The book provides a systematic understanding of various novel drug delivery systems and their preparation, characterization and impressive range of applications.
Table of ContentsPreface xxi
Part 1: Introduction to the Fundamentals 1
1 Lipid-Based Nanocarriers as Drug Delivery System and Its Applications 3
Vikas Jain, Hitesh Kumar, Pallavi Chand, Sourabh Jain and Preethi S
List of Abbreviations 3
1.1 Introduction 4
1.2 An Overview on Nanocarriers 5
1.3 Types of Nanocarriers 6
1.3.1 Liposomes 6
1.3.2 Solid Lipid Nanoparticles 7
1.3.3 Nanostructured Lipid Carriers System 7
1.3.4 Nanoemulsion 9
1.3.5 SMEDDS, SEDDS, and SNEDDS 9
1.3.6 Crystalline Mesophases 10
1.4 Methods of Preparation of Lipid Nanocarriers 12
1.5 Challenges and Hurdles 12
1.5.1 Scale Up and Stability Issues 12
1.5.2 In Vivo Elimination of Nanocarriers 14
1.6 Characterization Techniques for Lipid Nanocarriers 14
1.6.1 Size and Morphology 14
1.6.2 Surface Charge 15
1.6.3 Thermal Analysis 16
1.6.4 X-Ray Diffraction 16
1.6.5 Spectroscopic Analysis 16
1.7 Application of Lipid-Based Nanocarriers 17
1.7.1 Application in Drug Delivery 17
1.7.2 Application in Therapeutic Nucleic Acid Delivery 18
1.7.3 Application in Delivery of Peptide/Hormone 19
1.8 Conclusion 19
References 20
2 Nanoparticulate Carriers—Versatile Delivery Systems 31
Ruchi Chawla, Varsha Rani and Mohini Mishra
List of Abbreviations 31
2.1 Introduction 32
2.2 Classification of Nanoparticulate Carriers 33
2.2.1 Lipid-Based Nanocarriers 33
2.2.1.1 pH-Sensitive Lipid Carriers 37
2.2.1.2 Thermo-Responsive Lipid Carriers 38
2.2.2 Micellar Systems 39
2.2.3 Theranostics 39
2.2.3.1 Gold Nanoparticles (AuNPs) 39
2.2.3.2 Iron Oxide Nanoparticles 40
2.2.3.3 Quantum Dots 40
2.2.4 Self-Emulsifying Drug Delivery Systems (SEDDS) 41
2.2.5 Polymer-Based Nanoparticles 41
2.3 Various Applications of Nanoparticulate Carriers 43
2.3.1 Tissue Engineering and Regenerative Medicine 43
2.3.2 Delivery of Proteins 44
2.3.3 Delivery of Vaccines 44
2.3.4 Gene Therapy 44
2.3.5 Phagokinetic Studies 45
2.4 Modes of Transport of Nanoparticulate Carriers 45
2.5 Conclusion 48
References 48
3
Nanotools in Customized Drug Delivery SystemThirumalai Subramaniam K J, Gowthamarajan Kuppusamy,Arun Radhakrishnan and Veera Venkata Satyanarayana Reddy Karri
List of Abbreviations 55
3.1 Introduction 56
3.2 Concept of Personalized Medicines 57
3.3 Customized Nanotools and Their Benefits 60
3.3.1 Liposomes 64
3.3.2 Solid Lipid Nanoparticles (SLNs) 65
3.3.3 Nanocarbon Tubes 66
3.3.4 Polymer-Based Nanoparticles 66
3.3.5 Polymer-Based Micelles 66
3.3.6 Dendrimers 67
3.3.7 Metallic Nanoparticles 68
3.3.7.1 Gold Nanoparticles 68
3.3.7.2 Iron Oxide Nanoparticles 69
3.3.8 Quantum Dots 69
3.3.9 Nanodiamonds 69
3.4 Applications of Nanotechnology in Personalized Medicine 70
3.5 Future Perceptions 73
3.6 Conclusion 74
Part 2: Novel and Modernized Nanoscale Delivery Systems: Revolutionary Progress in the Field of Pharmacy 79
4 Dendrimers: Role in Novel Drug Delivery 81
Pooja Mittal, Ramit Kapoor and Brahmeshwar Mishra
List of Abbreviations 81
4.1 Introduction 81
4.1.1 Advantages of Dendrimers 82
4.1.2 Role of Dendrimers in Drug Delivery 82
4.2 Components of Dendrimers 83
4.3 Synthesis of Dendrimers 84
4.4 Classification of Dendrimers 84
4.4.1 Hydrophilic Dendrimers 85
4.4.2 Biodegradable Dendrimers 85
4.4.3 Dendrimers with Amino Acids 85
4.4.4 Glycodendrimers 86
4.4.5 Hydrophobic Dendrimers 86
4.4.6 Asymmetric Dendrimers 86
4.4.7 Simple Dendrimers 86
4.4.8 Liquid Crystalline Dendrimers 87
4.4.9 Chiral Dendrimers 87
4.4.10 Micellar Dendrimers 87
4.4.11 Hybrid Dendrimers 87
4.4.12 Amphiphilic Dendrimers 87
4.4.13 Metallodendrimers 87
4.4.14 Tectodendrimers 87
4.4.15 Multilingual Dendrimers 88
4.4.16 Multiple Antigen Peptide Dendrimers 88
4.5 Properties of Dendrimers 88
4.6 Mechanism of Drug Entrapment in Dendrimers 89
4.6.1 Physical Encapsulation of the Drugs 90
4.6.2 Electrostatic Interactions 90
4.6.3 Covalent Conjugations 90
4.7 Dendrimers as Delivery Agents 91
4.7.1 Dendrimers as Oral Drug Delivery System 91
4.7.2 Dendrimers in Nasal Drug Delivery 93
4.7.3 Dendrimers as Carriers for Anticancer Treatment and Diagnosis 93
4.7.3.1 Dendrimers as Carriers for Anticancer Drugs 93
4.7.3.2 Dendrimers as Diagnostic Agents Cancer 94
4.8 Conclusion 94
5 Nanofibers in Drug DeliveryDipak Kumar Sahu, Goutam Ghosh and Goutam Rath
List of Abbreviations 99 5.1 Introduction 101
5.2 Nanofiber as Oral Drug Delivery System 109
5.3 Nanofiber as Topical Drug Delivery System 110
5.4 Nanofiber as Parenteral Drug Delivery System 112
5.5 Nanofiber as Multimodal Drug Delivery System 112
5.5.1 Cardiovascular Disorder 112
5.5.2 Stent Coating 113
5.5.3 Hormone 113
5.5.4 Vitamins 113
5.5.5 Probiotic 114
5.5.6 Antimicrobial Therapy 114
5.5.7 Cancer 115
5.5.8 Contraceptive 116
5.5.9 Antihistamine 117
5.5.10 Trauma 117
5.6 Challenges and Future Perspective 118
5.7 Conclusion 118
References 118
6 Microbubbles used for Drug Delivery System Hemraj Heer, Vishav Prabhjot Kaur, Sandeep Rathor, Sheikh Aamir
List of Abbreviations 125
6.1 Introduction 126
6.2 Structural Components of Microbubble 127
6.2.1 Innermost Core 128
6.2.2 Shell Materials 128
6.2.2.1 Protein Shells 128
6.2.2.2 Surfactant Shells 128
6.2.2.3 Lipid-Coated MBs 128
6.2.2.4 Polymer Shells 129
6.3 Methods of Preparation Microbubbles 130
6.3.1 Sonication Technique 130
6.3.2 Cross-Linked Polymer Technique 130
6.3.3 Emulsion Solvent Evaporation Technique 131
6.3.4 Atomization and Reconstitution Technique 132
6.4 Acoustic Nature of Microbubble 132
6.4.1 Response Under Low Frequency 132
6.4.2 Response Under High Frequency 133
6.5 Characterizations of Microbubbles 133
6.5.1 Determination of Bubble Size 133
6.5.2 Determination of Bubble Densities 134
6.5.3 In Vitro Floating Properties 134
6.5.4 Microscope Observation and Diameter Measurement 6.5.5 MB Diameter Measurement 135
6.5.6 MB Concentration Determination 135
6.5.7 Acoustic Stability of MBs 135
6.6 Applications of Microbubbles 135
6.6.1 Diagnostic Applications of Microbubble 136
6.6.2 Therapeutic Potential of Microbubbles 137
6.7 Conclusions and Future Prospective 139
References 139
7 Virosomes: A Viral Envelope System Having a Promising Application in Vaccination and Drug Delivery SystemAnkit Kalra and Shilpa Sharma
List of Abbreviations 145
7.1 Introduction 146
7.2 What are Virosomes? 147
7.3 Comparison of Virosomes With Liposomes 148
7.4 Methods of Preparation of Virosomes 148
7.4.1 Selection of Virus 148
7.4.2 Selection of Compound of Interest (Antigen/Drug/Macromolecule) 149
7.4.3 Membrane Reconstitution 149
7.5 Characterization of Virosomes 149
7.6 Applications of Virosomal Technology 150
7.6.1 Virosomes for Vaccination 151
7.6.1.1 Virosomes for Antigen Delivery 151
7.6.1.2 Virosomes as Adjuvants in Human Vaccine Formulations 152
7.6.1.3 Virosomes Complexed With Adjuvants 153
7.6.1.4 Some Commercial Virosome-Based Vaccines 154
7.6.2 Virosomes for Drug Delivery 154
7.6.3 Virosomes for Cancer Immunotherapy 155
7.7 Conclusion 157
References 157
8 Nanocarriers: A Tool for Effective Gene DeliveryRita N. Wadetwar and Amita P. Godbole
List of Abbreviations 161
8.1 Introduction 162
8.2 Key Steps in Gene Delivery 163
8.3 Success and Existing Challenges for Gene Delivery 163
8.4 In Vitro and In Vivo Barriers Towards Successful Gene Transfer 164
8.5 Genetic Material That can be Delivered in Gene Therapy 165
8.6 Role of Nanocarriers in a Nucleic Acid Delivery 165
8.7 Nanocarriers used for Delivering Gene 166
8.7.1 Polymeric Nanocarriers 166
8.7.2 Lipid Nanocarriers 166
8.7.3 Protein Nanocarriers for Gene Delivery 169
8.7.4 Magnetic Nanocarriers 170
8.7.5 Gold Nanocarrier 171
8.7.6 Quantum Dots 172
8.7.7 Dendrimers 172
8.7.8 Stimuli Responsive Nanocarriers 173
8.7.9 pH Sensitive Liposomes 174
8.7.10 Temperature Responsive Nanocarriers 174
8.7.11 Redox Sensitive Nanocarriers 175
8.8 Cellular Uptake of Nanocarriers and Their Fate Inside the Cell 175
8.8.1 Cellular Uptake and Intracellular Trafficking of NPs 175
8.9 Physicochemical Properties of Nanoparticles Affecting Their Uptake 176
8.10 Targeted Delivery of Genes Using Nanocarriers 177
8.11 Virosomes 177
8.12 Exosomes 178
8.13 Diseases Cured by Gene Therapy 180
8.14 Clinical Trials 180
8.15 Current Trends and Approved Products 180
8.16 Concluding Remarks 183
References 183
9 Phytosomes—Nanoarchitectures’ Promising Clinical Applications and Therapeutics 187
Pankaj Pal, Vivek Dave, Shailendra Paliwal, Monika Sharma,
Mrugendra B. Potdar and Avnica Tyagi
List of Abbreviations 187
9.1 Introduction 188
9.1.1 Phytosomes 189
9.2 Structure of Phytosomes 189
9.3 Components of Phytosomes 190
9.3.1 Phyto-Active Ingredients 190
9.3.2 Phospholipids 191
9.3.3 Stoichiometric Ratio of Phospholipids and Active Phyto-Constituents 191
9.3.4 Solvents 192
9.4 Synthesis of Phytosomes 192
9.4.1 Methods 192
9.5 Characterization of Phytosomes 193
9.5.1 Morphological Visualization 193
9.5.2 Stability of Vesicles 193
9.5.3 Zeta Potential and Vesicle Size 194
9.5.4 Transition Temperature 194
9.5.5 Surface Tension 194
9.5.6 Entrapment Efficiency 195
9.5.7 Partition Co-Efficient and Solubility 195
9.5.8 Spectroscopic Approaches 195
9.5.8.1 Fourier Transform Infrared Spectroscopy (FTIR) 195
9.5.8.2 Nuclear Magnetic Resonance (NMR) 195
9.6 Absorption Mechanism of Phytosomes 196
9.7 Applications of Phytosomes 196
9.7.1 Phytosomes in Cancer Therapy 197
9.7.2 Phytosomes in Diabetes 198
9.7.3 Phytosomes in Brain Delivery 199
9.7.4 Phytosomes in Wound Healing 199
9.7.5 Phytosomes in Liver Diseases 200
9.8 Recent Trends and Advancements in Phytosomal Delivery 200
9.9 Future Perspectives 208
9.10 Conclusion 209
References 210
10 Saponin Stabilized Emulsion as Sustainable Drug Delivery System: Current Status and Future Prospects 217
Priyanka Yatham, Yogita Dahat, Arshad Khan, Rinku Baishya, Amit K. Srivastava and Deepak Kumar
List of Abbreviations 217
10.1 Introduction 218
10.2 Saponins as Surfactant 219
10.2.1 Quillaja saponaria 219
10.2.2 Sapindus mukorossi 223
10.2.3 Glycyrrhiza glabra 224
10.2.4 Panax ginseng 225
10.2.5 Tea Saponins 226
10.2.6 Aesculus hippocastanum 227
10.2.7 Yucca schidigera 227
10.2.8 Verbascum nigrum 228
10.2.9 Saponaria officinalis 228
10.3 Pharmaceutical Advantages 229
10.4 Conclusion and Future Prospects 230
References 231
11 Mono and Multi-Stimuli Responsive Polymers: Application as Intelligent Nano-Drug Delivery Systems 237
Archana Sidagouda Patil, Anand Panchakshari Gadad and Panchaxari Mallappa Dandagi
List of Abbreviations 237
11.1 Introduction 238
11.2 Smart or Stimuli-Responsive Polymers for Drug Delivery 240
11.2.1 Mono-Stimuli Responsive Polymers 240
11.2.2 Dual-Stimuli Responsive Polymers 240
11.2.3 Multi-Responsive Polymers 240
11.2.4 pH Responsive Polymers and Delivery Systems 240
11.2.5 Temperature Responsive Polymers in Drug Delivery 244
11.2.6 Light Responsive Drug Delivery Systems 245
11.2.7 Magnetically Responsive Polymeric Drug Delivery Systems 248
11.2.7.1 Static (Constant) Field Systems 248
11.2.7.2 Varying Magnet Field Systems (VMFS) 249
11.2.8 Other Stimuli Responsive Polymeric Nanoparticles 249
11.3 Dual and Multi-Stimuli Responsive Drug Delivery Systems 251
11.4 Conclusion 257
References 257
12 An Insight into Nanosomes: Potential Nanopharmaceutical Delivery SystemTrishna Bal, Sandeep Garg, Aditya Dev Rajora, Shubha Rani Sharma and Harshita Harsh
List of Abbreviations 267
12.1 Introduction 268
12.2 General Methods of Preparation of Nanosomes and Drug Loading 271
12.3 Trafficking Mechanism in the Body 273
12.4 Sterilization of Nanosomes 275
12.5 Evaluation Parameters 275
12.5.1 Determination of Particle Size 275
12.5.2 Determination of Zeta Potential 275
12.5.3 Morphological Study 276
12.5.4 In Vitro Release Studies 276
12.5.5 Determination of Encapsulation Efficiency 276
12.5.6 Re-Dispersibility 276
12.5.7 Stability on Storage 276
12.6 Applications 276
12.7 Conclusion 279
References 279
13 Nano-Structures as Bioelectronics for Controlled Drug DeliveryDebabrata Ghosh Dastidar, Dipanjan Ghosh and Gopal Chakrabarti
List of Abbreviations 285
13.1 Introduction 287
13.2 Electroactive Biopolymer of Conductive Polymers 290
13.3 Electrochemical Desorption From Micro and Nanostructures
13.4 Electrochemical Desorption From Micro and Nano-Composites of Conductive Polymers 295
13.5 Electrochemical Desorption of Self-Assembled Monolayer from a Gold Surface 297
13.7 Biochemical Release Controlled by Electrochemical Erosion
13.9.3 Electrically Driven Nanomotors 303
13.10 Conclusion and Future Aspects 304
References 305
14 Bioadhesive Nanoparticulate Drug Delivery System 309
Rajashree Shashidhar Masareddy, Archana Sidagouda Patil and Anand Panchakshari Gadad
List of Abbreviations 309
14.1 Introduction 310
14.2 Mucous Membrane 311
14.3 Mucoadhesive Forces 311
14.4 Theories of Mucoadhesion 313
14.4.1 Electronic Theory 313
14.4.2 Adsorption Theory 314
14.4.3 Wetting Theory 314
14.4.4 Diffusion Theory 314
14.5 Mechanism of Mucoadhesion 315
14.6 Polymers Used to Prepare Mucoadhesive Nanoparticles 315
14.7 Ideal Properties of Mucoadhesive Polymers 317
14.8 Mucoadhesion of Nanoparticles 318
14.9 Preparation Methods of Mucoadhesive Polymeric Nanoparticles 319
14.9.1 Solvent Displacement Method 319
14.9.2 Surface Modification of Nanoparticles With Mucoadhesive Polymers 320
14.9.3 Emulsion Polymerization 321
14.10 Evaluation of Mucoadhesive Systems 322
14.10.1 In Vitro and Ex Vivo Tests 322
14.10.2 Measurement of Tensile Strength 323
14.10.3 Measurement of Detachment Force 323
14.10.4 Falling Liquid Film Method 323
14.10.5 Colloidal Gold Staining Method 323
14.10.6 Biacore System 324
14.10.7 Confocal Laser Scanning Microscopic (CLSM) Method 324
14.10.8 In Vivo Methods 324
14.10.8.1 Gamma Scintigraphy 324
14.10.8.2 X-Ray (GI Transit Time) Studies 324
14.10.8.3 Isolated Loop Technique 325
14.11 Evaluation Tests of Mucoadhesive Nanoparticulate Systems 325
14.11.1 Adhesion Test 325
14.11.2 Atomic Force Microscopy 325
14.11.3 Fluorophotometric Evaluation 326
14.12 Applications 326
14.13 Conclusion 327
References 327
Part 3: Understanding Targeted Delivery Systems 333
15 Nanopharmaceuticals: An Approach for Effective Management of Breast Cancer 335
Veena S. Belgamwar, Suchitra S. Mishra, Vidyadevi T. Bhoyar and Kunal B. Banode
List of Abbreviations 335
15.1 Introduction 336
15.2 Stages of Breast Cancer 337
15.3 Main Types of Breast Cancer 337
15.4 Drawbacks in Conventional Treatment 338
15.5 Nanoparticulate Approach for Effective Management of Breast Cancer 339
15.6 Systematic Drug Delivery System Approaches 341
15.6.1 Metallic Nano Drug Carrier 341
15.6.1.1 Magnetic Nanoparticles 341
15.6.1.2 Gold Nanoparticles 341
15.6.1.3 Superparamagnetic Iron Oxide (SPIO) 341
15.6.2 Polymer-Based Drug Carriers 342
15.6.2.1 Polymeric Nanoparticles 342
15.6.2.2 Polymeric Micelles 342
15.6.2.3 Dendrimers 343
15.6.3 Drug Carriers Based on Lipid 343
15.6.3.1 Liposomes 343
15.6.4 Viral Nanoparticles 343
15.6.5 Carbon Nanotubes 344
15.7 Nanoparticles Targeted Drug Delivery 344
15.7.1 Morphology of Nanoparticles 345
15.7.1.1 Size 345
15.7.1.2 Surface Characteristics 345
15.7.2 Passive Targeting 345
15.7.2.1 Increase Permeability and Retention Time 345
15.7.2.2 Tumor Physiology 346
15.7.3 Active Targeting 346
15.7.3.1 Antigen or Receptor Expression 347
15.7.3.2 Internalization of Targeted Conjugates 347
15.8 Various Ligands used for Targeting Cancer Cells 347
15.8.1 Folate 347
15.8.2 Aptamer 347
15.8.3 Transferrin 348
15.8.4 Lectins 348
15.8.5 Reverselectin 349
15.8.6 Epidermal Growth Factor Receptor (EGFR) 349
15.8.7 Quantum Dots (QD) 349
15.8.8 Si RNA 349
15.9 New Innovative Pharmaceutical Entities and Targeting Moieties 349
15.10 Future of Cancer Treatment in Nanotechnology 350
15.11 Conclusion 351
References 351
16 Vaginal Nano-Based Drug Delivery System 357
Rita N. Wadetwar and Pranita S. Kanojiya
List of Abbreviation 357
16.1 Introduction 358
16.2 Vaginal Anatomy Physiology and Diseases of Vagina 359
16.2.1 Physiology of Vagina 359
16.2.2 Vaginal Infections 360
16.3 Advantages of Vaginal Drug Delivery 361
16.4 Drawbacks of Conventional Vaginal Formulation 362
16.5 Need of Nanocarriers for Vaginal Delivery 363
16.6 Different Types of Nanoparticles for Vaginal Therapy 363
16.6.1 Concept of pH-Sensitive Nanoparticles 364
16.6.2 Acid Labile Products (Nucleic Materials/Proteins/Peptides) 365
16.6.3 Mucoadhesive Nanoparticles 365
16.6.4 Mucous-Penetrating Nanoparticles 366
16.6.5 PEGylated Nanoparticles 366
16.6.6 Dendrimers 366
16.6.7 Liposomes 367
16.6.8 Niosomes 367
16.6.9 Nanoemulsion 367
16.6.10 Metallic Nanoparticles 367
16.6.11 Diagnostic Nanoparticles 371
16.7 Vaginal Patents 371
16.8 Nanotoxicity: Future Prospective 373
16.9 Conclusion 374
References 374
17 Recent Advances in Polymer-Modified Liposomes for Cancer Treatment 379
Swapnil Sharma, Akansha Bisht, Sanjana Tewari and Vivek Dave
List of Abbreviations 379
17.1 Introduction 380
17.2 Liposomes 380
17.2.1 Structure of Liposomes 380
17.2.2 Classification of Liposomes 381
17.2.3 Preparation of Liposomes 381
17.2.4 Drug Encapsulation Into Liposomes 382
17.2.4.1 Active Loading of a Drug Into Liposome 382
17.2.4.2 Passive Loading of a Drug Into Liposome 383
17.2.5 Mechanism of Liposomes 383
17.2.6 Liposomes in Cancer Treatment 384
17.2.7 Liposomal Formulations Available in Clinical Trials for Cancer Treatment 384
17.2.8 Liposomes Targeting Cancerous Cells 388
17.2.8.1 Liposome Mediated Active Targeting of Cancer Cells 388
17.2.8.2 Liposome Mediated Passive Targeting of Cancer Cells 390
17.2.9 Strategies for Targeting Liposomes at Cancer Specific Site 391
17.2.9.1 Increased Permeability & Retention (EPR) Effect and their Application in Cancer Treatment 391
17.2.9.2 Surface Engineered Liposomes Mediated Active Targeting with Functionalized Targeting Ligands 392
17.2.10 Approaches for Enhanced Delivery of Chemotherapeutic Drugs at Tissue Specific Site via Functionalized Liposomes Responsive Towards Stimuli 393
17.2.10.1 Liposomes Responsive to Temperature 393
17.2.10.2 Liposomes Responsive to pH 395
17.2.10.3 Liposomes Responsive to Magnetic Field 395
17.2.10.4 Liposomes Responsive to Ultrasound 395
17.2.11 Role of Polymers in Drug Delivery for the Treatment of Cancer 395
17.3 Future Challenges Associated With Cancer Therapy 401
17.4 Conclusion 402
References 402
18 Role of Nanomedicines in Neglected Tropical Diseases 407
Rahul Shukla, Atul Mourya, Mayank Handa and Rewati Raman Ujjwal
List of Abbreviations 407
18.1 Introduction 408
18.2 Diseases 409
18.2.1 Buruli Ulcer 409
18.2.1.1 Current Therapeutics for Buruli Ulcer 410
18.2.1.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Buruli Ulcer 410
18.2.2 Chagas Disease 410
18.2.2.1 Current Treatment for Chagas Disease 411
18.2.2.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Chagas Disease 412
18.2.3 Cysticercosis 413
18.2.3.1 Current Treatment for Cysticercosis 413
18.2.3.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Cysticercosis 414
18.2.4 Dengue Fever 414
18.2.4.1 Current Treatment for Dengue Fever 414
18.2.4.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Dengue Fever 415
18.2.5 Dracunculosis 415
18.2.5.1 Current Treatment for Dracunculosis 415
18.2.5.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Dracunculosis 416
18.2.6 Echinococcosis 416
18.2.6.1 Current Treatment for Echinococcosis 416
18.2.6.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Echinococcosis 417
18.2.7 Fascioliasis 417
18.2.7.1 Current Treatment for Fascioliasis 417
18.2.7.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Fascioliasis 418
18.2.8 Foodborne Trematodes 418
18.2.8.1 Current Treatment for Foodborne Trematodes 419
18.2.8.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Foodborne Trematodes 419
18.2.9 Human African Trypanosomiasis 419
18.2.9.1 Current Treatment for Human African Trypanosomiasis 420
18.2.9.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Human African Trypanosomiasis 420
18.2.10 Leishmaniasis 421
18.2.10.1 Current Treatment for Leishmaniasis 421
18.2.10.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Leishmaniasis 421
18.2.11 Leprosy 423
18.2.11.1 Current Treatment for Leprosy 423
18.2.11.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Leprosy 423
18.2.12 Lymphatic Filariasis 424
18.2.12.1 Current Treatment for Lymphatic Filariasis 424
18.2.12.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Lymphatic Filariasis 424
18.2.13 Mycetoma, Chromoblastomycosis and Other Deep Mycoses 425
18.2.13.1 Current Treatment for Mycetoma, Chromoblastomycosis and Other Deep Mycoses 425
18.2.13.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Mycetoma, Chromoblastomycosis and Other Deep Mycoses 425
18.2.14 Onchocerciasis 425
18.2.14.1 Current Treatment for Onchocerciasis 427
18.2.14.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Onchocerciasis 427
18.2.15 Rabies 427
18.2.15.1 Current Treatment for Rabies 428
18.2.15.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Rabies 428
18.2.16 Schistosomiasis 428
18.2.16.1 Current Treatment for Schistosomiasis 428
8.2.16.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Schistosomiasis 429
18.2.17 Snakebite Envenoming 429
18.2.18 Soil-Transmitted Helminthiases 430
18.2.18.1 Treatment for Soil-Transmitted Helminthiases 430
18.2.18.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Soil-Transmitted Helminthiases 430
18.2.19 Trachoma 430
18.2.19.1 Treatment for Trachoma 431
18.2.19.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Trachoma 431
18.2.20 Yaws 432
18.2.20.1 Treatment for Yaws 432
18.2.20.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Yaws 432
18.3 Conclusion 432
Acknowledgement 437
References 438
Part 4: Overview of Regulatory Affairs 447
19 Current Framework, Ethical Consideration and Future Challenges of Regulatory Approach for Nano-Based Products 449
Vivek Dave, Srija Sur and Nikita Gupta
List of Abbreviations 449
19.1 Introduction 450
19.2 Issues in Aspect of Regulation of Drug Delivery System 451
19.2.1 Environmental, Health and Safety Risks 451
19.2.2 Ethical, Legal and Social Issues 451
19.3 Regulation of Nano-Based Products in Global Realms of the World 452
19.3.1 United States 453
19.3.1.1 Agency of US Environmental Protection 453
19.3.1.2 United States of Food and Drug Administration 454
19.3.2 United Kingdom 454
19.3.3 European Union (EU) 455
19.3.3.1 Progress of Regulatory Measures in European Union 456
19.3.4 Australia 457
19.3.5 Canada 458
19.3.6 Other Countries 458
19.4 Regulatory Challenges and Solutions in DDS Development 458
19.4.1 Classification 467
19.4.2 Chemistry, Manufacturing and Control 467
19.4.3 Non-Clinical Safety 468
19.4.4 Clinical Studies and Post Marketing Surveillance 468
19.5 Regulatory Education and its Involvement in Pharmaceutical Industry for the Development of Novel Drug Delivery Systems 469
19.6 Current Framework and Future Challenges 469
19.7 Conclusion 470
References 471
Index 473
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