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Pharmaceutical Nanotechnology


Pharmaceutical Nanotechnology

Innovation and Production
Applications of Nanotechnology 1. Aufl.

von: Jean Cornier, Andrew Owen, Arno Kwade, Marcel Van de Voorde

297,99 €

Verlag: Wiley-VCH
Format: PDF
Veröffentl.: 28.11.2016
ISBN/EAN: 9783527800674
Sprache: englisch
Anzahl Seiten: 775

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Beschreibungen

With its focus on concrete methods and recent advances in applying nanotechnology to develop new drug therapies and medical diagnostics, this book provides an overall picture of the field, from the fundamentals of nanopharmacy with the characterisation and manufacturing methods to the role of nanoparticles and substances. Actual examples of utilization include drug development issues, translation to the clinic, market prospects, and industrial commercialization aspects. The applications described are taken from cancer treatment as well as other major therapeutic areas, such as infectious diseases and dermatology. An in-depth discussion on safety, regulatory, and societal aspects rounds off the book.<br> Written by a top team of editors and authors composed of the leading experts in Europe and the USA who have pioneered the field of nanopharmacy!
<p>Foreword XXVII</p> <p>Industrial Requirement on Nanopharmacy Research XXIX</p> <p>Introduction XXXI</p> <p><b>Volume 1</b></p> <p><b>Part One Entry to the Nanopharmacy Revolution 1</b></p> <p><b>1 History: Potential, Challenges, and Future Development in Nanopharmaceutical Research and Industry 3</b><br /><i>Albertina Ariën and Paul Stoffels</i></p> <p>1.1 Nanopharmaceuticals in Cancer Therapy 4</p> <p>1.2 Nanoparticles Actively Using the Host Machinery 5</p> <p>1.3 Nanopharmaceuticals for Oral Administration and Long-Acting Injectable Therapy 8</p> <p>1.4 Bridging Future Nanomedicines to Commercialization 10</p> <p>1.5 Future Outlook 11</p> <p>Acknowledgments 12</p> <p>References 12</p> <p><b>2 Nanoscale Drugs: A Key to Revolutionary Progress in Pharmacy and Healthcare 17</b><br /><i>Simon Sebastian Raesch, Marina Poettler, Christoph Alexiou, and Claus-Michael Lehr</i></p> <p>2.1 Introduction 17</p> <p>2.2 Nanopharmacy Concepts to Improve the Safety and Efficacy of Medicines 20</p> <p>2.3 Technical Realization of Nanopharmaceuticals 30</p> <p>2.4 Safety of Nanopharmaceuticals 34</p> <p>2.5 Present and Future of Nanopharmacy 35</p> <p>References 37</p> <p><b>3 The Emergence of Nanopharmacy: From Biology to Nanotechnology and Drug Molecules to Nanodrugs 43</b><br /><i>Marilena Hadjidemetriou, Zahraa Al-Ahmady, Mariarosa Mazza, and Kostas Kostarelos</i></p> <p>3.1 Introduction 43</p> <p>3.2 First Generation of Nanopharmaceuticals: From Drug Molecules to Nanodrugs 45</p> <p>3.3 Conclusion 55</p> <p>References 56</p> <p><b>4 Understanding and Characterizing Functional Properties of Nanoparticles 63</b><br /><i>Ester Polo, Valentina Castagnola, and Kenneth A. Dawson</i></p> <p>4.1 Introduction 63</p> <p>4.2 The Approach to Characterization 70</p> <p>References 77</p> <p><b>5 Omics-Based Nanopharmacy: Powerful Tools Toward Precision Medicine 81</b><br /><i>Daniel Rosenblum and Dan Peer</i></p> <p>5.1 Introduction 81</p> <p>5.2 Precision Medicine 82</p> <p>5.3 “OMICS” – New Era in Understanding Pathology 86</p> <p>5.4 Nanomedicine 90</p> <p>5.5 Future Outlook 93</p> <p>Acknowledgments 96</p> <p>References 96</p> <p><b>Part Two Fundamentals of Nanotechnology in Pharmacy 101</b></p> <p><b>6 Nanostructures in Drug Delivery 103</b><br /><i>Salma Nabil Tammam and Alf Lamprecht</i></p> <p>6.1 Introduction 103</p> <p>6.2 Nanocarrier Classification 103</p> <p>6.2.1 Inorganic Nanostructures 104</p> <p>6.3 Drug Loading and Release 116</p> <p>6.4 General Discussion and Conclusions 123</p> <p>References 124</p> <p><b>7 Characterization Methods: Physical and Chemical Characterization Techniques 135</b><br /><i>Sven Even F. Borgos</i></p> <p>7.1 The Need for Nanomedicine-Specific Characterization 135</p> <p>7.2 The Assay Cascade: From Basic Properties to Complex Interactions 136</p> <p>7.3 Physicochemical Characterization of Pristine Nanoparticles 137</p> <p>7.4 Characterization of Nanoparticles in the Biological Environment 144</p> <p>7.5 Conclusions and Future Outlook 149</p> <p>References 150</p> <p><b>8 Nanoparticle Characterization Methods: Applications of Synchrotron and Neutron Radiation 157</b><br /><i>Martha Brennich, Marité Cardenas, Hiram Castillo-Michel, Marine Cotte, V. Trevor Forsyth, Michael Haertlein, Simon A. J. Kimber, Geraldine Le Duc, Edward P. Mitchell, Adam Round, Murielle Salome, and Michael Sztucki</i></p> <p>8.1 Advanced Characterization: Synchrotron Light and Neutron Sources 157</p> <p>8.2 Application Examples 159</p> <p>8.3 Going Beyond Characterization Using Synchrotron X-rays: Nanoparticles for Diagnostic and Therapeutic pproaches 168</p> <p>8.4 Looking Ahead and Conclusions 169</p> <p>Acknowledgments 170</p> <p>References 171</p> <p><b>9 Overview of Techniques and Description of Established Processes 175</b><br /><i>Jan Henrik Finke, Michael Juhnke, Arno Kwade, and Heike Bunjes</i></p> <p>9.1 Introduction 175</p> <p>9.2 Processing of Liquid Drug Carrier Formulations 176</p> <p>9.3 Drug Nanoparticles and Process Chains to Solid Formulations 192</p> <p>9.4 Industrial Status and Framework 215</p> <p>9.5 Perspectives for Academia, Industry, and Regulatory Authorities 216</p> <p>References 217</p> <p><b>10 Nanopharmacy: Exploratory Methods for Polymeric Materials 231</b><br /><i>Kuldeep Bansal, Luana Sasso, Hiteshri Makwana, Sahar Awwad, Steve Brocchini, and Cameron Alexander</i></p> <p>10.1 Introduction 231</p> <p>10.2 Rationale for the Use of Polymers in Nanomedicines 232</p> <p>10.3 Polymer Structures and Properties 234</p> <p>10.4 Formulation of Copolymers into Micelles, Vesicles, and Nanoparticles 236</p> <p>10.5 Conjugation of Polymers to Drugs and Proteins 240</p> <p>10.6 Recent Advances in Polymer Synthesis for Therapeutic Applications 248</p> <p>10.7 Controlled Radical Polymerization (CRP) 259</p> <p>10.8 Concluding Remarks 260</p> <p>References 261</p> <p><b>11 Overview and Presentation of Exploratory Methods for Manufacturing Nanoparticles/“Inorganic Materials” 271</b><br /><i>Xavier Le Guevel</i></p> <p>11.1 Introduction 271</p> <p>11.2 Gold NPs 272</p> <p>11.3 Magnetic NPs 279</p> <p>11.4 Metal Oxide NPs 282</p> <p>11.5 Others (Silver, Quantum Dots, and Lanthanides) 284</p> <p>11.6 Conclusion and Perspective 285</p> <p>Acknowledgment 285</p> <p>References 285</p> <p><b>12 Scale-Up and cGMP Manufacturing of Nanodrug Delivery Systems for Clinical Investigations 295</b><br /><i>Mostafa Nakach and Jean-René Authelin</i></p> <p>12.1 Introduction 295</p> <p>12.2 Presentation of Major Manufacturing Processes of Different Nanodrug Delivery Systems 296</p> <p>12.3 Nanodrug Delivery Systems as Marketed Products 302</p> <p>12.4 Particle/Vesicle Size Reduction Technologies 302</p> <p>12.5 Process Development and Scale-Down/Scale-Up Strategy 308</p> <p>12.6 Technological Concept for Manufacture of Drug Product for Human Use (GMP Unit) 322</p> <p>12.7 Conclusion 327</p> <p>References 327</p> <p><b>13 Occupational Safety and Health 331</b><br /><i>Thomas H. Brock</i></p> <p>13.1 Nanomaterials at the Workplace 331</p> <p>13.2 Legal Aspects 335</p> <p>13.3 Management of Uncertainty 336</p> <p>13.4 Risks of Nanomaterials for Researchers and Workers 336</p> <p>13.5 Prudent Practices and Proven Concepts for Controlling Risks 338</p> <p>13.6 Instruction and Training 351</p> <p>13.7 Summary 352</p> <p>References 352</p> <p><b>Volume 2</b></p> <p><b>Part Three Development of Nanopharmaceuticals 355</b></p> <p><b>14 Micro- and Nano-Tools in Drug Discovery 357</b><br /><i>Andreas Dietzel, Monika Leester-Schädel, and Stephan Reichl</i></p> <p>14.1 Introduction 357</p> <p>14.2 General Concepts of Miniaturization 357</p> <p>14.3 Micro- and Nanofabrication 359</p> <p>14.4 Nanoformulation 367</p> <p>14.5 Organ-on-a-Chip 372</p> <p>References 375</p> <p><b>15 Computational Predictive Models for Nanomedicine 379</b><br /><i>Marco Siccardi, Alessandro Schipani, and Andrew Owen</i></p> <p>15.1 Introduction 379</p> <p>15.2 Molecular Modeling in Nanomedicine 381</p> <p>15.3 Computational Approaches for Predicting Nanotoxicology 384</p> <p>15.4 Simulation of Nanoparticle Pharmacokinetics 386</p> <p>15.5 Conclusion 395</p> <p>References 397</p> <p><b>16 Drug Targeting in Nanomedicine and Nanopharmacy: A Systems Approach 403</b><br /><i>Jingwei Shao, Lisa McConnachie, and Rodney J.Y. Ho</i></p> <p>16.1 Introduction 403</p> <p>16.2 A Systems Approach to Drug Delivery and Drug Targeting 405</p> <p>16.3 Current Nanomedicine Products 407</p> <p>16.4 Transformation of a Discovery of Disease Target to a Therapeutic Product 410</p> <p>16.5 The Role of Targeted Nanoformulations and a Systems Approach in Drug Development 412</p> <p>16.6 Targeting Drugs to Sites of Action 413</p> <p>16.7 A Size-Dependent Targeting to Tissues and Cells 414</p> <p>16.8 Ligand–Receptor-Based Targeting: Active Drug Targeting 417</p> <p>16.9 Conclusions and Future Prospects 421</p> <p>References 422</p> <p><b>17 Nanoparticle Toxicity: General Overview and Insights Into Immunological Compatibility 425</b><br /><i>Marina A. Dobrovolskaia</i></p> <p>17.1 Introduction 425</p> <p>17.2 Systemic Toxicity 427</p> <p>17.3 Pulmonary Toxicity 428</p> <p>17.4 Cutaneous Toxicity 431</p> <p>17.5 Immunotoxicity 432</p> <p>17.6 Unintended Presence of Nanosized Materials in Pharmaceutical Formulations 434</p> <p>17.7 Conclusion 435</p> <p>Acknowledgments 435</p> <p>References 436</p> <p><b>18 An Overview of Nanoparticle Biocompatibility for Their Use in Nanomedicine 443</b><br /><i>Matthew S.P. Boyles, Leagh G. Powell, Ali Kermanizadeh, Helinor J. Johnston, Barbara Rothen-Rutishauser, Vicki Stone, and Martin J.D. Clift</i></p> <p>18.1 Introduction 443</p> <p>18.2 Nanomedicine 444</p> <p>18.3 Biocompatibility of Nanoparticles for Medical Application 445</p> <p>18.4 Summary 458</p> <p>References 459</p> <p><b>19 Translation to the Clinic: Preclinical and Clinical Pharmacology Studies of Nanoparticles – The Translational Challenge 469</b><br /><i>Rachel Tyson, Leah Osae, Andrew J. Madden, and Andrew T. Lucas, and William C. Zamboni</i></p> <p>19.1 Introduction 469</p> <p>19.2 Nanoparticle Formulations 469</p> <p>19.3 Pharmacokinetic Characterization 470</p> <p>19.4 Mononuclear Phagocyte System 470</p> <p>19.5 Delivery of CMA in Tumor 472</p> <p>19.6 Methods to Target Brain Tumors 475</p> <p>19.7 Physical Characteristics 477</p> <p>19.8 The Effect of MPS on CMA PK and PD 480</p> <p>19.9 Age 483</p> <p>19.10 Gender 486</p> <p>19.11 Tissue and Organ Effects 487</p> <p>19.12 Drug–Drug Interactions 488</p> <p>19.13 Prior Treatment 489</p> <p>19.14 Translational Challenges 490</p> <p>19.15 Future Perspectives on PK and PD 491</p> <p>References 492</p> <p><b>20 Regulatory Issues in Nanomedicines 497</b><br /><i>Marisa Papaluca, Falk Ehmann, Ruben Pita, and Dolores Hernan</i></p> <p>20.1 Nanomedicines and the Pharmaceuticals Regulatory Framework in Europe 497</p> <p>20.2 The European Medicines Agency and Nanomedicines 499</p> <p>20.3 Is It Important to Define Nanomedicines? 501</p> <p>20.4 Communicating About Nanomedicines 503</p> <p>20.5 Liposomal Formulations: State of Play at the EMA 504</p> <p>20.6 Nanosimilar Colloidal Intravenous Iron-Based Preparations 511</p> <p>20.7 International Landscape and Convergence on Nanomedicines 514</p> <p>20.8 Conclusions and Way Forward 517</p> <p>References 518</p> <p><b>21 Social Studies of Nanopharmaceutical Research 521</b><br /><i>Michael Schillmeier</i></p> <p>21.1 Engaging with Ethical, Legal, and Social Implications of Nanoresearch 521</p> <p>21.2 Nanopharmacy and the “Culture of Promise” 522</p> <p>21.3 From “Science Meets Society” to Translation as a Social Process 523</p> <p>21.4 Metaphors and Nanopharmacy 525</p> <p>21.5 Nanopharmacy and “Personalized Medicine” 526</p> <p>21.6 Concluding Remarks 528</p> <p>References 529</p> <p><b>Part Four Pharmaceutical Applications of Nanomaterials 533</b></p> <p><b>22 Nanoparticles for Imaging and Imaging Nanoparticles: State of the Art and Current Prospects 535</b><br /><i>Thomas Maldiney and Nathalie Mignet</i></p> <p>22.1 Introduction 535</p> <p>22.2 Conception of Nanotechnologies for Imaging 536</p> <p>22.3 In Vivo Nanoparticle Imaging to Gain Insight into Nanomedicine Biodistribution and Stability 544</p> <p>22.4 Translational Interest of Nanoparticles for Medical Imaging 548</p> <p>22.5 Conclusion 553</p> <p>References 553</p> <p><b>23 Nanoparticle-Based Physical Methods for Medical Treatments 561</b><br /><i>Christine Ménager</i></p> <p>23.1 Photothermal Therapy 561</p> <p>23.2 Photodynamic Therapy 565</p> <p>23.3 Magnetic Hyperthermia 567</p> <p>23.4 Radiotherapy 571</p> <p>23.5 Sonodynamic Therapy 572</p> <p>23.6 Cryosurgery 573</p> <p>23.7 Future Perspectives 574</p> <p>References 575</p> <p><b>24 Nanodrugs in Medicine and Healthcare: Oral Delivery 579</b><br /><i>Alejandro Sosnik</i></p> <p>24.1 General Aspects and Challenges of Oral Drug Delivery 579</p> <p>24.2 Pure Drug Micronization as a Conceptual Preamble to More Complex Drug Delivery 580</p> <p>24.3 Nanotechnology Platforms for Improved Oral Drug Delivery 581</p> <p>24.4 Conclusive Remarks 591</p> <p>Acknowledgments 591</p> <p>References 591</p> <p><b>25 Steroidal Nanodrugs Based on Pegylated Nanoliposomes Remote Loaded with Amphipathic Weak Acids Steroid Prodrugs as Anti-Inflammatory Agents 603</b><br /><i>Keren Turjeman and Yechezkel Barenholz</i></p> <p>25.1 A Short Relevant Background on Inflammatory and Autoimmune Diseases 603</p> <p>25.2 Drug Delivery Systems (DDS) Based on Nanoparticles (NP) for the Treatment of Diseases That Involve Inflammation 605</p> <p>25.3 Glucocorticosteroid as Anti-Inflammatory Agents 607</p> <p>25.4 Steroidal Nanodrugs Based on Pegylated Nanoliposomes Remote Loaded with Amphipathic Weak Acids Steroid Prodrugs as Anti-Inflammatory Agents 609</p> <p>25.5 Methods for Loading Drugs into Liposomes 610</p> <p>25.6 Comparing Various Approaches Used for Formulating Liposomal GCs 612</p> <p>25.7 The Use of Liposomes Loaded with Steroids as Anti-Inflammatory Agents: A Brief Historical Perspective 615</p> <p>25.8 Lessons Learned from Experimental Animal Models of Diseases That Involve Inflammation 618</p> <p>References 625</p> <p><b>26 Nanodrugs in Medicine and Healthcare: Pulmonary, Nasal and Ophthalmic Routes, and Vaccination 633</b><br /><i>Christel C. Müller-Goymann and Mukta Paranjpe</i></p> <p>26.1 Introduction 633</p> <p>26.2 Different Routes of Administration 634</p> <p>26.3 Different Types of Nanoparticles for Different Routes of Administration 638</p> <p>26.4 Manufacturing Processes of Nanoparticles 638</p> <p>26.5 Different Diseases Targeted Via Nanoparticle-Based Drug Delivery Systems 640</p> <p>26.6 Challenges Faced in Formulation Development of Nanoparticle-Based Systems 641</p> <p>References 642</p> <p><b>27 Neurodegenerative Diseases – Alzheimer’s Disease 649</b><br /><i>Maria Gregori and Francesca Re</i></p> <p>27.1 Introduction 649</p> <p>27.2 Diagnosis 650</p> <p>27.3 Therapy of Alzheimer’s Disease 653</p> <p>References 656</p> <p><b>Part Five The Nanopharmaceutical Market 661</b></p> <p><b>28 A Practical Guide to Translating Nanomedical Products 663</b><br /><i>Raj Bawa</i></p> <p>28.1 From the Laboratory to the Clinic: Overcoming the Valley of Death 666</p> <p>28.2 Irreproducible Preclinical Research: A Bottleneck for Translation? 673</p> <p>28.3 Protecting Inventions via Patents: The Cornerstone of Translation 678</p> <p>28.4 Terminology and Nomenclature: Lost in Translation 680</p> <p>28.5 Gaps in Regulatory Guidance 682</p> <p>28.6 Conclusions and Outlook 683</p> <p>28.7 Disclosures and Conflict of Interest 694</p> <p>References 694</p> <p><b>29 Development and Commercialization of Nanocarrier-Based Drug Products 697</b><br /><i>Marianne Ashford</i></p> <p>29.1 Drivers for New Medicines 697</p> <p>29.2 Current Marketed Nanomedicines 699</p> <p>29.3 Developing Nanomedicines 705</p> <p>29.4 Commercialization of Nanomedicines 722</p> <p>29.5 Conclusions 732</p> <p>References 732</p> <p><b>30 Future Outlook of Nanopharmacy: Challenges and Opportunities 735</b><br /><i>Dan Peer and Marcel Van de Voorde</i></p> <p>30.1 Matching the NC’s Delivery Mode of Action (MoA) to the Tumor Type 736</p> <p>30.2 Nonpredictive Animal Models 737</p> <p>30.3 The Lack of Reliable Techniques that can Efficiently Characterize NCs and Measure their Stability in the Human Body 737</p> <p>30.4 The Challenge of Scaling Up NCs 738</p> <p>References 740</p> <p>Index 743</p>
Jean Cornier is presently consultant to several companies in the areas of life science, new technologies and business development. He obtained his PhD from the University of Caen, France, and a MSc degree in pharmaceutical medicine from the University of Duisburg-Essen, Germany. Since 1986 he has worked in the space industry as expert in Materials and Life Science research and projects, was participant in space commercialisation initiatives supported by the European and German space agencies as well as in several EU-funded projects in biotechnology and civil security research.<br> <br> Professor Arno Kwade is Head of the Center of Pharmaceutical Engineering and of the Institute of Particle Technology at the Technical University Braunschweig, Germany. After his PhD he worked nine years in industry as partner of a consulting firm for processing and handling of materials and as general manager of a medium-sized company active in materials processing. Professor Kwade is speaker of the European working party on comminution and classification and developed a course on nanomilling, taken by more than 1000 participants from different industries, among them many pharmaceutical companies.<br> <br> Professor Andrew Owen holds a personal Chair in Molecular and Clinical Pharmacology at the University of Liverpool, UK. He is also affiliated to the MRC Centre for Drug Safety Science and the Wolfson Centre for Personalised Medicine. He is Chair of the British Society for Nanomedicine, is co-inventor of several patents related to nanomedicines and has contributed to over 150 publications and book chapters. He is co-founder of University commercial start-ups, a Fellow of the Royal Society of Biology, a Fellow of the British Pharmacological Society and member of the steering committee for the Academy of Pharmaceutical Sciences Nanomedicine Focus Group.<br> <br> Marcel Van de Voorde has 40 years` experience in European Research Organisations including CERN-Geneva, European Commission, with 10 years at the Max Planck Institute in Stuttgart, Germany. For many years, he was involved in research and research strategies, policy and management, especially in European research institutions. He holds a Professorship at the University of Technology in Delft, the Netherlands, as well as multiple visiting professorships in Europe and worldwide. He holds a doctor honoris causa and various honorary Professorships.<br> He is senator of the European Academy for Sciences and Arts, in Salzburg and Fellow of the World Academy for Sciences. He is a Fellow of various scientific societies and has been decorated by the Belgian King. He has authored of multiple scientific and technical publications and co-edited multiple books in the field of nanoscience and nanotechnology.

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