cytotoxicity Assay of the α‐Tocopherol‐Loaded and Unloaded O/W Na...
TABLE 3.17. Scoring Chart for Modified Hen’s Egg Chorioallantoic Membrane (HET‐CA...
TABLE 3.18. Scores Obtained by Various Test Formulations in Modified Hen’s Egg Ch...
TABLE 3.19. Physicochemical Characteristics of Azithromycin (AZM)‐Loaded Anionic,...
Chapter 4
TABLE 4.1. Non‐Exhaustive or Selected List of Marketed Medical and Nonmedical Emu...
TABLE 4.2. Selected List of Fatty Acids Used in Parenteral Lipid Emulsions (First...
TABLE 4.3. Influence of Dependent and Independent Variables of Both Second‐ and T...
TABLE 4.4. Steps Involved for Cancer Management Along with the Research Reported ...
TABLE 4.5. Imaging Techniques for Diagnosis of Cancer
TABLE 4.6. Typical Formula to Make Oil‐in‐Water (O/W) Anionic and Cationic Nanosi...
Chapter 5
TABLE 5.1. Volume Percentage of Various Plasma Proteins Adsorbed onto the Surface...
Chapter 7-1
TABLE 7.1.1. Commercial Products for Parenteral Administration that Contain Vitam...
Chapter 7-2
TABLE 7.2.1. Characteristics of Perfluorocarbon (PFC) Emulsions Related to the Di...
TABLE 7.2.2. Selected Commercial Examples of Perfluorocarbon (PFC)‐Based Emulsion...
Chapter 7-3
TABLE 7.3.1. Non‐comprehensive List of Oil‐in‐Water Nanosized Emulsions Used in I...
Chapter 7-4
TABLE 7.4.1. Composition of Oil‐Less Emulsion
TABLE 7.4.2. Application of Aqueous Two‐Phase Systems (ATPS)
TABLE 7.4.3. ATPS Types Along with Composition
Chapter 8-1
TABLE 8.1.1. Non‐comprehensive List of Obstacles Observed (or to Be Encountered) ...
TABLE 8.1.2. Common Molecules Used for Cation‐Conferration onto the Dispersed Oil...
TABLE 8.1.3. Specifications for Commercially Successful Cationic Nanosized Emulsi...
Chapter 8-2
TABLE 8.2.1. Non‐comprehensive List of Syndromes Manageable by Fatty Acids (Oils)...
TABLE 8.2.2. General Physical Properties of Fish Oil
TABLE 8.2.3. Effect/Performance of Fish Oil Based on Positive Therapeutic Interve...
TABLE 8.2.4. Effect/Performance of Fish Oil Based on Negative Therapeutic Interve...
TABLE 8.2.5. Brief Introduction, Advantages and Drawbacks of Different Green‐Extr...
TABLE 8.2.6. Marketed Intravenous Fat Emulsions Prepared Based on Fish Oil (FO), ...
List of Illustrations
Chapter 1
Flowchart 1.1. API sub‐categorization.
Flowchart 1.2. Critical factors to determine long‐term product stability.
Figure 1.1. Influence of emulsion droplet radius on steric stabilization....
Figure 1.2. Classification of oil‐in‐water (o/w) nanosized emulsions based o...
Chapter 2
Figure 2.1. Freeze‐dried emulsions using different cryo‐ or lyo‐protectants ...
Figure 2.2. Amount of major proteins on the 2‐D gels of plasma proteins adso...
Figure 2.3. Schematic diagram for preparation of nanosized emulsion.
Flowchart 2.1. Typical steps involved for the new drug products during their...
Flowchart 2.2. Evolution of QbD and multidimensional combination and interac...
Figure 2.4. Ishikawa fish‐bone diagram made with the help of Minitab 18 soft...
Figure 2.5. Half‐normal and Pareto charts for screening of influential formu...
Figure 2.6. Response surface plots showing the interaction effects of castor...
Figure 2.7. Derived plots obtained from 3D‐response surface model: residual ...
Chapter 3
Flowchart 3.1. Non‐exhaustive list of serially or systematically arranged va...
Figure 3.1. Influence of 6 months storage temperature (4, 25, and 37°C) cond...
Figure 3.2. Density‐ and gravitational force‐dependent/induced physical inst...
Figure 3.3. Structure of cyclosporine A.
Figure 3.4. Pictorial representation to show the behavior of charged dispers...
Figure 3.5. Essential parts of transmission electron microscope.
Figure 3.6. TEM images of emulsion samples taken at each one of the particle...
Figure 3.7. 2D and 3D AFM topography of seaweed oil nanosized emulsions.
Figure 3.8. Turbiscan
®
assembly. Key: (a) Optical scanning analyser, Tu...
Figure 3.9. Assessment of colloidal dispersion using Turbiscan
®
. Key: (...
Figure 3.10. Dynamic contact angle measurement and base width of an eye drop...
Figure 3.11.
In vitro
release of celecoxib (CXB) through cellulose acetate m...
Figure 3.12.
In vitro
cyclosporin A (CsA) release behavior at 1 : 2.5 diluti...
Figure 3.13. Azithromycin (AZM) leakage percentage observed following the st...
Figure 3.14. Acetazolamide (ACZM) amount (microgram) permeated through goat ...
Figure 3.15. Skin retention of celecoxib (CXB) from solution and anionic and...
Figure 3.16. Cumulative creatine kinase (CK) release from 150 mg of the isol...
Figure 3.17. Mean plasma creatine kinase (CK) levels versus time following t...
Figure 3.18. Hemolysis of sheep erythrocytes induced by free AZM (number 1 i...
Chapter 4
Flowchart 4.1. Year‐wise positioning of oil‐in‐water nanosized emulsions.
Flowchart 4.2. Monocytes and various subsets of tissue macrophages.
Figure 4.1. Hypothetical representation of enhanced permeability and retenti...
Figure 4.2. Schematic structure of the assembly of the multifunctional nanos...
Figure 4.3. Oil‐in‐water nanosized emulsion preparation by
de novo
method.
Chapter 5
Figure 5.1. 2‐D PAGE gel with protein adsorption pattern of Lipofundin MCT 1...
Figure 5.2. Silver‐stained 2‐D PAGE gels of emulsions with different surface...
Chapter 7-2
Figure 7.2.1. Schematic representation of droplet size growth over time in f...
Chapter 7-3
Flowchart 7.3.1. Classification of o/w nanosized emulsions based on internal...
Figure 7.3.1. Formation of Janus structure on the dispersed oil droplets of ...
Figure 7.3.2. Optical microscopic picture showing the Janus structure on the...
Figure 7.3.3. Emulsion with Cerberus structure on the dispersed oil droplets...
Figure 7.3.4. Overview of current mouse models of atherosclerosis. This figu...
Chapter 7-4
Flowchart 7.4.1. Classification of emulsion‐like dispersions.
Figure 7.4.1. Schematic ternary phase diagrams, which illustrate (a) segrega...
Figure 7.4.2. Schematic representation of the phase diagram. Concentrations ...
Chapter 8-2
Flowchart 8.2.1. Commonly available various types of fish oil and their sour...
Guide
Cover
Table of Contents
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OIL‐IN‐WATER NANOSIZED EMULSIONS FOR DRUG DELIVERY AND TARGETING
TAMILVANAN SHUNMUGAPERUMAL
Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER)Guwahati, Assam, India
This edition first published 2021© 2021 John Wiley & Sons, Inc.
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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–dc23LC record available at https://lccn.loc.gov/2021019779LC ebook record available at https://lccn.loc.gov/202101978
Cover Design: WileyCover 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, oil or oil combination, and other ingredients to systematically optimize the emulsion formula matching with ICH guidelines Q8(R2), Q9, and Q10, to characterize the emulsions and perform safety assessment, to monitor the biofate of nanosized emulsions, etc. All these abovesaid issues are detailed in this book with few case studies wherever possible.
Chapter 1 starts with terminology confusion prevailing about emulsion in medical and pharmaceutical fields. The purpose of this section is to clarify the terminology needed to indicate authentically this drug delivery/targeting system and finally gives reasons for judicious selection of the term “nanosized emulsion.” It will also provide generations of oil‐in‐water nanosized emulsions so far developed with short justification followed by a brief description regarding the purpose and contents of the book.
Chapter 2 introduces the quality‐by‐design (QbD) approach applied onto the emulsion optimization during the preformulation studies. The effect of amount of NCE or lipophilic drug, quantity of excipients (oils, emulsifiers, and other excipients) onto the drug incorporation patterns, final particle size distribution of dispersed oil droplets of the emulsion, stability of final emulsion over different temperature conditions, etc., are the subject of interest discussed in this chapter.
Chapter 3 provides an overview of how nanosized emulsions are serially or systematically characterized to meet the requirements against physical, chemical, biological, and safety points of view. Safety evaluations using animal or human volunteers and cell‐culture models are separately discussed in terms of the requirements needed by the regulatory agencies for allowing the emulsions to undergo clinical trials and then, commercial usage.
Chapter 4 shows how changes in terms of formulation excipients were being constantly made on the nanosized emulsions over the last few decades. To understand better this changeover process, the o/w nanosized emulsions are classified based on the generations with decade‐wise gap.
Chapter 5 arranges the various issues relevant to the o/w nanosized emulsions to implicate in parenteral and ocular drug delivering systems. Understanding the mechanisms of interactions between emulsion droplets and plasma protein components helps the formulation developers to design long‐circulating stealth emulsions for parenteral drug delivery and drug targeting purposes. Similar attention is also being given to the consequences of nanosized emulsions following ocular topical instillation or intraocular injection. The published reports in conjunction with these points are covered thoroughly in this chapter.
Chapter 6 starts with a narrative on how the emulsion surfaces can possibly be decorated with different functional molecules for the purpose of extracting a multifunctional activity in a single drug delivery and drug targeting system. Various medical applications of emulsions achieved/obtained through different administration routes are discussed in detail in this chapter.
Chapter 7 intends to provide an overview of some selected and miscellaneous uses of nanosized emulsions to interface with the recent application.
Chapter 8 describes the various steps ranging from laboratory level manufacturing together with safety aspects evaluation in animal and human eyes to industrial scaleup and then successful commercialization of cyclosporin A‐loaded nanosized emulsions. Other case study included in this chapter is fish oil‐based emulsions.
With these collective information, this book serves as a guide for emulsion formulation developers working in academic environment and at the industrial level.
Tamilvanan Shunmugaperumal
