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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.
Preface xix
1 Introduction to Novel Drug Delivery Systems 1Mehrdad 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 35Maryam 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 67Seyedeh 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 103Mahsa 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 167Mahsa 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 199Payam 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 235Nasrin 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 275Mahdieh 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 307Mehrnoosh 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 349Shiva 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 393Payam 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 419Yasaman 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 449Mehrdad 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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