This book serves as a unique resource on the field of novel drug delivery systems (NDDSs), catering to both academic audiences (researchers, teachers, students) and industry professionals (pharmaceutical policymakers, managers, R&D, regulatory, business development, and marketing) involved in NDDSs. The evolving nature of diseases and the emergence of new health complications have driven a significant shift in drug therapy. Coupled with changes in human lifestyles and economic conditions, these factors have compelled the pharmaceutical industry to develop novel, efficient, and affordable drug…mehr
This book serves as a unique resource on the field of novel drug delivery systems (NDDSs), catering to both academic audiences (researchers, teachers, students) and industry professionals (pharmaceutical policymakers, managers, R&D, regulatory, business development, and marketing) involved in NDDSs. The evolving nature of diseases and the emergence of new health complications have driven a significant shift in drug therapy. Coupled with changes in human lifestyles and economic conditions, these factors have compelled the pharmaceutical industry to develop novel, efficient, and affordable drug products. The rise of promising technologies aimed at enhancing therapeutic performance further underscores the importance of novel drug delivery systems (NDDSs), making this field one of the most dynamic in pharmaceutical sciences today. This book offers a comprehensive exploration of NDDS applications, catering to both academic and industry professionals. It is designed to be both user-friendly and thorough, meeting the needs of diverse readers-from those seeking practical insights to those delving deeply into the field's various sectors. The content has been meticulously compiled, organized, and analyzed by a team of experts to ensure accuracy, relevance, and currency. The book provides up-to-date information suitable for a broad audience, reflecting the wide scope of the NDDS field. The first section covers the foundational principles of NDDS, including their scientific and therapeutic basis, as well as the epidemiological and economic trends driving their development. Subsequent sections explore market-oriented aspects, such as global trends and projections. Chapters 3 to 12 present a taxonomy of NDDS categorized by their routes of administration. The book concludes with a forward-looking report on the potential future directions of NDDS. Written in clear, concise language, the book is accessible to non-native English readers, ensuring broad usability. Original figures, created by experts with scientific and graphic design expertise, enhance the reading experience and aid in understanding complex concepts. Audience A wide variety of professional readers from universities and other research institutions to health industries (industrial pharmaceutical and related), to the relevant high-tech startups to health and pharma policymakers and managers will be among the audiences of this book.
Mehrdad Hamidi, PhD, obtained his doctorate from the Tehran University of Medical Sciences, Tehran, Iran in 1999. His main research field is novel delivery systems focusing on BBB transport of CNS-active drugs. He has published many articles in international journals, two books, multiple book chapters, three contributions to an encyclopedia, and 5 US patents. Concurrently, he is a member of the Iranian Academy of Medical Sciences, the Founding Chairman and Founding CEO of two knowledge-based entrepreneurial pharmaceutical companies, and the Chair of the Iranian Association of Pharmaceutical Scientists. Mahsa Sayed Tabatabaei, PhD, obtained her doctorate at Shahid Behesthi University of Medical Sciences, Iran in 2022. She is currently a pharmaceutical R&D Project Manager at Hida Pharma in Tehran engaged in different nanotechnology-based drug delivery projects, mainly drug self-delivery systems, peptide and protein delivery, self-assembled nanostructures, and novel cosmeceuticals.
Inhaltsangabe
Preface xix 1 Introduction to Novel Drug Delivery Systems 1 Mehrdad Hamidi, Mahsa Sayed Tabatabaei, Mohammad Moslehi and Maedeh Barati 1.1 Historical Background 2 1.2 Definition, Terminology, and Taxonomy 3 1.3 Novel Drug Delivery Systems: Why, How, and What to Deliver? 4 References 25 2 Novel Drug Delivery Systems: Approach to the Market 35 Maryam Motamedi and Mahsa Sayed Tabatabaei 2.1 Introduction 36 2.2 Novel Drug Delivery Systems Global Market 36 2.3 Emerging Diseases, Emerging Technologies 54 2.4 New Development Areas 56 References 61 3 Intraoral Novel Drug Delivery Systems 67 Seyedeh Maryam Mortazavi, Leila Sayed-Tabatabaei, Mahsa Sayed Tabatabaei and Azadeh Vaezi Moghaddam 3.1 Introduction 68 3.2 Anatomy and Physiology 68 3.3 Factors Affecting Intraoral Drug Delivery 71 3.4 Challenges and Opportunities 72 3.5 Classification and Formulation Considerations 73 3.6 Pharmacokinetics 90 3.7 Products in the Market 92 References 97 4 Oral Novel Drug Delivery Systems 103 Mahsa Sayed Tabatabaei 4.1 Introduction 104 4.2 Anatomy and Physiology of Gastrointestinal Tract 105 4.3 Barriers to Oral Drug Delivery 108 4.4 Factors Affecting Oral Drug Delivery 113 4.5 Challenges and Opportunities of Oral Drug Delivery 120 4.6 Classification of Oral Novel Drug Delivery Systems 121 4.7 Pharmacokinetics 145 4.8 Products in the Market 147 References 154 5 Rectal Novel Drug Delivery Systems 167 Mahsa Sayed Tabatabaei and Taraneh Gazori 5.1 Introduction 168 5.2 Anatomy and Physiology 169 5.3 Barriers to Rectal Drug Delivery 170 5.4 Factors Affecting Rectal Drug Delivery 172 5.5 Formulation Considerations 175 5.6 Challenges and Opportunities of Rectal Drug Delivery 178 5.7 Classification of Rectal Novel Drug Delivery Systems 178 5.8 Pharmacokinetics 188 5.9 Products in the Market 190 References 192 6 Injectable Novel Drug Delivery Systems 199 Payam Khazaeli and Marzieh SajadiBami 6.1 Introduction 200 6.2 Anatomy and Physiology 202 6.3 Parenteral Administration Routes 203 6.4 Classification 208 6.5 Formulation Considerations 222 6.6 Pharmacokinetics 222 6.7 Products in the Market 224 References 226 7 Implantable Drug Delivery Systems 235 Nasrin Zarei Chamgordani 7.1 Introduction 236 7.2 Anatomy and Physiology 237 7.3 Classification and Formulation Considerations 243 7.4 Challenges and Opportunities 262 7.5 Pharmacokinetics 264 7.6 Products in the Market 267 References 268 8 Inhalable Novel Drug Delivery Systems 275 Mahdieh Farhangi and Fariba Hajifathaliha 8.1 Introduction 276 8.2 Anatomy and Physiology 277 8.3 Factors Affecting Pulmonary Drug Delivery 280 8.4 Challenges and Opportunities 286 8.5 Classification and Formulation Considerations 287 8.6 Pharmacokinetics 295 8.7 Products in the Market 297 References 299 9 Intranasal Novel Drug Delivery Systems 307 Mehrnoosh Nikpour 9.1 Introduction 308 9.2 Anatomy and Physiology 309 9.3 Factors Affecting Intranasal Drug Delivery 313 9.4 Challenges and Opportunities 322 9.5 Classification and Formulation Considerations 325 9.6 Pharmacokinetics 327 9.7 Products in the Market 331 References 340 10 Dermal and Transdermal Novel Drug Delivery Systems 349 Shiva Hashemi, Saeedeh Abedin, Azadeh Vaezi Moghaddam and Mahsa Sayed Tabatabaei 10.1 Introduction 350 10.2 Anatomy and Physiology 351 10.3 Barriers to Transdermal Drug Delivery 353 10.4 Factors Affecting Dermal/Transdermal Drug Delivery 354 10.5 Challenges and Opportunities 358 10.6 Classification and Formulation Considerations 359 10.7 Pharmacokinetics 375 10.8 Products in the Market 383 References 386 11 Ocular Novel Drug Delivery Systems 393 Payam Khazaeli, Mahsa Sayed Tabatabaei, Leila Sayed-Tabatabaei and Mohammad Amin Raeisi Estabragh 11.1 Introduction 394 11.2 Anatomy and Physiology 395 11.3 Barriers to Ocular Drug Delivery 396 11.4 Challenges and Opportunities 401 11.5 Formulation Considerations 401 11.6 Classification 405 11.7 Pharmacokinetics 411 11.8 Products in the Market 411 References 414 12 Vaginal Novel Drug Delivery Systems 419 Yasaman Khajeamiri and Solmaz Ghaffari 12.1 Introduction 420 12.2 Anatomy and Physiology 421 12.3 Barriers to Vaginal Drug Delivery 422 12.4 Formulation Considerations 424 12.5 Classification 427 12.6 Pharmacokinetics 437 12.7 Products in the Market 438 References 440 13 Future of Novel Drug Delivery Systems 449 Mehrdad Hamidi, Mehraneh Kermanian and Masoumeh Kurd 13.1 Introduction 450 13.2 Drug Delivery Challenges to be Overcome in the Future 450 13.2.1 Drug Delivery Barriers 450 13.2.2 Burst Release 451 13.2.3 Real-Time Monitoring Issues 453 13.2.4 High Interindividual Variations 454 13.2.4.1 Personalized Controlled-Release 454 13.2.4.2 Personalized System Design 455 13.2.5 High Cost of Novel Systems 455 13.2.6 Low Patient Compliance 456 13.3 Drug Delivery Opportunities to be Seized in the Future 456 13.3.1 Artificial Intelligence 456 13.3.2 Novel Techniques 458 13.3.2.1 Microfluidic 458 13.3.2.2 3D Printing 458 13.3.3 New Visions in Biology 460 13.3.4 New Therapeutic Agents, Protocols, and Strategies 460 13.3.4.1 Biopharmaceuticals 460 13.3.4.2 Combinatory Drug Delivery Systems 461 13.3.4.3 Theranostics 462 13.3.4.4 Bio-Inspired Drug Delivery Systems 463 13.3.5 Emerging Technologies 464 13.3.6 Interdisciplinary Development 465 13.4 Concluding Remarks 465 Index 467
Preface xix 1 Introduction to Novel Drug Delivery Systems 1 Mehrdad Hamidi, Mahsa Sayed Tabatabaei, Mohammad Moslehi and Maedeh Barati 1.1 Historical Background 2 1.2 Definition, Terminology, and Taxonomy 3 1.3 Novel Drug Delivery Systems: Why, How, and What to Deliver? 4 References 25 2 Novel Drug Delivery Systems: Approach to the Market 35 Maryam Motamedi and Mahsa Sayed Tabatabaei 2.1 Introduction 36 2.2 Novel Drug Delivery Systems Global Market 36 2.3 Emerging Diseases, Emerging Technologies 54 2.4 New Development Areas 56 References 61 3 Intraoral Novel Drug Delivery Systems 67 Seyedeh Maryam Mortazavi, Leila Sayed-Tabatabaei, Mahsa Sayed Tabatabaei and Azadeh Vaezi Moghaddam 3.1 Introduction 68 3.2 Anatomy and Physiology 68 3.3 Factors Affecting Intraoral Drug Delivery 71 3.4 Challenges and Opportunities 72 3.5 Classification and Formulation Considerations 73 3.6 Pharmacokinetics 90 3.7 Products in the Market 92 References 97 4 Oral Novel Drug Delivery Systems 103 Mahsa Sayed Tabatabaei 4.1 Introduction 104 4.2 Anatomy and Physiology of Gastrointestinal Tract 105 4.3 Barriers to Oral Drug Delivery 108 4.4 Factors Affecting Oral Drug Delivery 113 4.5 Challenges and Opportunities of Oral Drug Delivery 120 4.6 Classification of Oral Novel Drug Delivery Systems 121 4.7 Pharmacokinetics 145 4.8 Products in the Market 147 References 154 5 Rectal Novel Drug Delivery Systems 167 Mahsa Sayed Tabatabaei and Taraneh Gazori 5.1 Introduction 168 5.2 Anatomy and Physiology 169 5.3 Barriers to Rectal Drug Delivery 170 5.4 Factors Affecting Rectal Drug Delivery 172 5.5 Formulation Considerations 175 5.6 Challenges and Opportunities of Rectal Drug Delivery 178 5.7 Classification of Rectal Novel Drug Delivery Systems 178 5.8 Pharmacokinetics 188 5.9 Products in the Market 190 References 192 6 Injectable Novel Drug Delivery Systems 199 Payam Khazaeli and Marzieh SajadiBami 6.1 Introduction 200 6.2 Anatomy and Physiology 202 6.3 Parenteral Administration Routes 203 6.4 Classification 208 6.5 Formulation Considerations 222 6.6 Pharmacokinetics 222 6.7 Products in the Market 224 References 226 7 Implantable Drug Delivery Systems 235 Nasrin Zarei Chamgordani 7.1 Introduction 236 7.2 Anatomy and Physiology 237 7.3 Classification and Formulation Considerations 243 7.4 Challenges and Opportunities 262 7.5 Pharmacokinetics 264 7.6 Products in the Market 267 References 268 8 Inhalable Novel Drug Delivery Systems 275 Mahdieh Farhangi and Fariba Hajifathaliha 8.1 Introduction 276 8.2 Anatomy and Physiology 277 8.3 Factors Affecting Pulmonary Drug Delivery 280 8.4 Challenges and Opportunities 286 8.5 Classification and Formulation Considerations 287 8.6 Pharmacokinetics 295 8.7 Products in the Market 297 References 299 9 Intranasal Novel Drug Delivery Systems 307 Mehrnoosh Nikpour 9.1 Introduction 308 9.2 Anatomy and Physiology 309 9.3 Factors Affecting Intranasal Drug Delivery 313 9.4 Challenges and Opportunities 322 9.5 Classification and Formulation Considerations 325 9.6 Pharmacokinetics 327 9.7 Products in the Market 331 References 340 10 Dermal and Transdermal Novel Drug Delivery Systems 349 Shiva Hashemi, Saeedeh Abedin, Azadeh Vaezi Moghaddam and Mahsa Sayed Tabatabaei 10.1 Introduction 350 10.2 Anatomy and Physiology 351 10.3 Barriers to Transdermal Drug Delivery 353 10.4 Factors Affecting Dermal/Transdermal Drug Delivery 354 10.5 Challenges and Opportunities 358 10.6 Classification and Formulation Considerations 359 10.7 Pharmacokinetics 375 10.8 Products in the Market 383 References 386 11 Ocular Novel Drug Delivery Systems 393 Payam Khazaeli, Mahsa Sayed Tabatabaei, Leila Sayed-Tabatabaei and Mohammad Amin Raeisi Estabragh 11.1 Introduction 394 11.2 Anatomy and Physiology 395 11.3 Barriers to Ocular Drug Delivery 396 11.4 Challenges and Opportunities 401 11.5 Formulation Considerations 401 11.6 Classification 405 11.7 Pharmacokinetics 411 11.8 Products in the Market 411 References 414 12 Vaginal Novel Drug Delivery Systems 419 Yasaman Khajeamiri and Solmaz Ghaffari 12.1 Introduction 420 12.2 Anatomy and Physiology 421 12.3 Barriers to Vaginal Drug Delivery 422 12.4 Formulation Considerations 424 12.5 Classification 427 12.6 Pharmacokinetics 437 12.7 Products in the Market 438 References 440 13 Future of Novel Drug Delivery Systems 449 Mehrdad Hamidi, Mehraneh Kermanian and Masoumeh Kurd 13.1 Introduction 450 13.2 Drug Delivery Challenges to be Overcome in the Future 450 13.2.1 Drug Delivery Barriers 450 13.2.2 Burst Release 451 13.2.3 Real-Time Monitoring Issues 453 13.2.4 High Interindividual Variations 454 13.2.4.1 Personalized Controlled-Release 454 13.2.4.2 Personalized System Design 455 13.2.5 High Cost of Novel Systems 455 13.2.6 Low Patient Compliance 456 13.3 Drug Delivery Opportunities to be Seized in the Future 456 13.3.1 Artificial Intelligence 456 13.3.2 Novel Techniques 458 13.3.2.1 Microfluidic 458 13.3.2.2 3D Printing 458 13.3.3 New Visions in Biology 460 13.3.4 New Therapeutic Agents, Protocols, and Strategies 460 13.3.4.1 Biopharmaceuticals 460 13.3.4.2 Combinatory Drug Delivery Systems 461 13.3.4.3 Theranostics 462 13.3.4.4 Bio-Inspired Drug Delivery Systems 463 13.3.5 Emerging Technologies 464 13.3.6 Interdisciplinary Development 465 13.4 Concluding Remarks 465 Index 467
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