Оглавление
Группа авторов. Nanopharmaceutical Advanced Delivery Systems
Table of Contents
List of Illustrations
List of Tables
Guide
Pages
Nanopharmaceutical Advanced Delivery Systems
Preface
1. Lipid-Based Nanocarriers as Drug Delivery System and Its Applications
List of Abbreviations
1.1 Introduction
1.2 An Overview on Nanocarriers
1.3 Types of Nanocarriers. 1.3.1 Liposomes
1.3.2 Solid Lipid Nanoparticles
1.3.3 Nanostructured Lipid Carriers System
1.3.4 Nanoemulsion
1.3.5 SMEDDS, SEDDS, and SNEDDS
1.3.6 Crystalline Mesophases
1.4 Methods of Preparation of Lipid Nanocarriers
1.5 Challenges and Hurdles. 1.5.1 Scale Up and Stability Issues
1.5.2 In Vivo Elimination of Nanocarriers
1.6 Characterization Techniques for Lipid Nanocarriers. 1.6.1 Size and Morphology
1.6.2 Surface Charge
1.6.3 Thermal Analysis
1.6.4 X-Ray Diffraction
1.6.5 Spectroscopic Analysis
1.7 Application of Lipid-Based Nanocarriers. 1.7.1 Application in Drug Delivery
1.7.2 Application in Therapeutic Nucleic Acid Delivery
1.7.3 Application in Delivery of Peptide/Hormone
1.8 Conclusion
References
2. Nanoparticulate Carriers— Versatile Delivery Systems
List of Abbreviations
2.1 Introduction
2.2 Classification of Nanoparticulate Carriers
2.2.1 Lipid-Based Nanocarriers
2.2.1.1 pH-Sensitive Lipid Carriers
2.2.1.2 Thermo-Responsive Lipid Carriers
2.2.2 Micellar Systems
2.2.3 Theranostics
2.2.3.1 Gold Nanoparticles (AuNPs)
2.2.3.2 Iron Oxide Nanoparticles
2.2.3.3 Quantum Dots
2.2.4 Self-Emulsifying Drug Delivery Systems (SEDDS)
2.2.5 Polymer-Based Nanoparticles
2.3 Various Applications of Nanoparticulate Carriers
2.3.1 Tissue Engineering and Regenerative Medicine
2.3.2 Delivery of Proteins
2.3.3 Delivery of Vaccines
2.3.4 Gene Therapy
2.3.5 Phagokinetic Studies
2.4 Modes of Transport of Nanoparticulate Carriers
2.5 Conclusion
References
3. Nanotools in Customized Drug Delivery System
List of Abbreviations
3.1 Introduction
3.2 Concept of Personalized Medicines
3.3 Customized Nanotools and Their Benefits
3.3.1 Liposomes
3.3.2 Solid Lipid Nanoparticles (SLNs)
3.3.3 Nanocarbon Tubes
3.3.4 Polymer-Based Nanoparticles
3.3.5 Polymer-Based Micelles
3.3.6 Dendrimers
3.3.7 Metallic Nanoparticles
3.3.7.1 Gold Nanoparticles
3.3.7.2 Iron Oxide Nanoparticles
3.3.8 Quantum Dots
3.3.9 Nanodiamonds
3.4 Applications of Nanotechnology in Personalized Medicine
3.5 Future Perceptions
3.6 Conclusion
References
4. Dendrimers: Role in Novel Drug Delivery
List of Abbreviations
4.1 Introduction
4.1.1 Advantages of Dendrimers
4.1.2 Role of Dendrimers in Drug Delivery
4.2 Components of Dendrimers
4.3 Synthesis of Dendrimers
4.4 Classification of Dendrimers
4.4.1 Hydrophilic Dendrimers
4.4.2 Biodegradable Dendrimers
4.4.3 Dendrimers with Amino Acids
4.4.4 Glycodendrimers
4.4.5 Hydrophobic Dendrimers
4.4.6 Asymmetric Dendrimers
4.4.7 Simple Dendrimers
4.4.8 Liquid Crystalline Dendrimers
4.4.9 Chiral Dendrimers
4.4.10 Micellar Dendrimers
4.4.11 Hybrid Dendrimers
4.4.12 Amphiphilic Dendrimers
4.4.13 Metallodendrimers
4.4.14 Tectodendrimers
4.4.15 Multilingual Dendrimers
4.4.16 Multiple Antigen Peptide Dendrimers
4.5 Properties of Dendrimers
4.6 Mechanism of Drug Entrapment in Dendrimers
4.6.1 Physical Encapsulation of the Drugs
4.6.2 Electrostatic Interactions
4.6.3 Covalent Conjugations
4.7 Dendrimers as Delivery Agents
4.7.1 Dendrimers as Oral Drug Delivery System
4.7.2 Dendrimers in Nasal Drug Delivery
4.7.3 Dendrimers as Carriers for Anticancer Treatment and Diagnosis
4.7.3.1 Dendrimers as Carriers for Anticancer Drugs
4.7.3.2 Dendrimers as Diagnostic Agents for Cancer
4.8 Conclusion
References
5. Nanofibers in Drug Delivery
List of Abbreviations
5.1 Introduction
5.2 Nanofiber as Oral Drug Delivery System
5.3 Nanofiber as Topical Drug Delivery System
5.4 Nanofiber as Parenteral Drug Delivery System
5.5 Nanofiber as Multimodal Drug Delivery System. 5.5.1 Cardiovascular Disorder
5.5.2 Stent Coating
5.5.3 Hormone
5.5.4 Vitamins
5.5.5 Probiotic
5.5.6 Antimicrobial Therapy
5.5.7 Cancer
5.5.8 Contraceptive
5.5.9 Antihistamine
5.5.10 Trauma
5.6 Challenges and Future Perspective
5.7 Conclusion
References
6. Microbubbles used for Drug Delivery System
List of Abbreviations
6.1 Introduction
6.2 Structural Components of Microbubble
6.2.1 Innermost Core
6.2.2 Shell Materials. 6.2.2.1 Protein Shells
6.2.2.2 Surfactant Shells
6.2.2.3 Lipid-Coated MBs
6.2.2.4 Polymer Shells
6.3 Methods of Preparation Microbubbles. 6.3.1 Sonication Technique
6.3.2 Cross-Linked Polymer Technique
6.3.3 Emulsion Solvent Evaporation Technique
6.3.4 Atomization and Reconstitution Technique
6.4 Acoustic Nature of Microbubble
6.4.1 Response Under Low Frequency
6.4.2 Response Under High Frequency
6.5 Characterizations of Microbubbles. 6.5.1 Determination of Bubble Size
6.5.2 Determination of Bubble Densities
6.5.3 In Vitro Floating Properties
6.5.4 Microscope Observation and Diameter Measurement
6.5.5 MB Diameter Measurement
6.5.6 MB Concentration Determination
6.5.7 Acoustic Stability of MBs
6.6 Applications of Microbubbles
6.6.1 Diagnostic Applications of Microbubble
6.6.2 Therapeutic Potential of Microbubbles
6.7 Conclusions and Future Prospective
References
7. Virosomes: A Viral Envelope System Having a Promising Application in Vaccination and Drug Delivery System
List of Abbreviations
7.1 Introduction
7.2 What are Virosomes?
7.3 Comparison of Virosomes With Liposomes
7.4 Methods of Preparation of Virosomes. 7.4.1 Selection of Virus
7.4.2 Selection of Compound of Interest (Antigen/Drug/Macromolecule)
7.4.3 Membrane Reconstitution
7.5 Characterization of Virosomes
7.6 Applications of Virosomal Technology
7.6.1 Virosomes for Vaccination
7.6.1.1 Virosomes for Antigen Delivery
7.6.1.2 Virosomes as Adjuvants in Human Vaccine Formulations
7.6.1.3 Virosomes Complexed With Adjuvants
7.6.1.4 Some Commercial Virosome-Based Vaccines. 7.6.1.4.1 Epaxal®
7.6.1.4.2 Inflexal®V Berna
7.6.2 Virosomes for Drug Delivery
7.6.3 Virosomes for Cancer Immunotherapy
7.7 Conclusion
References
8. Nanocarriers: A Tool for Effective Gene Delivery
List of Abbreviations
8.1 Introduction
8.2 Key Steps in Gene Delivery
8.3 Success and Existing Challenges for Gene Delivery
8.4 In Vitro and In Vivo Barriers Towards Successful Gene Transfer
8.5 Genetic Material That can be Delivered in Gene Therapy
8.6 Role of Nanocarriers in a Nucleic Acid Delivery
8.7 Nanocarriers used for Delivering Gene. 8.7.1 Polymeric Nanocarriers
8.7.2 Lipid Nanocarriers
8.7.3 Protein Nanocarriers for Gene Delivery
8.7.4 Magnetic Nanocarriers
8.7.5 Gold Nanocarrier
8.7.6 Quantum Dots
8.7.7 Dendrimers
8.7.8 Stimuli Responsive Nanocarriers
8.7.9 pH Sensitive Liposomes
8.7.10 Temperature Responsive Nanocarriers
8.7.11 Redox Sensitive Nanocarriers
8.8 Cellular Uptake of Nanocarriers and Their Fate Inside the Cell
8.8.1 Cellular Uptake and Intracellular Trafficking of NPs
8.9 Physicochemical Properties of Nanoparticles Affecting Their Uptake
8.10 Targeted Delivery of Genes Using Nanocarriers
8.11 Virosomes
8.12 Exosomes
8.13 Diseases Cured by Gene Therapy
8.14 Clinical Trials
8.15 Current Trends and Approved Products
8.16 Concluding Remarks
References
9. Phytosomes—Nanoarchitectures’ Promising Clinical Applications and Therapeutics
List of Abbreviations
9.1 Introduction
9.1.1 Phytosomes
9.2 Structure of Phytosomes
9.3 Components of Phytosomes
9.3.1 Phyto-Active Ingredients
9.3.2 Phospholipids
9.3.3 Stoichiometric Ratio of Phospholipids and Active Phyto-Constituents
9.3.4 Solvents
9.4 Synthesis of Phytosomes. 9.4.1 Methods
9.5 Characterization of Phytosomes. 9.5.1 Morphological Visualization
9.5.2 Stability of Vesicles
9.5.3 Zeta Potential and Vesicle Size
9.5.4 Transition Temperature
9.5.5 Surface Tension
9.5.6 Entrapment Efficiency
9.5.7 Partition Co-Efficient and Solubility
9.5.8 Spectroscopic Approaches
9.5.8.1 Fourier Transform Infrared Spectroscopy (FTIR)
9.5.8.2 Nuclear Magnetic Resonance (NMR)
9.6 Absorption Mechanism of Phytosomes
9.7 Applications of Phytosomes
9.7.1 Phytosomes in Cancer Therapy
9.7.2 Phytosomes in Diabetes
9.7.3 Phytosomes in Brain Delivery
9.7.4 Phytosomes in Wound Healing
9.7.5 Phytosomes in Liver Diseases
9.8 Recent Trends and Advancements in Phytosomal Delivery
9.9 Future Perspectives
9.10 Conclusion
References
10. Saponin Stabilized Emulsion as Sustainable Drug Delivery System: Current Status and Future Prospects
List of Abbreviations
10.1 Introduction
10.2 Saponins as Surfactant
10.2.1 Quillaja saponaria
10.2.2 Sapindus mukorossi
10.2.3 Glycyrrhiza glabra
10.2.4 Panax ginseng
10.2.5 Tea Saponins
10.2.6 Aesculus hippocastanum
10.2.7 Yucca schidigera
10.2.8 Verbascum nigrum
10.2.9 Saponaria officinalis
10.3 Pharmaceutical Advantages
10.4 Conclusion and Future Prospects
References
11. Mono and Multi-Stimuli Responsive Polymers: Application as Intelligent Nano-Drug Delivery Systems
List of Abbreviations
11.1 Introduction
11.2 Smart or Stimuli-Responsive Polymers for Drug Delivery
11.2.1 Mono-Stimuli Responsive Polymers
11.2.2 Dual-Stimuli Responsive Polymers
11.2.3 Multi-Responsive Polymers
11.2.4 pH Responsive Polymers and Delivery Systems
11.2.5 Temperature Responsive Polymers in Drug Delivery
11.2.6 Light Responsive Drug Delivery Systems
11.2.7 Magnetically Responsive Polymeric Drug Delivery Systems
11.2.7.1 Static (Constant) Field Systems
11.2.7.2 Varying Magnet Field Systems (VMFS)
11.2.8 Other Stimuli Responsive Polymeric Nanoparticles
11.3 Dual and Multi-Stimuli Responsive Drug Delivery Systems
11.4 Conclusion
References
12. An Insight into Nanosomes: Potential Nanopharmaceutical Delivery System
List of Abbreviations
12.1 Introduction
12.2 General Methods of Preparation of Nanosomes and Drug Loading
12.3 Trafficking Mechanism in the Body
12.4 Sterilization of Nanosomes
12.5 Evaluation Parameters. 12.5.1 Determination of Particle Size
12.5.2 Determination of Zeta Potential
12.5.3 Morphological Study
12.5.4 In Vitro Release Studies
12.5.5 Determination of Encapsulation Efficiency
12.5.6 Re-Dispersibility
12.5.7 Stability on Storage
12.6 Applications
12.7 Conclusion
References
13. Nano-Structures as Bioelectronics for Controlled Drug Delivery
List of Abbreviations
13.1 Introduction
13.2 Electroactive Biopolymer
13.3 Electrochemical Desorption From Micro and Nanostructures of Conductive Polymers
13.4 Electrochemical Desorption From Micro and Nano-Composites of Conductive Polymers
13.5 Electrochemical Desorption of Self-Assembled Monolayer From a Gold Surface
13.6 Electrochemically Actuated Release of Biochemicals
13.7 Biochemical Release Controlled by Electrochemical Erosion of Electrolyte Hydrogel and Nanofilm
13.8 Biochemical Release by Electrochemical and Electrothermal Erosion of Metallic Sealing Membranes
13.9 Release of Biochemicals by Fluidic Nano-Pumps and Rotating Nano-Motors Powered by Electric Fields
13.9.1 Electro-Osmotic Nano-Pumps
13.9.2 Nanowires
13.9.3 Electrically Driven Nanomotors
13.10 Conclusion and Future Aspects
References
14. Bioadhesive Nanoparticulate Drug Delivery System
List of Abbrevations
14.1 Introduction
14.2 Mucous Membrane
14.3 Mucoadhesive Forces
14.4 Theories of Mucoadhesion
14.4.1 Electronic Theory
14.4.2 Adsorption Theory
14.4.3 Wetting Theory
14.4.4 Diffusion Theory
14.5 Mechanism of Mucoadhesion
14.6 Polymers Used to Prepare Mucoadhesive Nanoparticles
14.7 Ideal Properties of Mucoadhesive Polymers
14.8 Mucoadhesion of Nanoparticles
14.9 Preparation Methods of Mucoadhesive Polymeric Nanoparticles. 14.9.1 Solvent Displacement Method
14.9.2 Surface Modification of Nanoparticles With Mucoadhesive Polymers
14.9.3 Emulsion Polymerization
14.10 Evaluation of Mucoadhesive Systems
14.10.1 In Vitro and Ex Vivo Tests
14.10.2 Measurement of Tensile Strength
14.10.3 Measurement of Detachment Force
14.10.4 Falling Liquid Film Method
14.10.5 Colloidal Gold Staining Method
14.10.6 Biacore System
14.10.7 Confocal Laser Scanning Microscopic (CLSM) Method
14.10.8 In Vivo Methods. 14.10.8.1 Gamma Scintigraphy
14.10.8.2 X-Ray (GI Transit Time) Studies
14.10.8.3 Isolated Loop Technique
14.11 Evaluation Tests of Mucoadhesive Nanoparticulate Systems
14.11.1 Adhesion Test
14.11.2 Atomic Force Microscopy
14.11.3 Fluorophotometric Evaluation
14.12 Applications
14.13 Conclusion
References
15. Nanopharmaceuticals: An Approach for Effective Management of Breast Cancer
List of Abbreviations
15.1 Introduction
15.2 Stages of Breast Cancer
15.3 Main Types of Breast Cancer
15.4 Drawbacks in Conventional Treatment
15.5 Nanoparticulate Approach for Effective Management of Breast Cancer
15.6 Systematic Drug Delivery System Approaches
15.6.1 Metallic Nanodrug Carrier. 15.6.1.1 Magnetic Nanoparticles
15.6.1.2 Gold Nanoparticles
15.6.1.3 Superparamagnetic Iron Oxide (SPIO)
15.6.2 Polymer-Based Drug Carriers
15.6.2.1 Polymeric Nanoparticles
15.6.2.2 Polymeric Micelles
15.6.2.3 Dendrimers
15.6.3 Drug Carriers Based on Lipid. 15.6.3.1 Liposomes
15.6.4 Viral Nanoparticles
15.6.5 Carbon Nanotubes
15.7 Nanoparticles Targeted Drug Delivery
15.7.1 Morphology of Nanoparticles
15.7.1.1 Size
15.7.1.2 Surface Characteristics
15.7.2 Passive Targeting. 15.7.2.1 Increase Permeability and Retention Time
15.7.2.2 Tumor Physiology
15.7.3 Active Targeting
15.7.3.1 Antigen or Receptor Expression
15.7.3.2 Internalization of Targeted Conjugates
15.8 Various Ligands used for Targeting Cancer Cells. 15.8.1 Folate
15.8.2 Aptamer
15.8.3 Transferrin
15.8.4 Lectins
15.8.5 Reverselectin
15.8.6 Epidermal Growth Factor Receptor (EGFR)
15.8.7 Quantum Dots (QD)
15.8.8 Si RNA
15.9 New Innovative Pharmaceutical Entities and Targeting Moieties
15.10 Future of Cancer Treatment in Nanotechnology
15.11 Conclusion
References
16. Vaginal Nano-Based Drug Delivery System
List of Abbreviation
16.1 Introduction
16.2 Vaginal Anatomy Physiology and Diseases of Vagina. 16.2.1 Physiology of Vagina
16.2.2 Vaginal Infections
16.3 Advantages of Vaginal Drug Delivery
16.4 Drawbacks of Conventional Vaginal Formulation
16.5 Need of Nanocarriers for Vaginal Delivery
16.6 Different Types of Nanoparticles for Vaginal Therapy
16.6.1 Concept of pH-Sensitive Nanoparticles
16.6.2 Acid-Labile Products (Nucleic Materials/Proteins/Peptides)
16.6.3 Mucoadhesive Nanoparticles
16.6.4 Mucous-Penetrating Nanoparticles
16.6.5 PEGylated Nanoparticles
16.6.6 Dendrimers
16.6.7 Liposomes
16.6.8 Niosomes
16.6.9 Nanoemulsion
16.6.10 Metallic Nanoparticles
16.6.11 Diagnostic Nanoparticles
16.7 Vaginal Patents
16.8 Nanotoxicity: Future Prospective
16.9 Conclusion
References
17. Recent Advances in Polymer-Modified Liposomes for Cancer Treatment
List of Abbreviations
17.1 Introduction
17.2 Liposomes
17.2.1 Structure of Liposomes
17.2.2 Classification of Liposomes
17.2.3 Preparation of Liposomes
17.2.4 Drug Encapsulation Into Liposomes
17.2.4.1 Active Loading of a Drug Into Liposome
17.2.4.2 Passive Loading of a Drug Into Liposome
17.2.5 Mechanism of Liposomes
17.2.6 Liposomes in Cancer Treatment
17.2.7 Liposomal Formulations Available in Clinical Trials for Cancer Treatment
17.2.8 Liposomes Targeting Cancerous Cells
17.2.8.1 Liposome Mediated Active Targeting of Cancer Cells
17.2.8.2 Liposome Mediated Passive Targeting of Cancer Cells
17.2.9 Strategies for Targeting Liposomes at Cancer Specific Site
17.2.9.1 Increased Permeability & Retention (EPR) Effect and their Application in Cancer Treatment
17.2.9.2 Surface Engineered Liposomes Mediated Active Targeting with Functionalized Targeting Ligands
17.2.10 Approaches for Enhanced Delivery of Chemotherapeutic Drugs at Tissue Specific Site via Functionalized Liposomes Responsive Towards Stimuli
17.2.10.1 Liposomes Responsive to Temperature
17.2.10.2 Liposomes Responsive to pH
17.2.10.3 Liposomes Responsive to Magnetic Field
17.2.10.4 Liposomes Responsive to Ultrasound
17.2.11 Role of Polymers in Drug Delivery for the Treatment of Cancer
17.3 Future Challenges Associated With Cancer Therapy
17.4 Conclusion
References
18. Role of Nanomedicines in Neglected Tropical Diseases
List of Abbreviations
18.1 Introduction
18.2 Diseases. 18.2.1 Buruli Ulcer
18.2.1.1 Current Therapeutics for Buruli Ulcer
18.2.1.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Buruli Ulcer
18.2.2 Chagas Disease
18.2.2.1 Current Treatment for Chagas Disease
18.2.2.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Chagas Disease
18.2.3 Cysticercosis
18.2.3.1 Current Treatment for Cysticercosis
18.2.3.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Cysticercosis
18.2.4 Dengue Fever
18.2.4.1 Current Treatment for Dengue Fever
18.2.4.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Dengue Fever
18.2.5 Dracunculosis
18.2.5.1 Current Treatment for Dracunculosis
18.2.5.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Dracunculosis
18.2.6 Echinococcosis
18.2.6.1 Current Treatment for Echinococcosis
18.2.6.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Echinococcosis
18.2.7 Fascioliasis
18.2.7.1 Current Treatment for Fascioliasis
18.2.7.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Fascioliasis
18.2.8 Foodborne Trematodes
18.2.8.1 Current Treatment for Foodborne Trematodes
18.2.8.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Foodborne Trematodes
18.2.9 Human African Trypanosomiasis
18.2.9.1 Current Treatment for Human African Trypanosomiasis
18.2.9.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Human African Trypanosomiasis
18.2.10 Leishmaniasis
18.2.10.1 Current Treatment for Leishmaniasis
18.2.10.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Leishmaniasis
18.2.11 Leprosy
18.2.11.1 Current Treatment for Leprosy
18.2.11.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Leprosy
18.2.12 Lymphatic Filariasis
18.2.12.1 Current Treatment for Lymphatic Filariasis
18.2.12.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Lymphatic Filariasis
18.2.13 Mycetoma, Chromoblastomycosis and Other Deep Mycoses
18.2.13.1 Current Treatment for Mycetoma, Chromoblastomycosis and Other Deep Mycoses
18.2.13.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Mycetoma, Chromoblastomycosis and Other Deep Mycoses
18.2.14 Onchocerciasis
18.2.14.1 Current Treatment for Onchocerciasis
18.2.14.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Onchocerciasis
18.2.15 Rabies
18.2.15.1 Current Treatment for Rabies
18.2.15.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Rabies
18.2.16 Schistosomiasis
18.2.16.1 Current Treatment for Schistosomiasis
18.2.16.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Schistosomiasis
18.2.17 Snakebite Envenoming
18.2.18 Soil-Transmitted Helminthiases
18.2.18.1 Treatment for Soil-Transmitted Helminthiases
18.2.18.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Soil-Transmitted Helminthiases
18.2.19 Trachoma
18.2.19.1 Treatment for Trachoma
18.2.19.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Trachoma
18.2.20 Yaws
18.2.20.1 Treatment for Yaws
18.2.20.2 Issues in Prevailing Therapy and Status of Nanomedicine in Treatment of Yaws
18.3 Conclusion
Acknowledgement
References
19. Current Framework, Ethical Consideration and Future Challenges of Regulatory Approach for Nano-Based Products
List of Abbreviations
19.1 Introduction
19.2 Issues in Aspect of Regulation of Drug Delivery System. 19.2.1 Environmental, Health and Safety Risks
19.2.2 Ethical, Legal and Social Issues
19.3 Regulation of Nano-Based Products in Global Realms of the World
19.3.1 United States
19.3.1.1 Agency of US Environmental Protection
19.3.1.2 United States of Food and Drug Administration
19.3.2 United Kingdom
19.3.3 European Union (EU)
19.3.3.1 Progress of Regulatory Measures in European Union
19.3.4 Australia
19.3.5 Canada
19.3.6 Other Countries
19.4 Regulatory Challenges and Solutions in DDS Development
19.4.1 Classification
19.4.2 Chemistry, Manufacturing and Control
19.4.3 Non-Clinical Safety
19.4.4 Clinical Studies and Post Marketing Surveillance
19.5 Regulatory Education and its Involvement in Pharmaceutical Industry for the Development of Novel Drug Delivery Systems
19.6 Current Framework and Future Challenges
19.7 Conclusion
References
Index
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