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Submit a ProposalNovel Drug Delivery Systems
 | Fundamentals and Applications Edited by Mehrdad Hamidi and Mahsa Sayed Tabatabaei Copyright: 2025 | Status: Published ISBN: 9781119852285 | Hardcover | 496 pages Price: $225 USD  |
One Line Description
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.
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.
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.
Description
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.
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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.
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Author / Editor Details
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.
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.
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Table of Contents
Preface
1. Introduction to Novel Drug Delivery Systems
Mehrdad Hamidi, Mahsa Sayed Tabatabaei, Mohammad Moslehi and Maedeh Barati
1.1 Historical Background
1.2 Definition, Terminology, and Taxonomy
1.3 Novel Drug Delivery Systems: Why, How, and What to Deliver?
1.3.1 Why Delivery?
1.3.1.1 Liberation
1.3.1.2 Absorption
1.3.1.3 Distribution
1.3.1.4 Metabolism
1.3.1.5 Excretion
1.3.2 How to Deliver?
1.3.2.1 Drug Delivery Barriers
1.3.2.2 Overcoming Strategies
1.3.2.3 Designing Criteria of NDDSs
1.3.3 What to Deliver?
1.3.3.1 Small Molecules
1.3.3.2 Biopharmaceuticals
References
2. Novel Drug Delivery Systems: Approach to the Market
Maryam Motamedi and Mahsa Sayed Tabatabaei
2.1 Introduction
2.2 Novel Drug Delivery Systems Global Market
2.2.1 Macroeconomic Indicators Affecting the Market Growth
2.2.2 Novel Drug Delivery Systems
2.2.3 Key Market Trends
2.2.4 Market Segmentation
2.2.5 Therapeutic Areas
2.2.6 Nanotechnology-Based Formulations
2.2.7 The Importance of Communicating Value
2.3 Emerging Diseases, Emerging Technologies
2.3.1 Demographic Factors
2.3.2 Socioeconomic Grounds
2.3.3 Environmental Reasons
2.3.4 Political Considerations
2.3.5 Technological Aspects
2.4 New Development Areas
2.4.1 Poorly Water-Soluble Drugs
2.4.2 Prodrugs
2.4.3 Biopharmaceuticals
2.4.4 Vaccines
2.4.5 Herbal Drugs
2.4.6 Microcarriers and Nanocarriers
2.4.7 Cell Carriers
2.4.8 Biomimetics
2.4.9 Drug Delivery Devices
2.4.10 Codelivery Systems
2.4.11 Self-Delivery Systems
2.4.12 Smart (Stimuli-Responsive) Systems
2.4.13 Theranostics
2.4.14 Noninvasive Drug Administration Routes
2.4.15 Brain Drug Delivery
2.4.16 Lymphatic Drug Delivery
References
3. Intraoral Novel Drug Delivery Systems
Seyedeh Maryam Mortazavi, Leila Sayed-Tabatabaei, Mahsa Sayed Tabatabaei and Azadeh Vaezi Moghaddam
3.1 Introduction
3.2 Anatomy and Physiology
3.3 Factors Affecting Intraoral Drug Delivery
3.3.1 Salivary Flow
3.3.2 pH of Saliva
3.3.3 Salivary Secretory Disorders, Medications, and Therapeutic Interventions
3.3.4 Smoking
3.3.5 Alcohol Consumption
3.3.6 Residence Time of Formulation
3.4 Challenges and Opportunities
3.5 Classification and Formulation Considerations
3.5.1 Orodispersible Dosage Forms (On the Tongue)
3.5.1.1 Orodispersible Tablets
3.5.1.2 Orodispersible Films
3.5.1.3 Orodispersible Granules
3.5.1.4 Oral Lyophilizates
3.5.1.5 Nanoparticles in Orodispersible Formulations
3.5.2 Sublingual Dosage Forms (Under the Tongue)
3.5.2.1 Sublingual Tablets
3.5.2.2 Sublingual Films or Strips
3.5.2.3 Sublingual Solutions
3.5.2.4 Sublingual Soft Gelatine
3.5.2.5 Nanoparticles in Sublingual Formulations
3.5.3 Buccal Dosage Forms
3.5.3.1 Buccal Tablets
3.5.3.2 Buccal Films/Patches
3.5.3.3 Microneedle Platforms
3.5.3.4 Needle-Free Injectors
3.5.3.5 Buccal Solutions
3.5.3.6 Nanoparticles in Buccal Formulations
3.5.4 Gingival/Periodontal Dosage Forms
3.5.4.1 Gingival/Periodontal Gels
3.5.4.2 Gingival/Periodontal Chips
3.5.4.3 Gingival/Periodontal Rinse Solutions
3.5.4.4 Biodegradable Microspheres and Nanoparticles
3.5.5 Dental Drug Delivery Systems
3.5.5.1 Drug-Eluting Implants and Screws
3.5.5.2 Smart Dental Implants
3.5.5.3 Dental Patches
3.5.5.4 Nanoparticles for Dental Drug Delivery
3.5.6 Soft-Palatal Platforms
3.5.6.1 Soft-Palatal Solutions
3.5.6.2 Soft-Palatal Patches
3.5.7 Translabial Drug Delivery Systems
3.5.8 Intraoral Dosage Forms with Nonspecific Site
3.5.8.1 Chewable Dosage Forms: Pastilles and Tablets
3.5.8.2 Lollipops
3.5.8.3 Lozenges
3.6 Pharmacokinetics
3.7 Products in the Market
References
4. Oral Novel Drug Delivery Systems
Mahsa Sayed Tabatabaei
4.1 Introduction
4.2 Anatomy and Physiology of Gastrointestinal Tract
4.3 Barriers to Oral Drug Delivery
4.3.1 Biochemical (Stability) Barriers
4.3.2 Physical (Permeability) Barriers
4.3.3 Cellular (Epithelial) Barrier
4.3.4 Hepatic First-Pass Metabolism (Metabolic Barrier)
4.4 Factors Affecting Oral Drug Delivery
4.4.1 Physiological Factors
4.4.2 Pathological Conditions
4.4.3 Demographic Characteristics
4.4.4 Physicochemical/Pharmaceutical Parameters
4.5 Challenges and Opportunities of Oral Drug Delivery
4.6 Classification of Oral Novel Drug Delivery Systems
4.6.1 Regional Drug Delivery to the Esophagus
4.6.1.1 EsoCap Technology
4.6.1.2 Other Retentive Devices
4.6.2 Regional Drug Delivery to the Stomach
4.6.2.1 Floating (Low-Density) Gastroretentive Systems
4.6.2.2 Sinking (High-Density) Gastroretentive Systems
4.6.2.3 Expandable (Size-Increasing) Gastroretentive Systems
4.6.2.4 Bio/Mucoadhesive Systems
4.6.2.5 Magnetic Field-Assisted Systems
4.6.2.6 Nanocarriers
4.6.3 Regional Drug Delivery to the Small Intestine
4.6.3.1 Prodrugs
4.6.3.2 Hydrogels
4.6.3.3 Osmotic Pumps
4.6.3.4 Mucoadhesive Systems
4.6.3.5 Geometrically Modified Dosage Forms
4.6.3.6 Nanocarriers
4.6.4 Regional Drug Delivery to the Colon
4.6.4.1 pH-Responsive Systems
4.6.4.2 Time-Dependent (Delayed-Release) Dosage Forms
4.6.4.3 Osmotically Controlled Systems
4.6.4.4 Biodegradable Formulations
4.6.4.5 Nanocarriers
4.7 Pharmacokinetics
4.8 Products in the Market
References
5. Rectal Novel Drug Delivery Systems
Mahsa Sayed Tabatabaei and Taraneh Gazori
5.1 Introduction
5.2 Anatomy and Physiology
5.3 Barriers to Rectal Drug Delivery
5.3.1 Patient Barrier
5.3.2 Rectal Contents
5.3.3 Time Barrier
5.3.4 Colonic Microbiota
5.3.5 Mucus Layer
5.3.6 Partial First-Pass Effect
5.4 Factors Affecting Rectal Drug Delivery
5.4.1 Physiological Factors
5.4.2 Demographic Factors
5.4.3 Pathological Factors
5.4.4 Pharmaceutical Factors
5.4.5 Physicochemical Factors
5.5 Formulation Considerations
5.6 Challenges and Opportunities of Rectal Drug Delivery
5.7 Classification of Rectal Novel Drug Delivery Systems
5.7.1 Modified Suppositories
5.7.1.1 Geometrically Modified Suppositories
5.7.1.2 Self-Microemulsifiyng Suppositories
5.7.1.3 Coated Suppositories
5.7.1.4 Non-Dissolving Suppositories
5.7.2 Hydrogel-Based Systems
5.7.2.1 Mucoadhesive Hydrogels
5.7.2.2 Thermoresponsive (In situ Forming) Hydrogels
5.7.3 Carrier-Based Systems
5.7.3.1 Lipid-Based Nanocarriers
5.7.3.2 Polymer-Based Carriers
5.7.3.3 Protein-Based Nanoparticles
5.7.3.4 Inorganic-Based Nanoparticles
5.7.4 Carrier-in-Gel Composites
5.7.4.1 Emulgel (Emulsion-in-Gel)
5.7.4.2 Ethosomal Gel (Ethosome-in-Gel)
5.7.4.3 Transfersomal Gel (Trnaferosome-in-Gel)
5.7.4.4 Solid Lipid Nanoparticle Gel (SLN-in-Gel)
5.7.5 Surfactant-Based Liquid Crystalline Gels
5.7.5.1 Niosomal Gel
5.7.5.2 Micelle-Based Suppository
5.8 Pharmacokinetics
5.9 Products in the Market
References
6. Injectable Novel Drug Delivery Systems
Payam Khazaeli and Marzieh SajadiBami
6.1 Introduction
6.2 Anatomy and Physiology
6.3 Parenteral Administration Routes
6.3.1 Intravenous
6.3.1.1 Fast IV Injection
6.3.1.2 Slow IV Infusion
6.3.1.3 Central IV Route
6.3.2 Intramuscular
6.3.2.1 Physiological Variables
6.3.2.2 Formulation
6.3.3 Subcutaneous
6.3.4 Specialized Parenteral Routes
6.4 Classification
6.4.1 Conventional Parenteral Formulations
6.4.1.1 Solutions
6.4.1.2 Suspensions
6.4.1.3 Emulsions
6.4.2 Novel Parenteral Formulations
6.4.2.1 Micro- and Nanocarriers
6.4.2.2 Parenteral Implants
6.4.2.3 In Situ Forming Systems
6.4.2.4 Infusion Devices (Pumps)
6.4.2.5 Injectable Depot Systems
6.5 Formulation Considerations
6.6 Pharmacokinetics
6.7 Products in the Market
References
7. Implantable Drug Delivery Systems
Nasrin Zarei Chamgordani
7.1 Introduction
7.2 Anatomy and Physiology
7.2.1 Subcutaneous
7.2.2 Intrathecal
7.2.3 Vaginal
7.2.4 Intravesicular
7.2.5 Ocular
7.3 Classification and Formulation Considerations
7.3.1 Passive-Release Implantable Systems
7.3.1.1 Polymeric Implantable Drug Delivery Systems
7.3.1.2 Ceramic, Metal, and Metal Alloy Drug Delivery Systems
7.3.1.3 Passive Pumps
7.3.2 Active (Programmable) Release Systems
7.4 Challenges and Opportunities
7.5 Pharmacokinetics
7.5.1 Drug-Eluting Stents
7.5.2 Intrathecal
7.5.3 Subcutaneous
7.6 Products in the Market
References
8. Inhalable Novel Drug Delivery Systems
Mahdieh Farhangi and Fariba Hajifathaliha
8.1 Introduction
8.2 Anatomy and Physiology
8.3 Factors Affecting Pulmonary Drug Delivery
8.3.1 Physiological Factors
8.3.1.1 Mucociliary Clearance
8.3.1.2 Alveolar Macrophages
8.3.1.3 Pulmonary Surfactant Layer
8.3.1.4 Enzymatic Degradation
8.3.2 Pathological Characteristics
8.3.3 Physicochemical Parameters
8.3.3.1 Particle Size
8.3.3.2 Surface Charge
8.3.3.3 Surface Hydrophobicity
8.3.4 Pharmaceutical Parameters
8.3.5 Particles’ Deposition Mechanisms
8.4 Challenges and Opportunities
8.5 Classification and Formulation Considerations
8.5.1 Nanocarriers
8.5.1.1 Polymeric Nanoparticles
8.5.1.2 Liposomes
8.5.1.3 Solid Lipid Nanoparticles and Nanostructured Lipid Carriers
8.5.1.4 Dendrimers
8.5.1.5 Polymeric Micelles
8.5.1.6 Inorganic Nanoparticles
8.5.1.7 Polymer–Drug Conjugates
8.5.2 Formulation Considerations
8.5.3 Template-Assisted Particles
8.5.4 on-Target System
8.6 Pharmacokinetics
8.6.1 A Summary of Pulmonary Pharmacokinetics
8.6.2 Pharmacokinetics of Nanoparticles
8.7 Products in the Market
References
9. Intranasal Novel Drug Delivery Systems
Mehrnoosh Nikpour
9.1 Introduction
9.2 Anatomy and Physiology
9.2.1 Olfaction
9.2.2 Trigeminal Sensation
9.2.3 Immunology
9.2.4 Airflow Dynamics
9.3 Factors Affecting Intranasal Drug Delivery
9.3.1 Physiological Factors
9.3.1.1 Mucus and Mucociliary Clearance (MCC)
9.3.1.2 Enzymatic Cleavages
9.3.1.3 Immunological Parameters
9.3.1.4 Blood Supply
9.3.1.5 Drug Deposition Site
9.3.2 Pathological Situations
9.3.3 Environmental Conditions
9.3.4 Physicochemical Factors
9.3.4.1 Molecular Weight
9.3.4.2 Partition Coefficient and Lipophilicity
9.3.4.3 Aqueous Solubility
9.3.4.4 Dissociation Constant
9.3.5 Pharmaceutical (Formulation-Related) Factors
9.3.6 Administration-Related Factors
9.3.6.1 Pipettes
9.3.6.2 Squeeze Bottles
9.3.6.3 Metered-Dose Inhalers (MDIs)
9.3.6.4 Nebulizers/Atomizers
9.3.6.5 Powder Devices
9.3.6.6 Bioadhesive Formulations
9.4 Challenges and Opportunities
9.5 Classification and Formulation Considerations
9.5.1 Solids
9.5.2 Liquids
9.5.3 Semisolids
9.6 Pharmacokinetics
9.6.1 In Vivo Models
9.6.2 In Vitro Models
9.6.3 Ex Vivo Models
9.7 Products in the Market
References
10. Dermal and Transdermal Novel Drug Delivery Systems
Shiva Hashemi, Saeedeh Abedin, Azadeh Vaezi Moghaddam and Mahsa Sayed Tabatabaei
10.1 Introduction
10.2 Anatomy and Physiology
10.2.1 Epidermis
10.2.1.1 Stratum Corneum
10.2.1.2 Viable Epidermis
10.2.2 Dermis
10.2.3 Hypodermis
10.3 Barriers to Transdermal Drug Delivery
10.4 Factors Affecting Dermal/Transdermal Drug Delivery
10.4.1 Biological Factors
10.4.1.1 Regional Skin Site
10.4.1.2 Skin Metabolism
10.4.1.3 Skin Hydration
10.4.1.4 Skin Temperature
10.4.2 Barrier Function-Related Factors
10.4.3 Demographic Factors
10.4.3.1 Gender
10.4.3.2 Age
10.4.4 Physicochemical Factors
10.4.5 Pharmaceutical Factors
10.5 Challenges and Opportunities
10.6 Classification and Formulation Considerations
10.6.1 Chemical Enhancement Methods
10.6.1.1 Using Chemical Permeation Enhancers
10.6.1.2 Drug Modification
10.6.2 Physical Enhancement Methods
10.6.2.1 Iontophoresis
10.6.2.2 Electroporation
10.6.2.3 Sonophoresis (Phonophoresis)
10.6.2.4 Laser Technology
10.6.2.5 Jet Injection (Needle-Free Injection)
10.6.3 Carrier-Based Systems
10.6.3.1 Lipid-Based Nanocarriers
10.6.3.2 Polymer-Based Nanocarriers
10.6.3.3 Inorganic Nanocarriers
10.6.4 Microneedles
10.6.5 Patches
10.6.6 Metered-Dose Transdermal Sprays (MDTSs)
10.6.7 Advanced Formulations
10.6.7.1 Emulgels
10.6.7.2 Bigels
10.7 Pharmacokinetics
10.7.1 Dermatopharmacokinetic (Tape Stripping) Approach
10.7.2 Microdialysis
10.7.3 Dermal Open-Flow Microperfusion (dOFM)
10.7.4 Vasoconstrictor (Skin Blanching) Assay
10.7.5 Skin Absorption Kinetics
10.8 Products in the Market
References
11. Ocular Novel Drug Delivery Systems
Payam Khazaeli, Mahsa Sayed Tabatabaei, Leila Sayed-Tabatabaei and Mohammad Amin Raeisi Estabragh
11.1 Introduction
11.2 Anatomy and Physiology
11.3 Barriers to Ocular Drug Delivery
11.3.1 Static Barriers
11.3.1.1 Tear Film Barrier
11.3.1.2 Corneal Barrier
11.3.1.3 Conjunctival and Scleral Barriers
11.3.1.4 Blood-Aqueous Barrier
11.3.1.5 Blood-Retinal Barrier
11.3.1.6 Vitreous Barrier
11.3.2 Dynamic Barriers
11.3.2.1 Time Barriers
11.3.2.2 Flow Barriers
11.3.2.3 Efflux Pumps
11.3.2.4 Metabolic (Enzyme) Barrier
11.4 Challenges and Opportunities
11.5 Formulation Considerations
11.5.1 Physicochemical Properties of Drug Molecules
11.5.2 Physicochemical Properties of Nanocarriers
11.5.3 Formulation-Related Factors
11.6 Classification
11.6.1 Ocular Drug Delivery Devices
11.6.1.1 Implants
11.6.1.2 Microneedles
11.6.1.3 Microcannulation or Microcatheters
11.6.1.4 Drug-Eluting Lenses
11.6.1.5 Inserts
11.6.2 Hydrogels and In Situ Gels
11.6.3 Nanocarriers
11.6.4 Viral Vectors
11.6.5 Absorption Enhancement Methods
11.6.6 Prodrugs and Ion Pairs
11.7 Pharmacokinetics
11.8 Products in the Market
References
12. Vaginal Novel Drug Delivery Systems
Yasaman Khajeamiri and Solmaz Ghaffari
12.1 Introduction
12.2 Anatomy and Physiology
12.3 Barriers to Vaginal Drug Delivery
12.3.1 Fluid Flow
12.3.2 pH Barrier
12.3.3 Mucus Barrier
12.3.4 Enzymatic Barrier
12.3.5 Epithelial Barrier
12.3.6 Immune Barrier
12.4 Formulation Considerations
12.4.1 Physicochemical Properties of Drug Molecules
12.4.2 Physicochemical Properties of Nanocarriers
12.4.3 Formulation-Related Factors
12.5 Classification
12.5.1 Solid Dosage Forms and Devices
12.5.1.1 Vaginal Tablets (Pills)
12.5.1.2 Vaginal Capsules
12.5.1.3 Vaginal Powders
12.5.1.4 Vaginal Suppositories
12.5.1.5 Vaginal Films
12.5.1.6 Vaginal Rings
12.5.1.7 Vaginal Tampons
12.5.1.8 Vaginal Sponges
12.5.1.9 Vaginal Microneedle Patches
12.5.2 Semisolid Dosage Forms
12.5.2.1 Liquid Crystal Gels
12.5.2.2 Emulgel (Emulsion-in-Gel)
12.5.2.3 Liposomal Gel
12.5.2.4 Solid Lipid Nanoparticle (SLN) Gel
12.5.2.5 Nanostructured Lipid Carrier (NLC) Gel
12.5.2.6 Niosomal Gels
12.5.2.7 Ethosomal Gels
12.5.2.8 Transfersomal Gels
12.5.3 Liquid Dosage Forms
12.6 Pharmacokinetics
12.7 Products in the Market
References
13. Future of Novel Drug Delivery Systems
Mehrdad Hamidi, Mehraneh Kermanian and Masoumeh Kurd
13.1 Introduction
13.2 Drug Delivery Challenges to be Overcome in the Future
13.2.1 Drug Delivery Barriers
13.2.2 Burst Release
13.2.3 Real-Time Monitoring Issues
13.2.4 High Interindividual Variations
13.2.4.1 Personalized Controlled-Release
13.2.4.2 Personalized System Design
13.2.5 High Cost of Novel Systems
13.2.6 Low Patient Compliance
13.3 Drug Delivery Opportunities to be Seized in the Future
13.3.1 Artificial Intelligence
13.3.2 Novel Techniques
13.3.2.1 Microfluidic
13.3.2.2 3D Printing
13.3.3 New Visions in Biology
13.3.4 New Therapeutic Agents, Protocols, and Strategies
13.3.4.1 Biopharmaceuticals
13.3.4.2 Combinatory Drug Delivery Systems
13.3.4.3 Theranostics
13.3.4.4 Bio-Inspired Drug Delivery Systems
13.3.5 Emerging Technologies
13.3.6 Interdisciplinary Development
13.4 Concluding Remarks
Index
Back to Top
Preface
1. Introduction to Novel Drug Delivery Systems
Mehrdad Hamidi, Mahsa Sayed Tabatabaei, Mohammad Moslehi and Maedeh Barati
1.1 Historical Background
1.2 Definition, Terminology, and Taxonomy
1.3 Novel Drug Delivery Systems: Why, How, and What to Deliver?
1.3.1 Why Delivery?
1.3.1.1 Liberation
1.3.1.2 Absorption
1.3.1.3 Distribution
1.3.1.4 Metabolism
1.3.1.5 Excretion
1.3.2 How to Deliver?
1.3.2.1 Drug Delivery Barriers
1.3.2.2 Overcoming Strategies
1.3.2.3 Designing Criteria of NDDSs
1.3.3 What to Deliver?
1.3.3.1 Small Molecules
1.3.3.2 Biopharmaceuticals
References
2. Novel Drug Delivery Systems: Approach to the Market
Maryam Motamedi and Mahsa Sayed Tabatabaei
2.1 Introduction
2.2 Novel Drug Delivery Systems Global Market
2.2.1 Macroeconomic Indicators Affecting the Market Growth
2.2.2 Novel Drug Delivery Systems
2.2.3 Key Market Trends
2.2.4 Market Segmentation
2.2.5 Therapeutic Areas
2.2.6 Nanotechnology-Based Formulations
2.2.7 The Importance of Communicating Value
2.3 Emerging Diseases, Emerging Technologies
2.3.1 Demographic Factors
2.3.2 Socioeconomic Grounds
2.3.3 Environmental Reasons
2.3.4 Political Considerations
2.3.5 Technological Aspects
2.4 New Development Areas
2.4.1 Poorly Water-Soluble Drugs
2.4.2 Prodrugs
2.4.3 Biopharmaceuticals
2.4.4 Vaccines
2.4.5 Herbal Drugs
2.4.6 Microcarriers and Nanocarriers
2.4.7 Cell Carriers
2.4.8 Biomimetics
2.4.9 Drug Delivery Devices
2.4.10 Codelivery Systems
2.4.11 Self-Delivery Systems
2.4.12 Smart (Stimuli-Responsive) Systems
2.4.13 Theranostics
2.4.14 Noninvasive Drug Administration Routes
2.4.15 Brain Drug Delivery
2.4.16 Lymphatic Drug Delivery
References
3. Intraoral Novel Drug Delivery Systems
Seyedeh Maryam Mortazavi, Leila Sayed-Tabatabaei, Mahsa Sayed Tabatabaei and Azadeh Vaezi Moghaddam
3.1 Introduction
3.2 Anatomy and Physiology
3.3 Factors Affecting Intraoral Drug Delivery
3.3.1 Salivary Flow
3.3.2 pH of Saliva
3.3.3 Salivary Secretory Disorders, Medications, and Therapeutic Interventions
3.3.4 Smoking
3.3.5 Alcohol Consumption
3.3.6 Residence Time of Formulation
3.4 Challenges and Opportunities
3.5 Classification and Formulation Considerations
3.5.1 Orodispersible Dosage Forms (On the Tongue)
3.5.1.1 Orodispersible Tablets
3.5.1.2 Orodispersible Films
3.5.1.3 Orodispersible Granules
3.5.1.4 Oral Lyophilizates
3.5.1.5 Nanoparticles in Orodispersible Formulations
3.5.2 Sublingual Dosage Forms (Under the Tongue)
3.5.2.1 Sublingual Tablets
3.5.2.2 Sublingual Films or Strips
3.5.2.3 Sublingual Solutions
3.5.2.4 Sublingual Soft Gelatine
3.5.2.5 Nanoparticles in Sublingual Formulations
3.5.3 Buccal Dosage Forms
3.5.3.1 Buccal Tablets
3.5.3.2 Buccal Films/Patches
3.5.3.3 Microneedle Platforms
3.5.3.4 Needle-Free Injectors
3.5.3.5 Buccal Solutions
3.5.3.6 Nanoparticles in Buccal Formulations
3.5.4 Gingival/Periodontal Dosage Forms
3.5.4.1 Gingival/Periodontal Gels
3.5.4.2 Gingival/Periodontal Chips
3.5.4.3 Gingival/Periodontal Rinse Solutions
3.5.4.4 Biodegradable Microspheres and Nanoparticles
3.5.5 Dental Drug Delivery Systems
3.5.5.1 Drug-Eluting Implants and Screws
3.5.5.2 Smart Dental Implants
3.5.5.3 Dental Patches
3.5.5.4 Nanoparticles for Dental Drug Delivery
3.5.6 Soft-Palatal Platforms
3.5.6.1 Soft-Palatal Solutions
3.5.6.2 Soft-Palatal Patches
3.5.7 Translabial Drug Delivery Systems
3.5.8 Intraoral Dosage Forms with Nonspecific Site
3.5.8.1 Chewable Dosage Forms: Pastilles and Tablets
3.5.8.2 Lollipops
3.5.8.3 Lozenges
3.6 Pharmacokinetics
3.7 Products in the Market
References
4. Oral Novel Drug Delivery Systems
Mahsa Sayed Tabatabaei
4.1 Introduction
4.2 Anatomy and Physiology of Gastrointestinal Tract
4.3 Barriers to Oral Drug Delivery
4.3.1 Biochemical (Stability) Barriers
4.3.2 Physical (Permeability) Barriers
4.3.3 Cellular (Epithelial) Barrier
4.3.4 Hepatic First-Pass Metabolism (Metabolic Barrier)
4.4 Factors Affecting Oral Drug Delivery
4.4.1 Physiological Factors
4.4.2 Pathological Conditions
4.4.3 Demographic Characteristics
4.4.4 Physicochemical/Pharmaceutical Parameters
4.5 Challenges and Opportunities of Oral Drug Delivery
4.6 Classification of Oral Novel Drug Delivery Systems
4.6.1 Regional Drug Delivery to the Esophagus
4.6.1.1 EsoCap Technology
4.6.1.2 Other Retentive Devices
4.6.2 Regional Drug Delivery to the Stomach
4.6.2.1 Floating (Low-Density) Gastroretentive Systems
4.6.2.2 Sinking (High-Density) Gastroretentive Systems
4.6.2.3 Expandable (Size-Increasing) Gastroretentive Systems
4.6.2.4 Bio/Mucoadhesive Systems
4.6.2.5 Magnetic Field-Assisted Systems
4.6.2.6 Nanocarriers
4.6.3 Regional Drug Delivery to the Small Intestine
4.6.3.1 Prodrugs
4.6.3.2 Hydrogels
4.6.3.3 Osmotic Pumps
4.6.3.4 Mucoadhesive Systems
4.6.3.5 Geometrically Modified Dosage Forms
4.6.3.6 Nanocarriers
4.6.4 Regional Drug Delivery to the Colon
4.6.4.1 pH-Responsive Systems
4.6.4.2 Time-Dependent (Delayed-Release) Dosage Forms
4.6.4.3 Osmotically Controlled Systems
4.6.4.4 Biodegradable Formulations
4.6.4.5 Nanocarriers
4.7 Pharmacokinetics
4.8 Products in the Market
References
5. Rectal Novel Drug Delivery Systems
Mahsa Sayed Tabatabaei and Taraneh Gazori
5.1 Introduction
5.2 Anatomy and Physiology
5.3 Barriers to Rectal Drug Delivery
5.3.1 Patient Barrier
5.3.2 Rectal Contents
5.3.3 Time Barrier
5.3.4 Colonic Microbiota
5.3.5 Mucus Layer
5.3.6 Partial First-Pass Effect
5.4 Factors Affecting Rectal Drug Delivery
5.4.1 Physiological Factors
5.4.2 Demographic Factors
5.4.3 Pathological Factors
5.4.4 Pharmaceutical Factors
5.4.5 Physicochemical Factors
5.5 Formulation Considerations
5.6 Challenges and Opportunities of Rectal Drug Delivery
5.7 Classification of Rectal Novel Drug Delivery Systems
5.7.1 Modified Suppositories
5.7.1.1 Geometrically Modified Suppositories
5.7.1.2 Self-Microemulsifiyng Suppositories
5.7.1.3 Coated Suppositories
5.7.1.4 Non-Dissolving Suppositories
5.7.2 Hydrogel-Based Systems
5.7.2.1 Mucoadhesive Hydrogels
5.7.2.2 Thermoresponsive (In situ Forming) Hydrogels
5.7.3 Carrier-Based Systems
5.7.3.1 Lipid-Based Nanocarriers
5.7.3.2 Polymer-Based Carriers
5.7.3.3 Protein-Based Nanoparticles
5.7.3.4 Inorganic-Based Nanoparticles
5.7.4 Carrier-in-Gel Composites
5.7.4.1 Emulgel (Emulsion-in-Gel)
5.7.4.2 Ethosomal Gel (Ethosome-in-Gel)
5.7.4.3 Transfersomal Gel (Trnaferosome-in-Gel)
5.7.4.4 Solid Lipid Nanoparticle Gel (SLN-in-Gel)
5.7.5 Surfactant-Based Liquid Crystalline Gels
5.7.5.1 Niosomal Gel
5.7.5.2 Micelle-Based Suppository
5.8 Pharmacokinetics
5.9 Products in the Market
References
6. Injectable Novel Drug Delivery Systems
Payam Khazaeli and Marzieh SajadiBami
6.1 Introduction
6.2 Anatomy and Physiology
6.3 Parenteral Administration Routes
6.3.1 Intravenous
6.3.1.1 Fast IV Injection
6.3.1.2 Slow IV Infusion
6.3.1.3 Central IV Route
6.3.2 Intramuscular
6.3.2.1 Physiological Variables
6.3.2.2 Formulation
6.3.3 Subcutaneous
6.3.4 Specialized Parenteral Routes
6.4 Classification
6.4.1 Conventional Parenteral Formulations
6.4.1.1 Solutions
6.4.1.2 Suspensions
6.4.1.3 Emulsions
6.4.2 Novel Parenteral Formulations
6.4.2.1 Micro- and Nanocarriers
6.4.2.2 Parenteral Implants
6.4.2.3 In Situ Forming Systems
6.4.2.4 Infusion Devices (Pumps)
6.4.2.5 Injectable Depot Systems
6.5 Formulation Considerations
6.6 Pharmacokinetics
6.7 Products in the Market
References
7. Implantable Drug Delivery Systems
Nasrin Zarei Chamgordani
7.1 Introduction
7.2 Anatomy and Physiology
7.2.1 Subcutaneous
7.2.2 Intrathecal
7.2.3 Vaginal
7.2.4 Intravesicular
7.2.5 Ocular
7.3 Classification and Formulation Considerations
7.3.1 Passive-Release Implantable Systems
7.3.1.1 Polymeric Implantable Drug Delivery Systems
7.3.1.2 Ceramic, Metal, and Metal Alloy Drug Delivery Systems
7.3.1.3 Passive Pumps
7.3.2 Active (Programmable) Release Systems
7.4 Challenges and Opportunities
7.5 Pharmacokinetics
7.5.1 Drug-Eluting Stents
7.5.2 Intrathecal
7.5.3 Subcutaneous
7.6 Products in the Market
References
8. Inhalable Novel Drug Delivery Systems
Mahdieh Farhangi and Fariba Hajifathaliha
8.1 Introduction
8.2 Anatomy and Physiology
8.3 Factors Affecting Pulmonary Drug Delivery
8.3.1 Physiological Factors
8.3.1.1 Mucociliary Clearance
8.3.1.2 Alveolar Macrophages
8.3.1.3 Pulmonary Surfactant Layer
8.3.1.4 Enzymatic Degradation
8.3.2 Pathological Characteristics
8.3.3 Physicochemical Parameters
8.3.3.1 Particle Size
8.3.3.2 Surface Charge
8.3.3.3 Surface Hydrophobicity
8.3.4 Pharmaceutical Parameters
8.3.5 Particles’ Deposition Mechanisms
8.4 Challenges and Opportunities
8.5 Classification and Formulation Considerations
8.5.1 Nanocarriers
8.5.1.1 Polymeric Nanoparticles
8.5.1.2 Liposomes
8.5.1.3 Solid Lipid Nanoparticles and Nanostructured Lipid Carriers
8.5.1.4 Dendrimers
8.5.1.5 Polymeric Micelles
8.5.1.6 Inorganic Nanoparticles
8.5.1.7 Polymer–Drug Conjugates
8.5.2 Formulation Considerations
8.5.3 Template-Assisted Particles
8.5.4 on-Target System
8.6 Pharmacokinetics
8.6.1 A Summary of Pulmonary Pharmacokinetics
8.6.2 Pharmacokinetics of Nanoparticles
8.7 Products in the Market
References
9. Intranasal Novel Drug Delivery Systems
Mehrnoosh Nikpour
9.1 Introduction
9.2 Anatomy and Physiology
9.2.1 Olfaction
9.2.2 Trigeminal Sensation
9.2.3 Immunology
9.2.4 Airflow Dynamics
9.3 Factors Affecting Intranasal Drug Delivery
9.3.1 Physiological Factors
9.3.1.1 Mucus and Mucociliary Clearance (MCC)
9.3.1.2 Enzymatic Cleavages
9.3.1.3 Immunological Parameters
9.3.1.4 Blood Supply
9.3.1.5 Drug Deposition Site
9.3.2 Pathological Situations
9.3.3 Environmental Conditions
9.3.4 Physicochemical Factors
9.3.4.1 Molecular Weight
9.3.4.2 Partition Coefficient and Lipophilicity
9.3.4.3 Aqueous Solubility
9.3.4.4 Dissociation Constant
9.3.5 Pharmaceutical (Formulation-Related) Factors
9.3.6 Administration-Related Factors
9.3.6.1 Pipettes
9.3.6.2 Squeeze Bottles
9.3.6.3 Metered-Dose Inhalers (MDIs)
9.3.6.4 Nebulizers/Atomizers
9.3.6.5 Powder Devices
9.3.6.6 Bioadhesive Formulations
9.4 Challenges and Opportunities
9.5 Classification and Formulation Considerations
9.5.1 Solids
9.5.2 Liquids
9.5.3 Semisolids
9.6 Pharmacokinetics
9.6.1 In Vivo Models
9.6.2 In Vitro Models
9.6.3 Ex Vivo Models
9.7 Products in the Market
References
10. Dermal and Transdermal Novel Drug Delivery Systems
Shiva Hashemi, Saeedeh Abedin, Azadeh Vaezi Moghaddam and Mahsa Sayed Tabatabaei
10.1 Introduction
10.2 Anatomy and Physiology
10.2.1 Epidermis
10.2.1.1 Stratum Corneum
10.2.1.2 Viable Epidermis
10.2.2 Dermis
10.2.3 Hypodermis
10.3 Barriers to Transdermal Drug Delivery
10.4 Factors Affecting Dermal/Transdermal Drug Delivery
10.4.1 Biological Factors
10.4.1.1 Regional Skin Site
10.4.1.2 Skin Metabolism
10.4.1.3 Skin Hydration
10.4.1.4 Skin Temperature
10.4.2 Barrier Function-Related Factors
10.4.3 Demographic Factors
10.4.3.1 Gender
10.4.3.2 Age
10.4.4 Physicochemical Factors
10.4.5 Pharmaceutical Factors
10.5 Challenges and Opportunities
10.6 Classification and Formulation Considerations
10.6.1 Chemical Enhancement Methods
10.6.1.1 Using Chemical Permeation Enhancers
10.6.1.2 Drug Modification
10.6.2 Physical Enhancement Methods
10.6.2.1 Iontophoresis
10.6.2.2 Electroporation
10.6.2.3 Sonophoresis (Phonophoresis)
10.6.2.4 Laser Technology
10.6.2.5 Jet Injection (Needle-Free Injection)
10.6.3 Carrier-Based Systems
10.6.3.1 Lipid-Based Nanocarriers
10.6.3.2 Polymer-Based Nanocarriers
10.6.3.3 Inorganic Nanocarriers
10.6.4 Microneedles
10.6.5 Patches
10.6.6 Metered-Dose Transdermal Sprays (MDTSs)
10.6.7 Advanced Formulations
10.6.7.1 Emulgels
10.6.7.2 Bigels
10.7 Pharmacokinetics
10.7.1 Dermatopharmacokinetic (Tape Stripping) Approach
10.7.2 Microdialysis
10.7.3 Dermal Open-Flow Microperfusion (dOFM)
10.7.4 Vasoconstrictor (Skin Blanching) Assay
10.7.5 Skin Absorption Kinetics
10.8 Products in the Market
References
11. Ocular Novel Drug Delivery Systems
Payam Khazaeli, Mahsa Sayed Tabatabaei, Leila Sayed-Tabatabaei and Mohammad Amin Raeisi Estabragh
11.1 Introduction
11.2 Anatomy and Physiology
11.3 Barriers to Ocular Drug Delivery
11.3.1 Static Barriers
11.3.1.1 Tear Film Barrier
11.3.1.2 Corneal Barrier
11.3.1.3 Conjunctival and Scleral Barriers
11.3.1.4 Blood-Aqueous Barrier
11.3.1.5 Blood-Retinal Barrier
11.3.1.6 Vitreous Barrier
11.3.2 Dynamic Barriers
11.3.2.1 Time Barriers
11.3.2.2 Flow Barriers
11.3.2.3 Efflux Pumps
11.3.2.4 Metabolic (Enzyme) Barrier
11.4 Challenges and Opportunities
11.5 Formulation Considerations
11.5.1 Physicochemical Properties of Drug Molecules
11.5.2 Physicochemical Properties of Nanocarriers
11.5.3 Formulation-Related Factors
11.6 Classification
11.6.1 Ocular Drug Delivery Devices
11.6.1.1 Implants
11.6.1.2 Microneedles
11.6.1.3 Microcannulation or Microcatheters
11.6.1.4 Drug-Eluting Lenses
11.6.1.5 Inserts
11.6.2 Hydrogels and In Situ Gels
11.6.3 Nanocarriers
11.6.4 Viral Vectors
11.6.5 Absorption Enhancement Methods
11.6.6 Prodrugs and Ion Pairs
11.7 Pharmacokinetics
11.8 Products in the Market
References
12. Vaginal Novel Drug Delivery Systems
Yasaman Khajeamiri and Solmaz Ghaffari
12.1 Introduction
12.2 Anatomy and Physiology
12.3 Barriers to Vaginal Drug Delivery
12.3.1 Fluid Flow
12.3.2 pH Barrier
12.3.3 Mucus Barrier
12.3.4 Enzymatic Barrier
12.3.5 Epithelial Barrier
12.3.6 Immune Barrier
12.4 Formulation Considerations
12.4.1 Physicochemical Properties of Drug Molecules
12.4.2 Physicochemical Properties of Nanocarriers
12.4.3 Formulation-Related Factors
12.5 Classification
12.5.1 Solid Dosage Forms and Devices
12.5.1.1 Vaginal Tablets (Pills)
12.5.1.2 Vaginal Capsules
12.5.1.3 Vaginal Powders
12.5.1.4 Vaginal Suppositories
12.5.1.5 Vaginal Films
12.5.1.6 Vaginal Rings
12.5.1.7 Vaginal Tampons
12.5.1.8 Vaginal Sponges
12.5.1.9 Vaginal Microneedle Patches
12.5.2 Semisolid Dosage Forms
12.5.2.1 Liquid Crystal Gels
12.5.2.2 Emulgel (Emulsion-in-Gel)
12.5.2.3 Liposomal Gel
12.5.2.4 Solid Lipid Nanoparticle (SLN) Gel
12.5.2.5 Nanostructured Lipid Carrier (NLC) Gel
12.5.2.6 Niosomal Gels
12.5.2.7 Ethosomal Gels
12.5.2.8 Transfersomal Gels
12.5.3 Liquid Dosage Forms
12.6 Pharmacokinetics
12.7 Products in the Market
References
13. Future of Novel Drug Delivery Systems
Mehrdad Hamidi, Mehraneh Kermanian and Masoumeh Kurd
13.1 Introduction
13.2 Drug Delivery Challenges to be Overcome in the Future
13.2.1 Drug Delivery Barriers
13.2.2 Burst Release
13.2.3 Real-Time Monitoring Issues
13.2.4 High Interindividual Variations
13.2.4.1 Personalized Controlled-Release
13.2.4.2 Personalized System Design
13.2.5 High Cost of Novel Systems
13.2.6 Low Patient Compliance
13.3 Drug Delivery Opportunities to be Seized in the Future
13.3.1 Artificial Intelligence
13.3.2 Novel Techniques
13.3.2.1 Microfluidic
13.3.2.2 3D Printing
13.3.3 New Visions in Biology
13.3.4 New Therapeutic Agents, Protocols, and Strategies
13.3.4.1 Biopharmaceuticals
13.3.4.2 Combinatory Drug Delivery Systems
13.3.4.3 Theranostics
13.3.4.4 Bio-Inspired Drug Delivery Systems
13.3.5 Emerging Technologies
13.3.6 Interdisciplinary Development
13.4 Concluding Remarks
Index
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