Nanotechnology in Medicine: Toxicity and Safety

ISBN-13: 9781119769866 / Angielski / Twarda / 2021 / 448 str.

Mahendra Rai; Mrunali Patel; Rashmin Patel

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Preface xiiiList of Contributors xvList of Abbreviations xixPart I Nanomedicine: Nanotoxicological Insights 11 Nanomedicines: Applications and Toxicological Concerns 3Mrunali Patel, Rashmin Patel, and Mahendra Rai1.1 Introduction 31.2 Nanomedicine's Revolution 91.3 Potential Applications of Nanomedicine 101.3.1 Diagnosis 101.3.2 Drug Delivery 121.3.3 Tissue Engineering and Regenerative Medicine 171.4 Clinical Translation of Nanomedicine 181.5 Nanotoxicological Challenges 191.6 Safety Issues and Regulations 221.7 Conclusion and Future Perspectives 23References 242 Microbial Biopolymers and Their Derivatives as Nanotechnological Tools for Medicine:Applications, Advantages, Toxicity, and Safety 29Paulo Ricardo Franco Marcelino, Fernanda Gonçalves, Nayelen Sayuri Aizawa, Henrique PaivaPereira, Talita Martins Lacerda, and Silvio Silvério da Silva2.1 Introduction 292.2 Natural Polymers: Conceptualization, Classifications, and Physicochemical Characteristics 302.3 Applications of Biopolymers in Nanoparticles, Nanofibers, and Drug Delivery Systems of Therapeutic Importance 352.4 Safety of Microbial Biopolymers Used in Nanoscale-Systems for Therapeutic Applications 382.5 Conclusions 40References 41Part II Nanoparticles: Toxicity and Safety 473 Selenium Nanoparticles: Toxicity and Safety 49Irina A. Shurygina, Irina S. Trukhan, Nataliya N. Dremina, and Michael G. Shurygin3.1 Introduction 493.2 Selenium Forms 503.3 Toxicity of Selenium Nanoparticles 523.4 Toxicity Mechanisms 563.5 Conclusion 60References 604 Impact of Nanoparticles on Protozoa 67Daniela Plachá and Josef Jampílek4.1 Introduction 674.1.1 Antiprotozoal Drugs 724.2 Nanosystems 744.2.1 Preparation and Synthesis of Nanoparticles and Systems 754.3 Nanosystems with Effect on Human Parasitic Protozoa 774.3.1 Malaria 774.3.2 Trypanosomiases 794.3.3 Leishmaniasis 814.3.4 Toxoplasmosis 874.3.5 Cryptosporidium 894.3.6 Acanthamoeba 904.4 Nanosystems with Effect on Veterinary Parasitic Protozoa 914.5 Nanomaterial Toxicity on Beneficial Protozoa 934.6 Conclusion 96Acknowledgment 97References 975 Toxicity of Metallic Nanoparticles: A Pressing Issue 109Tejal Mehta, Dhaivat Parikh, Kartik Hariharan, Namdev Dhas, and Viral Patel5.1 Introduction 1095.2 Toxicity of Metal Nanoparticles and Influence of Physicochemical Properties 1105.2.1 Toxicity of Copper and Copper Oxide Nanoparticles 1105.2.2 Toxicity of Gold Nanoparticles 1125.2.2.1 Physicochemical Factors Influencing AuNPs' Toxicity 1125.2.3 Toxicity of Silver Nanoparticles 1155.2.4 Toxicity of Zinc Oxide Nanoparticles 1175.2.5 Toxicity of Iron Oxide Nanoparticles 1185.2.6 Physicochemical Properties Affecting Toxicity 1195.3 Accumulation and Toxicity of Metal-Based Nanoparticles in Various Organs 1195.4 Conclusion and Future Perspectives 128Acknowledgment 128References 1286 Toxicity, Safety, and Biodistribution of Multifunctional Mesoporous SilicaNanoparticles 137Mansi Athalye, Rashmin Patel, and Mrunali Patel6.1 Introduction 1376.2 Bioapplicability of Mesoporous Silica Nanoparticles 1386.3 Biodistribution, Toxicity, and Safety of MSN 1396.3.1 Factors Affecting Biodistribution of Mesoporous Silica Nanoparticles 1406.3.1.1 Particle Size 1406.3.1.2 Particle Shape 1426.3.1.3 Functionalization 1426.3.1.4 Dose 1446.3.1.5 Route of Administration 1456.4 Safety Evaluation of Mesoporous Silica Nanoparticles 1456.4.1 Cytotoxicity 1466.4.2 Tissue Compatibility 1476.4.3 Genotoxicity 1476.4.4 Immunotoxicity 1486.4.5 Autophagy 1486.4.6 Endothelial Dysfunction and Toxic Effects on Blood Cells 1496.4.7 Blood Compatibility 1496.4.8 Neurotoxicity 1496.5 Conclusion and Future Directions 149References 1537 Safety and Toxicity Issues of Polymeric Nanoparticles: A Serious Concern 156Priya Patel, Naimish Vyas, and Mihir Raval7.1 Introduction 1567.2 Application of Nanomaterials 1577.3 Classification of Nanoparticles (NPs) 1577.3.1 Polymeric Nanoparticles 1587.3.1.1 Advantages of Polymeric Nanoparticles 1597.3.1.2 Polymers Used in the Preparation of Polymeric Nanoparticles 1597.3.1.3 Methods of Preparation of Polymeric Nanoparticles 1607.3.1.4 Polymeric Nanoparticles in Drug Delivery 1627.4 Nanotoxicology 1637.4.1 Toxicity of Nanoparticles 1637.4.2 Tissue Toxicity of Nanomedicine 1647.4.3 Mechanisms of Nanoparticle Toxicity 1647.4.4 Toxicity of Polymeric Nanoparticles 1647.4.5 Nanoformulations Showing Toxicity 1657.5 Safety Assessment of Nanomedicines by Methodological Considerations 1677.5.1 Nanoparticles Safety Study 1687.5.2 Methodological Considerations for Safety Assessment of Nanomedicines 1697.6 Conclusion and Future Perspectives 170References 1708 Green Synthesis of Copper and Copper-Based Nanoparticles for Their Use in Medicine: Toxicity and Safety 174Sadhucharan Mallick and Piyali Sabui8.1 Introduction 1748.2 Green Synthesis Methods of Copper and Copper-Based Nanoparticles 1768.2.1 Fungi-Assisted Synthesis of Nanoparticles 1768.2.2 Actinomycetes-Assisted Synthesis of Nanoparticles 1768.2.3 Bacteria-Assisted Synthesis of Nanoparticles 1778.2.4 Algae-Assisted Synthesis of Nanoparticles 1778.2.5 Phytochemical-Assisted Synthesis of Nanoparticles 1778.2.6 Biomolecule and Biopolymer-Mediated Synthesis of Nanoparticles 1788.3 Purification of Copper and Copper-Based Nanoparticles 1798.4 Characterization of Green Synthesized Copper and Copper-Based Nanoparticles 1798.5 Copper and Copper-Based Nanoparticles as Nanomedicines 1798.5.1 Application as Antibacterial Agents 1798.5.2 Application as Antifungal Agents 1828.5.3 Application as Antiviral Agents 1828.5.4 Application as a Targeted Drug Delivery System 1828.5.5 Application as Anticancer Agents 1838.5.6 Applications in Molecular Imaging 1848.6 Copper and Copper-Based Nanoparticles and Their Toxicity 1848.6.1 Nanotoxicology 1848.6.2 Different Types of Toxicity 1858.6.3 Toxicity Effect of Copper and Copper-Based Nanoparticles 1858.7 Safety Implications of Copper and Copper-Based Nanoparticles 1868.8 Future Perspectives 1878.9 Conclusion 188References 189Part III Nanotoxicology and Drug Delivery 1959 Gene Delivery Using Nanocarriers: Toxicity and Safety Aspects 197Imran Vhora and Nirav Khatri9.1 Introduction 1979.2 Nanocarrier Types 1989.2.1 Lipid-Based Nanocarriers 1989.2.2 Polymeric Nanocarriers 2009.3 Target Diseases and Routes of Administration 2009.4 Learnings from Clinical Trials 2149.4.1 Toxicity with Systemic Delivery - Intravenous Administration 2159.4.2 Toxicity with Local Delivery 2159.4.2.1 Pulmonary Delivery 2169.4.2.2 Intratumoral and Other Local Delivery in Cancer 2169.4.2.3 Subcutaneous, Intradermal, and Intramuscular Delivery 2169.5 Mechanisms of Toxicity of Gene Delivery Nanocarriers 2179.5.1 Cellular Damage and Inflammatory Mediators 2179.5.2 ROS Induction 2199.5.2.1 Off-target Effects of the Genetic Cargo 2199.6 Overcoming Toxicity Issues with Nanocarrier-Mediated Gene Therapy 2209.6.1 Modification of Genetic Cargoes 2209.6.2 Modification of Nanocarrier System 2209.6.2.1 Optimizing Excipient Chemistry - Lipid and Polymer Chemistry 2209.6.2.2 Modification of Nanocarrier Morphology 2229.6.3 Preclinical Testing for Expected Toxicities 2239.7 Future Perspectives and Conclusion 225References 22610 Toxicity and Safety Evaluation of Lipid-Based Nanoparticles for Brain Delivery 233Mitali Patel and Priyanshi Patel10.1 Introduction 23310.2 Barriers Across Brain Delivery 23410.2.1 The Blood-Brain Barrier (BBB) 23410.2.2 The Blood Cerebrospinal Fluid (BCSF) Barrier 23410.3 Role of Lipid Nanoparticles in Brain Delivery 23510.3.1 Liposomes 23610.3.2 Solid Lipid Nanoparticles (SLNs) 23610.3.3 Nanostructured Lipid Carriers (NLCs) 23710.3.4 Lipid-Drug Conjugates (LDCs) 23710.3.5 Lipid Polymer Hybrid Nanoparticles (LPHNPs) 23810.4 Transport Mechanisms Involved for Brain Delivery 23810.4.1 Paracellular Transport 23810.4.2 Transcellular Transport 23810.4.3 Carrier-mediated Transport 23810.4.4 Receptor-mediated Endocytosis 23810.4.5 Adsorptive-mediated Endocytosis 23910.5 Toxicity of Lipid Nanoparticles 23910.6 Safety of Lipid Nanoparticles 24010.7 Conclusion and Future Perspectives 242References 24211 Risk Assessment of Injectable Nanoparticles Used as Nanomedicine 248Marco Vinícius Chaud, Fernando Batain, Eliana Barbosa Souto, Patrícia Severino, AleksandraZieliDska, and Thais Francine Ribeiro Alves11.1 Introduction 24811.2 Nanomaterials, Nanoparticles, and Nanoformulation 24911.3 Injectable Nanoparticles Toxicity 25111.4 Safety of Nanoparticles in Acute and Chronic Studies 25311.5 Future Perspectives and Conclusion 254References 25512 Dermatological Delivery of Nanodrugs: Applications, Toxicity, and Safety 259Saurabh Shivalkar, Arushi Verma, Vishal Singh, and Amaresh Kumar Sahoo12.1 Introduction 25912.2 An Overview of Dermatology and Nanodrugs 26012.3 Nanomaterials for Dermatologically Active Nanodrugs 26212.4 Nanoformulations for Topical and Transdermal Delivery 26512.5 Applications of Dermatological Nanodrugs and Its Delivery Mechanisms 26812.5.1 Prevention 26812.5.1.1 Antisepsis 26812.5.1.2 Cosmetics and Photoprotection 26912.5.2 Diagnosis 26912.5.3 Therapeutic Applications 27012.5.3.1 Phototherapy 27012.5.3.2 Sebaceous Gland Disorders 27012.5.3.3 Treatment of Inflammatory Skin Diseases 27012.5.3.4 Other Therapeutic Applications 27012.6 Toxicity Evaluation of Dermatologically Active Nanodrugs 27112.6.1 Nanodrugs and Toxicity Due to Penetration 27112.6.2 Genotoxicity 27312.7 Safety Considerations 27312.8 Limitations and Risk 27412.9 Conclusion 274References 27513 Nanonutraceuticals: Considerations for Toxicity and Safety Assessment 281Shah Esha Bhavin and Anuradha Ketan Gajjar13.1 Introduction 28113.2 Novel Carrier-Based Drug Delivery Systems 28213.2.1 Lipidic Nanosystems 28313.2.1.1 Non-Vesicular Systems 28313.2.1.2 Vesicular Systems 28313.2.2 Polymeric Nanosystems 28313.2.3 Lipid Polymer Nanosystems 28513.3 Safety and Toxicity Assessment of Nanoparticles 28513.4 Approaches for Biodegradable Nanoparticles 28913.5 Modified Nanocarriers (Nanosponges) 29113.5.1 Cyclodextrin-Based Nanosponges 29113.6 Conclusion and Future Perspectives 293References 29314 Current Challenges and Future Needs for Nanotoxicity and Nanosafety Assessment 299Ravish J. Patel, Amit Alexander, Anu Puri, and Bappaditya Chatterjee14.1 Introduction 29914.2 Nanomaterials: Risk Assessment 30214.3 The Hurdles in Toxicity Evaluation of Nanomaterials 30414.3.1 Physicochemical Properties of Nanomaterials' Characterization 30414.3.1.1 Size of Nanomaterials 30414.3.1.2 Composition Effects 30414.3.1.3 Surface-Related Effects 304 Agglomeration 30514.3.1.5 Solubility 30514.3.1.6 Surface Charge and Dispersity 30514.3.1.7 Dose Metric 30514.3.2 In vitro, In vivo, and In silico Approaches for the Assessment of Toxicity for the Nanomaterials 30514.4 Nanosafety Assessment Tools 30714.5 Conclusion and Perspectives 308References 310Part IV Nanotechnology, Ethics, and Regulatory Framework 31515 Safety Regulations for the Use of Nanotechnological Products for Biomedical Applications: A Systematic Literature Review 317Raquel Von Hohendorff, Wilson Engelmann, and Daniele Weber S. Leal15.1 Introduction 31715.2 The State-of-the-art of Biomedical Applications of Nano-Products 31815.3 The Scientific Perspective on Nano-products for Biomedical Applications, Risks, and Regulations 32215.4 Using RRI as a Methodological Pathway Toward Communication Between the Science System and the Law System 32415.5 Final Considerations and New Propositions 340Notes 341References 34216 Nanoethics and Nanotechnology 349Iti Chauhan, Madhu Verma, and Mohd Yasir16.1 Introduction 34916.1.1 Types of Nanotechnology 34916.1.2 Applications of Nanotechnology 34916.2 Nanoethics 35116.2.1 Regulatory Agencies 35416.2.1.1 Nanotechnology and State Regulation (India) 35516.2.2 Distributive Justice 35616.2.2.1 Bridging the Gap 35716.2.3 Nanoweapons 35816.2.4 Ethics in Nanomedicine 35816.2.4.1 Ethics in Research and Development 35916.2.4.2 Health and Safety Issues 36016.2.4.3 Toxicity Associated with Nanoparticulate System 36116.2.5 Privacy and Confidentiality 36116.2.6 Human Enhancement 36216.2.7 Nanopollution 36316.2.7.1 Health Issues 36316.2.7.2 Measuring Nanomaterials' Concentration in the Environment 36416.2.7.3 Environmental Issues 36516.2.7.4 Social Issues 36516.2.7.5 Speculative Issue 36616.2.8 Educational Issues 36716.2.9 Biological Issues 36716.3 Conclusion 368References 36817 Current Regulatory Framework in Nanotechnology and Medicine 373Nitin Dubey and Nidhi Dubey17.1 Introduction 37317.1.1 Classification of Nanomaterials 37417.1.2 Nanoparticles 37417.2 Quality Attributes and Regulatory Concerns of Nanomaterials 37517.2.1 Physicochemical Characterization 37517.2.2 Nonclinical Studies for Nanomaterials 37617.2.3 Clinical Studies for Nanomaterials 37717.2.4 Identification of Hazardous Material 37717.2.5 Exposure Risk to Humans and Environment During Nanomaterial Manufacturing, Storage, or Disposal 37817.3 Quality Assessment of Nanomedicines 38017.4 Current Regulatory Framework over Nanomaterials 38117.4.1 USA 38217.4.1.1 ANSI 38717.4.1.2 ASTM 38717.4.2 European Union 38717.4.2.1 CEN 39017.4.3 Taiwan 39017.4.4 Iran 39017.4.5 Canada 39017.4.6 Australia 39117.4.7 Japan 39217.4.8 India 39217.4.9 People's Republic of China 39317.4.10 Republic of Korea 39417.4.11 Russia 39417.4.12 WHO 39417.4.13 OECD 39417.4.14 ISO 39617.4.15 VAMAS 39717.5 Conclusion and Future Outlook 401References 402Index 407

O autorze

Mahendra Rai, PhD, is Professor in the Department of Biotechnology at Sant Gadge Baba Amravati University, India. Professor Rai has edited more than 60 books and published over 400 research papers and reviews in international peer-reviewed journals.Mrunali Patel, PhD, is Professor at Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa, Gujarat, India. She has written several book chapters and over 100 research papers, reviews, and technical articles. Her research focuses on nanodrug delivery.Rashmin Patel, PhD, is Professor at Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa,Gujarat, India. He has written several book chapters and over 100 research papers, reviews, and technical articles. His research is focused on nanoassessment.