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E-grāmata: Direct Nose-to-Brain Drug Delivery: Mechanism, Technological Advances, Applications, and Regulatory Updates

Edited by (Professor, Department of Pharmaceutical Technology of the Faculty of Pharmacy, University of Porto, Portugal), Edited by (Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, India)
  • Formāts: PDF+DRM
  • Izdošanas datums: 16-Jun-2021
  • Izdevniecība: Academic Press Inc
  • Valoda: eng
  • ISBN-13: 9780128225233
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  • Formāts: PDF+DRM
  • Izdošanas datums: 16-Jun-2021
  • Izdevniecība: Academic Press Inc
  • Valoda: eng
  • ISBN-13: 9780128225233
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Direct Nose to Brain Drug Delivery: Mechanism, Technological Advances, Applications and Regulatory Updates provides the reader with precise knowledge about the strategies and approaches for enhanced nose to brain drug delivery. It highlights the development of novel nanocarrier-based drug delivery systems for targeted drug delivery to the brain microenvironments with a focus on the technological advances in the development of the novel drug delivery devices for intranasal administration, including special emphasis on brain targeting through nose. This book explores the various quantification parameters to assess the brain targeting efficiency following intranasal administration, includes an overview on the toxicity aspects of the various materials used to develop the direct nose to brain drug delivery vehicles and of the regulatory aspects including patents and current clinical status of the potential neurotherapeutics for the effective management of neuro-ailments. Technological advances in new drug delivery systems with diverse applications in pharmaceutical, biomedical, biomaterials, and biotechnological fields are also explained. Direct Nose to Brain Drug Delivery: Mechanism, Technological Advances, Applications and Regulatory Updates is a crucial source that will assist the veteran scientists, industrial technologists, and clinical research professionals to develop new drug delivery systems, and novel drug administration devices for the treatment of neuro-ailments.
  • Explains the targeting approaches for enhanced brain targeting following intranasal drug administration
  • Explores the various nanocarriers developed to date for neurotherapeutic delivery via nose to brain
  • Discusses pharmaceutical and biomedical applications after nose to brain delivery of therapeutic pharmaceuticals and biologicals
Contributors xiii
About the editors xvii
Foreword xix
Preface xxi
Section I Basic considerations in nose-to-brain drug delivery
1 An overview of anatomical and physiological aspects of the nose and the brain
3(12)
Dignesh Khunt
Manju Misra
1.1 Introduction
3(1)
1.2 Nasal anatomy
4(7)
1.2.1 General considerations
4(1)
1.2.2 External nose
4(2)
1.2.3 Nasal cavities
6(3)
1.2.4 Paranasal sinuses
9(1)
1.2.5 Nasopharynx
9(1)
1.2.6 Junctional complexes
9(2)
1.3 Nasal physiology
11(1)
1.3.1 Olfaction
11(1)
1.3.2 Sensation
11(1)
1.3.3 Immunology
11(1)
1.3.4 Protection
11(1)
1.3.5 Filtration
11(1)
1.3.6 Air conditioning
11(1)
1.3.7 Nasal cycle and airflow dynamics
12(1)
1.3.8 Speech
12(1)
1.4 Transport pathways from the nose to the central nervous system
12(1)
1.4.1 Transport across the olfactory and respiratory epithelial barriers
12(1)
1.4.2 Transport from the nasal lamina propria to the sites of brain entry
12(1)
1.4.3 Transport from brain entry sites to other CNS areas
13(1)
1.5 Conclusion
13(2)
References
13(2)
2 Direct transport theory: From the nose to the brain
15(24)
Namdev Dhas
Dattatray Yadav
Ashutosh Singh
Atul Garkal
Ritu Kudarha
Priyanka Bangar
Jignasa Savjani
Chandrakantsing V. Pardeshi
Neha Garg
Tejal Mehta
2.1 Introduction
16(1)
2.2 Earlier scenario of direct nose-to-brain drug delivery
16(1)
2.3 The in vivo biofate of intranasal neurotherapeutics
17(7)
2.3.1 Absorption
17(5)
2.3.2 Distribution
22(1)
2.3.3 Metabolism
23(1)
2.3.4 Elimination
23(1)
2.4 Pathways for brain targeting after intranasal administration
24(2)
2.4.1 Olfactory nerve pathways
24(1)
2.4.2 Trigeminal nerve pathway (TNP)
25(1)
2.4.3 Rostral migraine stream pathways
25(1)
2.4.4 Vascular pathway
26(1)
2.5 Transport mechanisms
26(4)
2.5.1 Intracellular mechanism
26(3)
2.5.2 Extracellular mechanism
29(1)
2.6 Clinical investigations to prove direct transport theory
30(2)
2.6.1 Benzodiazepines
30(1)
2.6.2 Insulin
31(1)
2.6.3 Angiotensin II
31(1)
2.6.4 Melanocortins
31(1)
2.6.5 Oxytocin
32(1)
2.7 Concluding remark
32(7)
Acknowledgments
32(1)
Conflict of interest
32(1)
References
32(7)
3 Physicochemical, biopharmaceutical, and practical considerations for efficient nose-to-brain drug delivery
39(18)
Umesh D. Laddha
Amol A. Tagalpallewar
3.1 Introduction
39(1)
3.2 Nasal pathways to the brain
40(4)
3.2.1 Nasal structure and functions
40(2)
3.2.2 Naso-brain pathways
42(1)
3.2.3 Biofate of drugs instilled in nasal cavity
43(1)
3.3 Barriers to effective naso-brain drug delivery
44(1)
3.3.1 Poor bioavailability
44(1)
3.3.2 Mucociliary clearance
44(1)
3.3.3 Enzymatic degradation
45(1)
3.4 Considerations in efficient nose-to-brain drug delivery
45(6)
3.4.1 Physicochemical considerations
45(3)
3.4.2 Biopharmaceutical consideration
48(1)
3.4.3 Practical considerations
49(2)
3.5 Conclusion and future outlook
51(6)
References
52(5)
Section II Nanotechnology and naso-brain drug delivery
4 Nanomedicines for CNS therapy: Fundamental aspects
57(16)
Drashti Desai
Bala Prabhakar
Pravin Shende
4.1 Introduction
57(1)
4.2 The nanotechnology timeline
58(1)
4.3 Nanotechnology and nanomedicines
58(4)
4.4 Drawbacks of conventional CNS drug delivery systems
62(2)
4.5 Rationale for the use of CNS nanomedicines
64(2)
4.5.1 Targeting
65(1)
4.5.2 Imaging
66(1)
4.5.3 Therapy
66(1)
4.6 Nose-to-brain delivery of nanomedicines
66(1)
4.7 Designing nanomaterials for nose-to-brain delivery
66(1)
4.8 Role of nano-sized vectors in nose-to-brain drug delivery
67(2)
4.8.1 Solubilization and stabilization
68(1)
4.8.2 Sustained release
68(1)
4.8.3 Enhanced intranasal residence
69(1)
4.9 Nanomedicines: Industrial perspectives
69(1)
4.10 Future of nanomedicines in nose-to-brain drug delivery
70(3)
References
70(3)
5 Nanotechnological advances in direct nose-to-brain drug delivery for neurodegenerative disorders and other neuroailments
73(20)
Rahul Shukla
Ashish Kumar
S.J.S. Flora
5.1 Introduction
73(2)
5.2 Nanotechnology for neuroprotection and neuronal tissue regeneration
75(1)
5.3 Designing nanomaterials for drug delivery to the CNS
76(1)
5.3.1 Types of nanocarriers for drug delivery to CNS
76(1)
5.3.2 Desired features of nanocarriers for nose-to-brain drug delivery
76(1)
5.4 Nanocarriers for direct nose-to-brain drug delivery
76(9)
5.4.1 Nanoparticulate carriers
77(5)
5.4.2 Nanovesicular carriers
82(2)
5.4.3 Nanocrystals and nanogels
84(1)
5.5 Nanotechnology-based therapies for neurodegenerative disorders and other neuroailments
85(2)
5.5.1 Gene therapy
85(1)
5.5.2 Stem cell therapy
86(1)
5.5.3 Immunological therapy
86(1)
5.5.4 Tissue regeneration therapy
87(1)
5.6 Conclusion and future perspectives
87(6)
Acknowledgments
88(1)
Conflict of interest
88(1)
References
88(5)
6 Surface modification of nanocarriers as a strategy to enhance the direct nose-to-brain drug delivery
93(22)
Chandrakantsing V. Pardeshi
Eliana B. Souto
6.1 Introduction
94(1)
6.2 Properties of nanocarriers for nose-to-brain drug delivery
95(1)
6.3 Surface modification of nanomedicines: Drug delivery benefits
96(1)
6.4 Surface-modified nanomedicines for nose-to-brain drug delivery
97(1)
6.1 Chemical ligands for surface modification of nanocarriers
98(10)
6.2 Polymers as mucoadhesive agents for surface modification of nanocarrier
108(1)
6.3 Lipids as surface modifiers
108(2)
6.4 Nano- and neurotoxicity aspects
110(1)
6.5 Future perspectives and concluding remarks
110(5)
References
110(5)
7 Mucoadhesion as a strategy to enhance the direct nose-to-brain drug delivery
115(42)
Mrunal Paul
7.1 Introduction
116(1)
7.2 Necessity for developing mucoadhesive strategy for direct nose-to-brain drug delivery
117(3)
7.2.1 Nasal mucosa
117(1)
7.2.2 Mucus
118(1)
7.2.3 Cilia
118(1)
7.2.4 Nasal mucociliary clearance
119(1)
7.3 Factors affecting nasal mucociliary clearance
120(2)
7.3.1 Physical factor
120(1)
7.3.2 Pharmacological and chemical
120(1)
7.3.3 Pathological factors
121(1)
7.4 Mucoadhesion: Theories and mechanism
122(6)
7.4.1 Stages of mucoadhesion
122(1)
7.4.2 Theories of mucoadhesion
123(2)
7.4.3 Properties affecting mucoadhesion
125(3)
7.5 Assessment of mucoadhesion
128(5)
7.5.1 In vitro methodologies
128(4)
7.5.2 In vivo
132(1)
7.6 Mucoadhesive polymer used for intranasal drug delivery
133(9)
7.6.1 First-generation mucoadhesive materials
133(5)
7.6.2 Second-generation mucoadhesive materials
138(4)
7.7 Modulation of mucoadhesion at nanoscale for direct nose-to-brain drug delivery
142(5)
7.7.1 Drug-loaded mucoadhesive nanoparticle/carrier
143(1)
7.7.2 Nanocarrier loaded into the mucoadhesive polymer
143(1)
7.7.3 Surface-modified nanocarrier
143(4)
7.8 Conclusion and future perspectives
147(10)
Declaration of interest
148(1)
References
148(9)
8 Nanoparticles for direct nose-to-brain drug delivery: Implications of targeting approaches
157(12)
Raju O. Sonawane
Yogeshwar Bachhav
Avinash R. Tekade
Chandrakantsing V. Pardeshi
8.1 Introduction
158(1)
8.2 History of brain targeted drug delivery through the nose
159(1)
8.3 Targeted drug delivery: General aspects
159(2)
8.4 Targeting approaches for enhanced nose-to-brain delivery
161(5)
8.4.1 Introduction
161(1)
8.4.2 Drug targeting approaches
161(5)
8.5 Summary and conclusion
166(3)
References
166(3)
9 Strategies for enhanced direct nose-to-brain drug delivery
169(18)
Yamini Madav
Sarika Wairkar
9.1 Introduction
170(1)
9.2 Nasal pathways to the brain
170(1)
9.3 Strategies for enhanced direct nose-to-brain drug delivery
171(9)
9.3.1 Biological approach
171(2)
9.3.2 Chemical approach
173(2)
9.3.3 Mechanical approach
175(1)
9.3.4 Physical approach
176(1)
9.3.5 Drug delivery approach
177(3)
9.4 Conclusion and future perspectives
180(7)
References
181(6)
Section III Carriers for direct nose-to-brain drug delivery
10 Particulate carriers for nose-to-brain delivery
187(22)
Shiv Bahadur
Kamla Pathak
10.1 Introduction
188(1)
10.2 Microparticles
188(2)
10.2.1 Microspheres
188(2)
10.2.2 Microemulsions
190(1)
10.3 Nanoparticles
190(11)
10.3.1 Polymer-based NPs
191(2)
10.3.2 Lipid-based NPs
193(2)
10.3.3 Peptide surface-modified NPs
195(1)
10.3.4 Polymeric micelles
195(1)
10.3.5 Nanoemulsions
196(1)
10.3.6 Nanogels
197(1)
10.3.7 Dendrimers
198(1)
10.3.8 Carbon-based nanoformulations
199(1)
10.3.9 Nanosuspension and nanocores
200(1)
10.3.10 Miscellaneous
200(1)
10.4 Transport mechanisms
201(1)
10.5 Current scenario and future perspectives
201(1)
10.6 Conclusion
202(7)
References
202(7)
11 Vesicular carriers for direct nose-to-brain drug delivery
209(16)
Prashant K. Deshmukh
Swapnil N. Jain
Pravin O. Patil
Chandrakantsing V. Pardeshi
11.1 Introduction
209(1)
11.2 Vesicular drug delivery systems
210(4)
11.2.1 Merits
210(4)
11.2.2 Demerits
214(1)
11.3 Vesicular carriers for direct nose-to-brain drug delivery
214(5)
11.3.1 Liposomes
214(1)
11.3.2 Niosomes
215(1)
11.3.3 Transferosomes
215(1)
11.3.4 Novasomes
216(1)
11.3.5 Ethosomes
217(1)
11.3.6 Virosomes
217(1)
11.3.7 Cubosomes
218(1)
11.3.8 Emulsomes
219(1)
11.4 Regulatory aspects and clinical translational updates
219(1)
11.5 Conclusion and future perspectives
220(5)
References
220(5)
12 Gel-based delivery of neurotherapeutics via naso-brain pathways
225(24)
Hitendra S. Mahajan
Payal H. Patil
12.1 Introduction
225(1)
12.2 Classification of neurological/brain disorders
226(1)
12.3 Current prevalence spectrum of neurological disorders
226(1)
12.4 Mechanism of gelation
226(7)
12.4.1 Physiological stimuli-based in situ gelation
227(5)
12.4.2 Physical form-based in situ gelation
232(1)
12.4.3 Chemical reaction-based in situ gelation
232(1)
12.5 Gel-based systems for brain drug delivery via intranasal administration
233(9)
12.5.1 Hydrogels
237(1)
12.5.2 In situ gels
237(3)
12.5.3 Biogels
240(1)
12.5.4 Nanogels
241(1)
12.5.5 Transferosomal gels
241(1)
12.5.6 Cubosomal gels
241(1)
12.6 Conclusion and future perspectives
242(7)
References
242(7)
Section IV Applications of direct nose-to-brain delivery
13 Applications of direct nose-to-brain drug delivery in medicine and pharmacy
249(18)
Ganesh B. Shevalkar
Mahendra K. Prajapati
Rohan V. Pai
Kamlesh D. Mali
13.1 Introduction
249(1)
13.2 Potential of intranasal administration in brain targeting
250(1)
13.3 Formulation strategies for direct nose-to-brain delivery
250(9)
13.3.1 Nasal enzyme inhibitors
252(1)
13.3.2 Permeation enhancers
252(1)
13.3.3 Prodrug approach
252(6)
13.3.4 Structural modification
258(1)
13.3.5 Particulate drug delivery
258(1)
13.3.6 Bioadhesive polymers as delivery systems for nose-to-brain delivery
258(1)
13.4 Applications of direct nose-to-brain delivery systems
259(3)
13.4.1 Delivery of small molecules
259(1)
13.4.2 Delivery of macromolecules
259(1)
13.4.3 Delivery of genes
260(1)
13.4.4 Vaccine delivery
261(1)
13.4.5 Tissue engineering
261(1)
13.4.6 Diagnostic applications
262(1)
13.5 Market potential of the direct nose-to-brain delivery system
262(2)
13.6 Conclusion and future perspectives
264(3)
References
264(3)
14 Applications of direct nose-to-brain drug delivery in biomedicine, biotechnology, tissue engineering, and immunology
267(20)
Sanjay B. Patil
14.1 Introduction
268(1)
14.2 Direct nose-to-brain drug delivery in biomedicine
269(5)
14.2.1 Strategies for specific diseases
269(3)
14.2.2 Therapeutic applications
272(2)
14.3 Direct nose-to-brain drug delivery in biotechnology, tissue engineering, and immunology
274(7)
14.3.1 Drug delivery to the brain with antibodies
274(1)
14.3.2 Targeted delivery of neurotrophins
275(2)
14.3.3 siRNA delivery to the brain
277(2)
14.3.4 Cell-based therapies for brain disorders
279(2)
14.4 Concluding remarks
281(6)
References
282(5)
15 Diagnostic and theranostic intranasal nanointerventions for brain diseases
287(18)
Prashant Upadhaya
Sreeranjini Pulakkat
Vandana Patravale
15.1 Introduction
288(1)
15.1.1 The blood-brain barrier (BBB)
288(1)
15.1.2 Intranasal delivery
288(1)
15.2 Intranasal nanodiagnostics and nanotheranostics
288(11)
15.2.1 Intranasal diagnostic and theranostic interventions in neurodegenerative diseases
291(4)
15.2.2 Intranasal diagnostic and theranostic interventions in cancer
295(4)
15.3 Traumatic brain injury
299(1)
15.4 Cerebral ischemia
299(1)
15.5 Conclusion
299(6)
Acknowledgment
300(1)
References
300(5)
16 Nose-to-brain delivery of biologies and stem cells
305(24)
Mukta Agrawal
Aditya Narayan Konwar
Amit Alexander
Vivek Borse
16.1 Introduction
306(1)
16.2 Nasal cavity
307(1)
16.2.1 Anatomy of the nasal cavity
307(1)
16.2.2 Transport across the nasal cavity to the CNS
307(1)
16.3 Barriers and challenges for nose-to-brain delivery of biologies
308(2)
16.3.1 Blood-brain barrier
308(1)
16.3.2 Nasal anatomy
309(1)
16.4 Direct nose-to-brain delivery of biologies
310(8)
16.4.1 Protein/peptide delivery
310(7)
16.4.2 Delivery of gene vectors
317(1)
16.4.3 Delivery of stem cells
317(1)
16.5 Auxiliary tools to improve the nose-to-brain delivery
318(2)
16.5.1 Permeation enhancers
318(1)
16.5.2 Mucolytics
318(1)
16.5.3 Mucoadhesives
319(1)
16.5.4 Gelling agents
319(1)
16.5.5 Enzyme inhibitors
319(1)
16.5.6 Vasoconstrictor
320(1)
16.6 Nasally administered biologies currently on the market
320(1)
16.7 Conclusion and future perspective
320(9)
Acknowledgment
323(1)
References
323(6)
17 Applications of nose-to-brain delivery in nanodiagnosis and nanotherapy of neurodegenerative disorders
329(22)
Abhijeet Kulkarni
Mahesh Shinde
Gaurav Sonawane
Hitesh Raotole
Rohit Pande
Chandrakantsing V. Pardeshi
17.1 Introduction
330(1)
17.2 Nanoparticle-mediated direct nose-to-brain drug delivery
330(3)
17.2.1 Pathways and mechanisms for direct nose-to-brain delivery of nanomaterials
331(1)
17.2.2 Properties of nanomaterials required for direct nose-to-brain drug delivery
331(1)
17.2.3 Transport capabilities of nanomaterials in direct nose-to-brain drug delivery
332(1)
17.3 Neurodegenerative disorders
333(5)
17.3.1 Alzheimer's disease (AD)
334(1)
17.3.2 Parkinson's disease (PD)
335(1)
17.3.3 Huntington's disease (HD)
335(2)
17.3.4 Prion disease (PrD)
337(1)
17.3.5 Amyotrophic lateral sclerosis (ALS)
337(1)
17.3.6 Multiple sclerosis (MS)
338(1)
17.3.7 Frontotemporal dementia (FTD)
338(1)
17.4 Diagnosis of neurodegenerative disorders
338(2)
17.5 Nanobiosensors for rapid detection of neurodegenerative disorders
340(1)
17.6 Advanced nanotherapeutics approaches for direct nose-to-brain delivery in neurodegenerative disorders
341(3)
17.6.1 Nanotherapeutic strategies for the treatment of AD
341(1)
17.6.2 Nanotherapeutic strategies for the treatment of PD
341(3)
17.6.3 Nanotherapeutic strategies for the treatment of other NDs
344(1)
17.7 Nanotherapy for neuroprotection and neuronal tissue regeneration
344(1)
17.7.1 Neuroprotection
344(1)
17.7.2 Neuronal tissue regeneration
344(1)
17.8 Concluding remarks
344(7)
References
345(6)
18 Intranasal gene therapy for the treatment of neurological disorders
351(38)
Namdev Dhas
Tejal Mehta
Shilpa Sharma
Atul Garkal
Dattatray Yaday
Kartik Hariharan
Babeeta Shamjetshabam
Shubham Khot
Ritu Kudarha
Priyanka Bangar
Gajanan Arbade
Pratap Kalyankar
18.1 Introduction
352(5)
18.1.1 Neurological disorders
352(3)
18.1.2 Neurovascular diseases
355(1)
18.1.3 Traumatic disorders
356(1)
18.1.4 Gene therapy for neuronal and brain disorders
356(1)
18.2 Current approaches for the treatment of neurological disorders
357(3)
18.2.1 Alzheimer's disease
357(2)
18.2.2 Parkinson's disease
359(1)
18.2.3 Epilepsy
360(1)
18.3 Challenges for gene delivery to CNS
360(2)
18.4 Intranasal route
362(1)
18.4.1 Anatomy
362(1)
18.5 Gene delivery modalities
363(3)
18.5.1 Gene augmentation
364(1)
18.5.2 Gene silencing
365(1)
18.5.3 Gene editing
366(1)
18.6 Ideal properties of nanomaterials for gene delivery
366(4)
18.6.1 Types of nanomaterials
367(2)
18.6.2 Function of nanomaterials
369(1)
18.6.3 Factors affecting gene transportation via intranasal nanomaterials
370(1)
18.7 Strategies for gene therapy
370(3)
18.8 Approaches of gene therapy
373(3)
18.8.1 Vehicles for gene therapy
373(2)
18.8.2 Nonviral vectors
375(1)
18.9 Translational medicines
376(2)
18.9.1 Gene therapy for neurodegenerative diseases
377(1)
18.9.2 Cell-based therapies for neurodegenerative diseases
378(1)
18.10 Concluding remark
378(11)
Acknowledgment
379(1)
Conflict of interest
379(1)
References
379(10)
19 Potential of naso-brain drug delivery in glioblastoma therapy
389(16)
Amarjitsing Rajput
Nikunj Tandel
Swapnil Borse
Shital Butani
19.1 Introduction: Glioblastoma---A brain tumor and its pathophysiology
390(3)
19.1.1 Therapeutic intervention: Drug delivery to brain system
390(1)
19.1.2 Intranasal delivery: A novel approach of delivery system
390(3)
19.2 Glioblastoma treatment: Current and nanocarrier-based approaches
393(6)
19.2.1 Nanoparticle mechanism through nasal delivery
394(1)
19.2.2 Solid lipid nanoparticles (SLNs)
394(1)
19.2.3 Nanostructured lipid carriers (NLCs)
395(1)
19.2.4 Polymeric Nanoparticles
395(1)
19.2.5 Vesicular drug delivery system
396(1)
19.2.6 Emulsion
397(2)
19.2.7 Nasya therapy: An Ayurveda-based approach
399(1)
19.3 Future trend for the treatment of glioblastoma
399(6)
Acknowledgments
400(1)
Conflicts of interest
400(1)
References
400(5)
20 Nose-to-brain delivery of antiretroviral drugs against NeuroAIDS
405(12)
Kailas K. Moravkar
Devanshi S. Shah
Durgesh K. Jha
Purnima D. Amin
Sanjay J. Surana
20.1 Introduction
405(1)
20.2 Neurotropic effects of HIV infection
406(1)
20.3 HIV-induced neuropathogenesis in NeuroAIDS
406(2)
20.4 Blood-brain barrier and active efflux transporters in NeuroAIDS
408(1)
20.5 Intranasal delivery of ARVS to target brain
408(1)
20.6 Nanotechnology-based approaches for intranasal administration of antiretroviral drugs for NeuroAIDS
409(3)
20.6.1 Polymeric NPs
409(1)
20.6.2 Lipidic nanosystems
410(1)
20.6.3 Micellar nanosystems
411(1)
20.6.4 Nanoemulsions and microemulsions
411(1)
20.6.5 Miscellaneous
412(1)
20.7 Conclusion
412(5)
References
413(4)
Section V Technological advances for effective drug administration
21 A technology overview on advanced drug administration devices for effective nose-to-brain delivery
417(14)
Sadhana R. Shahi
Chandrakantsing V. Pardeshi
21.1 Introduction
417(1)
21.2 Anatomical and physiological obstructions hampering drug delivery to nose
418(1)
21.2.1 Nasal valve and aerodynamics
418(1)
21.2.2 Nasal cycle
418(1)
21.2.3 Filtration and clearance
419(1)
21.2.4 Nasal-sinus vasculature and lymphatic system
419(1)
21.2.5 Sensitivity of nasal mucosa
419(1)
21.2.6 Enzymatic degradation in the nasal cavity
419(1)
21.3 Advanced drug delivery devices for brain drug delivery via intranasal administration: Technology overview
419(5)
21.3.1 Onzetra® Xsail®
420(1)
21.3.2 Pressurized olfactory device (POD™)
421(1)
21.3.3 ViaNase™
421(1)
21.3.4 Zomig®
422(1)
21.3.5 Naltos™
422(1)
21.3.6 OptiNose®
423(1)
21.3.7 Spravato®
423(1)
21.3.8 ArcherFish™
424(1)
21.4 Assessment of nasal drug delivery devices
424(2)
21.4.1 Estimation of single actuation content (SAC)
424(1)
21.4.2 Determination of size distribution
424(1)
21.4.3 Estimation of particle/droplet size using impactors
425(1)
21.4.4 Assessment of spray pattern and plume geometry
425(1)
21.4.5 Assessment of deposition profiles using nasal casts
425(1)
21.5 Patents on nasal drug delivery devices
426(1)
21.6 Conclusion and future outlook
426(5)
References
426(5)
Section VI Evaluation of direct nose-to-brain drug delivery
22 Experimental models for evaluation of direct nose-to-brain drug delivery
431(28)
Vinit V. Agnihotri
Ashish P. Gorle
Chandrakantsing V. Pardeshi
Sanjay J. Surana
22.1 Introduction
431(1)
22.2 Models for evaluation of direct nose-to-brain drug delivery
432(17)
22.2.1 In vitro models
432(3)
22.2.2 Ex vivo models
435(1)
22.2.3 In vivo models
436(7)
22.2.4 Genetic models
443(3)
22.2.5 Neurotoxic models
446(2)
22.2.6 Computational approaches
448(1)
22.3 Summary and conclusion
449(10)
References
449(7)
Further reading
456(3)
23 Quantitative and qualitative analysis of direct nose-to-brain drug delivery
459(26)
Veena S. Belgamwar
Vidyadevi T. Bhoyar
Sagar Trivedi
Chandrakantsing V. Pardeshi
23.1 Introduction
460(1)
23.2 Calculation of drug dose for nose-to-brain delivery
460(2)
23.3 Analysis of drug following nose-to-brain delivery
462(14)
23.3.1 Quantitative analysis
462(4)
23.3.2 Qualitative analysis
466(10)
23.4 Compartmental pharmacokinetic modeling
476(2)
23.5 Concluding remarks
478(7)
References
478(7)
Section VII Toxicity and regulatory aspects
24 Toxicity aspects: Crucial obstacles to clinical translation of nanomedicines
485(10)
Vikas Bansal
Sameer S. Katiyar
Chander Parkash Dora
24.1 Introduction
485(2)
24.2 Challenges of nanocarriers in clinical translation
487(1)
24.3 Mechanistic aspects of toxicity
488(1)
24.3.1 Basic mechanism of nanotoxicity
489(1)
24.4 Biocompatibility/safety assessment
489(1)
24.5 Strategies to overcome toxicity and paving the way for commercialization
490(1)
24.6 Conclusion
491(4)
References
491(4)
25 Nose-to-brain drug delivery: Regulatory aspects, clinical trials, patents, and future perspectives
495(28)
Abhijeet Pandey
Ajinkya Nikam
Shreya Basavraj
Sadhana Mutalik
Divya Gopalan
Sanjay Kulkarni
Bharat Padya
Gasper Fernandes
Srinivas Mutalik
25.1 Introduction
495(1)
25.2 Policies/role of regulatory agencies in intranasal drug delivery
496(2)
25.2.1 Role of regulatory agency in implementing QbD aspects of nanomedicine in intranasal dosage form development
497(1)
25.3 Marketed nasal products for brain disorder or disease
498(1)
25.4 Patents on nasal products for brain disorder/diseases
498(12)
25.4.1 Patents on nanoformulations for IN delivery to brain
499(11)
25.4.2 Patents on nasal drug delivery devices
510(1)
25.5 Current status of clinical trials
510(6)
25.6 Conclusion and future prospective
516(7)
References
517(6)
Index 523
Dr. Chandrakantsing Pardeshi holds PhD degree in Pharmaceutical Sciences from Kavayitri Bahinabai Chaudhari North Maharashtra University (KBC NMU, India). Presently, he is an Associate Professor of Pharmaceutics at R. C. Patel Institute of Pharmaceutical Education and Research (Shirpur, India) where he is inventing the novel devices for direct nose-to-brain drug delivery. Dr. Pardeshi has authored more than 50 peer-reviewed publications, 21 book chapters and several research abstracts. He has, to his credit, 2 Indian patents and 1 research project funded by University Grants Commission (New Delhi, India). He is an active referee and editorial board member of few reputed multidisciplinary international journals. Dr. Pardeshi also contributed as a Grant evaluator in Government Funding bodies. He has been awarded with Gold Medal from KBC NMU (India), and Excellence Award from Indian Drug Manufacturers Association (IDMA, India). Eliana B. Souto is Habil. Professor from the Department of Pharmaceutical Technology of the Faculty of Pharmacy of University of Porto. Prof. Souto graduated in Pharmaceutical Sciences from University of Coimbra (2000), is holder of a masters in science degree in Pharmaceutical Technology from University of Porto (2002), and PhD in Pharmaceutical Nanotechnology and Biopharmaceutics from the Institut fuer Pharmazie der Freie Universitaet Berlin, Germany (2005). Her research lines include the design, development, and characterization of new drug delivery systems to overcome biological barriers. Prof. Souto serves as Associate Editor, member of the Editorial Board, and Reviewer of several international scientific journals and has published more than 500 works (original and review papers, books and book chapters) in the field of nanosciences and nanomedicine. Prof. Souto also acts as independent expert for several national, European and international funding agencies, and as consultant for pharmaceutical industry.
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