Pharmaceutical NanotechnologyInnovation and Production, 2 Volumes
Applications of Nanotechnology 1. Aufl.
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. 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!
Foreword XXVII Industrial Requirement on Nanopharmacy Research XXIX Introduction XXXI Volume 1 Part One Entry to the Nanopharmacy Revolution 1 1 History: Potential, Challenges, and Future Development in Nanopharmaceutical Research and Industry 3Albertina Ariën and Paul Stoffels 1.1 Nanopharmaceuticals in Cancer Therapy 4 1.2 Nanoparticles Actively Using the Host Machinery 5 1.3 Nanopharmaceuticals for Oral Administration and Long-Acting Injectable Therapy 8 1.4 Bridging Future Nanomedicines to Commercialization 10 1.5 Future Outlook 11 Acknowledgments 12 References 12 2 Nanoscale Drugs: A Key to Revolutionary Progress in Pharmacy and Healthcare 17Simon Sebastian Raesch, Marina Poettler, Christoph Alexiou, and Claus-Michael Lehr 2.1 Introduction 17 2.2 Nanopharmacy Concepts to Improve the Safety and Efficacy of Medicines 20 2.3 Technical Realization of Nanopharmaceuticals 30 2.4 Safety of Nanopharmaceuticals 34 2.5 Present and Future of Nanopharmacy 35 References 37 3 The Emergence of Nanopharmacy: From Biology to Nanotechnology and Drug Molecules to Nanodrugs 43Marilena Hadjidemetriou, Zahraa Al-Ahmady, Mariarosa Mazza, and Kostas Kostarelos 3.1 Introduction 43 3.2 First Generation of Nanopharmaceuticals: From Drug Molecules to Nanodrugs 45 3.3 Conclusion 55 References 56 4 Understanding and Characterizing Functional Properties of Nanoparticles 63Ester Polo, Valentina Castagnola, and Kenneth A. Dawson 4.1 Introduction 63 4.2 The Approach to Characterization 70 References 77 5 Omics-Based Nanopharmacy: Powerful Tools Toward Precision Medicine 81Daniel Rosenblum and Dan Peer 5.1 Introduction 81 5.2 Precision Medicine 82 5.3 “OMICS” – New Era in Understanding Pathology 86 5.4 Nanomedicine 90 5.5 Future Outlook 93 Acknowledgments 96 References 96 Part Two Fundamentals of Nanotechnology in Pharmacy 101 6 Nanostructures in Drug Delivery 103Salma Nabil Tammam and Alf Lamprecht 6.1 Introduction 103 6.2 Nanocarrier Classification 103 6.2.1 Inorganic Nanostructures 104 6.3 Drug Loading and Release 116 6.4 General Discussion and Conclusions 123 References 124 7 Characterization Methods: Physical and Chemical Characterization Techniques 135Sven Even F. Borgos 7.1 The Need for Nanomedicine-Specific Characterization 135 7.2 The Assay Cascade: From Basic Properties to Complex Interactions 136 7.3 Physicochemical Characterization of Pristine Nanoparticles 137 7.4 Characterization of Nanoparticles in the Biological Environment 144 7.5 Conclusions and Future Outlook 149 References 150 8 Nanoparticle Characterization Methods: Applications of Synchrotron and Neutron Radiation 157Martha 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 8.1 Advanced Characterization: Synchrotron Light and Neutron Sources 157 8.2 Application Examples 159 8.3 Going Beyond Characterization Using Synchrotron X-rays: Nanoparticles for Diagnostic and Therapeutic pproaches 168 8.4 Looking Ahead and Conclusions 169 Acknowledgments 170 References 171 9 Overview of Techniques and Description of Established Processes 175Jan Henrik Finke, Michael Juhnke, Arno Kwade, and Heike Bunjes 9.1 Introduction 175 9.2 Processing of Liquid Drug Carrier Formulations 176 9.3 Drug Nanoparticles and Process Chains to Solid Formulations 192 9.4 Industrial Status and Framework 215 9.5 Perspectives for Academia, Industry, and Regulatory Authorities 216 References 217 10 Nanopharmacy: Exploratory Methods for Polymeric Materials 231Kuldeep Bansal, Luana Sasso, Hiteshri Makwana, Sahar Awwad, Steve Brocchini, and Cameron Alexander 10.1 Introduction 231 10.2 Rationale for the Use of Polymers in Nanomedicines 232 10.3 Polymer Structures and Properties 234 10.4 Formulation of Copolymers into Micelles, Vesicles, and Nanoparticles 236 10.5 Conjugation of Polymers to Drugs and Proteins 240 10.6 Recent Advances in Polymer Synthesis for Therapeutic Applications 248 10.7 Controlled Radical Polymerization (CRP) 259 10.8 Concluding Remarks 260 References 261 11 Overview and Presentation of Exploratory Methods for Manufacturing Nanoparticles/“Inorganic Materials” 271Xavier Le Guevel 11.1 Introduction 271 11.2 Gold NPs 272 11.3 Magnetic NPs 279 11.4 Metal Oxide NPs 282 11.5 Others (Silver, Quantum Dots, and Lanthanides) 284 11.6 Conclusion and Perspective 285 Acknowledgment 285 References 285 12 Scale-Up and cGMP Manufacturing of Nanodrug Delivery Systems for Clinical Investigations 295Mostafa Nakach and Jean-René Authelin 12.1 Introduction 295 12.2 Presentation of Major Manufacturing Processes of Different Nanodrug Delivery Systems 296 12.3 Nanodrug Delivery Systems as Marketed Products 302 12.4 Particle/Vesicle Size Reduction Technologies 302 12.5 Process Development and Scale-Down/Scale-Up Strategy 308 12.6 Technological Concept for Manufacture of Drug Product for Human Use (GMP Unit) 322 12.7 Conclusion 327 References 327 13 Occupational Safety and Health 331Thomas H. Brock 13.1 Nanomaterials at the Workplace 331 13.2 Legal Aspects 335 13.3 Management of Uncertainty 336 13.4 Risks of Nanomaterials for Researchers and Workers 336 13.5 Prudent Practices and Proven Concepts for Controlling Risks 338 13.6 Instruction and Training 351 13.7 Summary 352 References 352 Volume 2 Part Three Development of Nanopharmaceuticals 355 14 Micro- and Nano-Tools in Drug Discovery 357Andreas Dietzel, Monika Leester-Schädel, and Stephan Reichl 14.1 Introduction 357 14.2 General Concepts of Miniaturization 357 14.3 Micro- and Nanofabrication 359 14.4 Nanoformulation 367 14.5 Organ-on-a-Chip 372 References 375 15 Computational Predictive Models for Nanomedicine 379Marco Siccardi, Alessandro Schipani, and Andrew Owen 15.1 Introduction 379 15.2 Molecular Modeling in Nanomedicine 381 15.3 Computational Approaches for Predicting Nanotoxicology 384 15.4 Simulation of Nanoparticle Pharmacokinetics 386 15.5 Conclusion 395 References 397 16 Drug Targeting in Nanomedicine and Nanopharmacy: A Systems Approach 403Jingwei Shao, Lisa McConnachie, and Rodney J.Y. Ho 16.1 Introduction 403 16.2 A Systems Approach to Drug Delivery and Drug Targeting 405 16.3 Current Nanomedicine Products 407 16.4 Transformation of a Discovery of Disease Target to a Therapeutic Product 410 16.5 The Role of Targeted Nanoformulations and a Systems Approach in Drug Development 412 16.6 Targeting Drugs to Sites of Action 413 16.7 A Size-Dependent Targeting to Tissues and Cells 414 16.8 Ligand–Receptor-Based Targeting: Active Drug Targeting 417 16.9 Conclusions and Future Prospects 421 References 422 17 Nanoparticle Toxicity: General Overview and Insights Into Immunological Compatibility 425Marina A. Dobrovolskaia 17.1 Introduction 425 17.2 Systemic Toxicity 427 17.3 Pulmonary Toxicity 428 17.4 Cutaneous Toxicity 431 17.5 Immunotoxicity 432 17.6 Unintended Presence of Nanosized Materials in Pharmaceutical Formulations 434 17.7 Conclusion 435 Acknowledgments 435 References 436 18 An Overview of Nanoparticle Biocompatibility for Their Use in Nanomedicine 443Matthew S.P. Boyles, Leagh G. Powell, Ali Kermanizadeh, Helinor J. Johnston, Barbara Rothen-Rutishauser, Vicki Stone, and Martin J.D. Clift 18.1 Introduction 443 18.2 Nanomedicine 444 18.3 Biocompatibility of Nanoparticles for Medical Application 445 18.4 Summary 458 References 459 19 Translation to the Clinic: Preclinical and Clinical Pharmacology Studies of Nanoparticles – The Translational Challenge 469Rachel Tyson, Leah Osae, Andrew J. Madden, and Andrew T. Lucas, and William C. Zamboni 19.1 Introduction 469 19.2 Nanoparticle Formulations 469 19.3 Pharmacokinetic Characterization 470 19.4 Mononuclear Phagocyte System 470 19.5 Delivery of CMA in Tumor 472 19.6 Methods to Target Brain Tumors 475 19.7 Physical Characteristics 477 19.8 The Effect of MPS on CMA PK and PD 480 19.9 Age 483 19.10 Gender 486 19.11 Tissue and Organ Effects 487 19.12 Drug–Drug Interactions 488 19.13 Prior Treatment 489 19.14 Translational Challenges 490 19.15 Future Perspectives on PK and PD 491 References 492 20 Regulatory Issues in Nanomedicines 497Marisa Papaluca, Falk Ehmann, Ruben Pita, and Dolores Hernan 20.1 Nanomedicines and the Pharmaceuticals Regulatory Framework in Europe 497 20.2 The European Medicines Agency and Nanomedicines 499 20.3 Is It Important to Define Nanomedicines? 501 20.4 Communicating About Nanomedicines 503 20.5 Liposomal Formulations: State of Play at the EMA 504 20.6 Nanosimilar Colloidal Intravenous Iron-Based Preparations 511 20.7 International Landscape and Convergence on Nanomedicines 514 20.8 Conclusions and Way Forward 517 References 518 21 Social Studies of Nanopharmaceutical Research 521Michael Schillmeier 21.1 Engaging with Ethical, Legal, and Social Implications of Nanoresearch 521 21.2 Nanopharmacy and the “Culture of Promise” 522 21.3 From “Science Meets Society” to Translation as a Social Process 523 21.4 Metaphors and Nanopharmacy 525 21.5 Nanopharmacy and “Personalized Medicine” 526 21.6 Concluding Remarks 528 References 529 Part Four Pharmaceutical Applications of Nanomaterials 533 22 Nanoparticles for Imaging and Imaging Nanoparticles: State of the Art and Current Prospects 535Thomas Maldiney and Nathalie Mignet 22.1 Introduction 535 22.2 Conception of Nanotechnologies for Imaging 536 22.3 In Vivo Nanoparticle Imaging to Gain Insight into Nanomedicine Biodistribution and Stability 544 22.4 Translational Interest of Nanoparticles for Medical Imaging 548 22.5 Conclusion 553 References 553 23 Nanoparticle-Based Physical Methods for Medical Treatments 561Christine Ménager 23.1 Photothermal Therapy 561 23.2 Photodynamic Therapy 565 23.3 Magnetic Hyperthermia 567 23.4 Radiotherapy 571 23.5 Sonodynamic Therapy 572 23.6 Cryosurgery 573 23.7 Future Perspectives 574 References 575 24 Nanodrugs in Medicine and Healthcare: Oral Delivery 579Alejandro Sosnik 24.1 General Aspects and Challenges of Oral Drug Delivery 579 24.2 Pure Drug Micronization as a Conceptual Preamble to More Complex Drug Delivery 580 24.3 Nanotechnology Platforms for Improved Oral Drug Delivery 581 24.4 Conclusive Remarks 591 Acknowledgments 591 References 591 25 Steroidal Nanodrugs Based on Pegylated Nanoliposomes Remote Loaded with Amphipathic Weak Acids Steroid Prodrugs as Anti-Inflammatory Agents 603Keren Turjeman and Yechezkel Barenholz 25.1 A Short Relevant Background on Inflammatory and Autoimmune Diseases 603 25.2 Drug Delivery Systems (DDS) Based on Nanoparticles (NP) for the Treatment of Diseases That Involve Inflammation 605 25.3 Glucocorticosteroid as Anti-Inflammatory Agents 607 25.4 Steroidal Nanodrugs Based on Pegylated Nanoliposomes Remote Loaded with Amphipathic Weak Acids Steroid Prodrugs as Anti-Inflammatory Agents 609 25.5 Methods for Loading Drugs into Liposomes 610 25.6 Comparing Various Approaches Used for Formulating Liposomal GCs 612 25.7 The Use of Liposomes Loaded with Steroids as Anti-Inflammatory Agents: A Brief Historical Perspective 615 25.8 Lessons Learned from Experimental Animal Models of Diseases That Involve Inflammation 618 References 625 26 Nanodrugs in Medicine and Healthcare: Pulmonary, Nasal and Ophthalmic Routes, and Vaccination 633Christel C. Müller-Goymann and Mukta Paranjpe 26.1 Introduction 633 26.2 Different Routes of Administration 634 26.3 Different Types of Nanoparticles for Different Routes of Administration 638 26.4 Manufacturing Processes of Nanoparticles 638 26.5 Different Diseases Targeted Via Nanoparticle-Based Drug Delivery Systems 640 26.6 Challenges Faced in Formulation Development of Nanoparticle-Based Systems 641 References 642 27 Neurodegenerative Diseases – Alzheimer’s Disease 649Maria Gregori and Francesca Re 27.1 Introduction 649 27.2 Diagnosis 650 27.3 Therapy of Alzheimer’s Disease 653 References 656 Part Five The Nanopharmaceutical Market 661 28 A Practical Guide to Translating Nanomedical Products 663Raj Bawa 28.1 From the Laboratory to the Clinic: Overcoming the Valley of Death 666 28.2 Irreproducible Preclinical Research: A Bottleneck for Translation? 673 28.3 Protecting Inventions via Patents: The Cornerstone of Translation 678 28.4 Terminology and Nomenclature: Lost in Translation 680 28.5 Gaps in Regulatory Guidance 682 28.6 Conclusions and Outlook 683 28.7 Disclosures and Conflict of Interest 694 References 694 29 Development and Commercialization of Nanocarrier-Based Drug Products 697Marianne Ashford 29.1 Drivers for New Medicines 697 29.2 Current Marketed Nanomedicines 699 29.3 Developing Nanomedicines 705 29.4 Commercialization of Nanomedicines 722 29.5 Conclusions 732 References 732 30 Future Outlook of Nanopharmacy: Challenges and Opportunities 735Dan Peer and Marcel Van de Voorde 30.1 Matching the NC’s Delivery Mode of Action (MoA) to the Tumor Type 736 30.2 Nonpredictive Animal Models 737 30.3 The Lack of Reliable Techniques that can Efficiently Characterize NCs and Measure their Stability in the Human Body 737 30.4 The Challenge of Scaling Up NCs 738 References 740 Index 743
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. 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. 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. 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. 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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