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E-raamat: SPEC - Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects, 12-Month Access, eBook: SPEC - Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects, 12-Month Access, eBook

Edited by (School of Pharmacy, Queen's University Belfast, Medical Biology Centre, Belfast, UK), Edited by (School of Pharmacy, Queen's University Belfast), Edited by (School of Pharmacy, Queen's University Belfast, Medical Biology Centre, Belfast, Northern Ireland)
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Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects offers a comprehensive overview of the technical, clinical, regulatory and industrial perspectives on these drug delivery systems. The book follows a sequential order, beginning with the current technical state-of-the-field and moving on to more clinical, industrial and regulatory topics. Opening chapters describe the current needs and potential applications of implantable and long-acting therapeutic approaches. The book goes on to describe established and novel long-acting systems, with a focus on the materials used to prepare these systems and their biocompatibility.

Importantly, applied topics such as scale-up manufacturing, products under clinical trials and regulatory aspects are covered, offering the reader a holistic view of this rapidly growing field.

  • Brings together technical, clinical, regulatory and industrial perspectives for a complete overview of long acting and implantable drug delivery systems
  • Provides up-to-date coverage of established and novel long-acting and implantable drug delivery systems, both in development and actively in use
  • Appeals to a broad readership, including materials scientists, pharmaceutical scientists, biomedical engineers, clinicians and regulatory experts
List of contributors
xiii
Preface xvii
1 Overview of the clinical current needs and potential applications for long-acting and implantable delivery systems
1(16)
Eneko Larraneta
Thakur Raghu Raj Singh
Ryan F. Donnelly
1.1 Introduction
1(2)
1.2 LADDS versus conventional routes for drug administration
3(2)
1.3 Current applications of long-acting drug delivery system
5(4)
1.3.1 Contraception
5(1)
1.3.2 Cancer
5(3)
1.3.3 Ocular diseases
8(1)
1.3.4 Chronic conditions and other applications
8(1)
1.4 Future applications of long-acting drug delivery system
9(8)
References
12(5)
2 Classification, material types, and design approaches of long-acting and implantable drug delivery systems
17(44)
Emilia Utomo
Sarah A. Stewart
Camila J. Picco
Juan Domihguez-Robles
Eneko Larraneta
2.1 Introduction
17(2)
2.2 Implantable polymeric drug delivery device classification
19(3)
2.2.1 Solid implants
19(1)
2.2.2 Injectable long-acting formulations
20(2)
2.3 Mechanism of drug release from implantable and long-acting drug delivery systems
22(4)
2.3.1 Mechanism of drug release from solid implants
22(2)
2.3.2 Mechanism of release from nano/microparticulate injectable formulations
24(1)
2.3.3 Mechanism of release from in situ forming implants
25(1)
2.4 Materials used for implantable and long-acting drug delivery systems manufacturing
26(14)
2.4.1 Materials used for solid implant manufacturing
26(10)
2.4.2 Materials used to prepare injectable long-acting formulations
36(4)
2.5 Manufacturing methods of implants and long-acting formulations
40(6)
2.5.1 Manufacturing of solid implants
40(3)
2.5.2 Methods to prepare in situ forming injectable implants
43(3)
2.6 Implantable polymeric device design
46(1)
2.7 Conclusions
47(14)
References
48(13)
3 Long-acting drug delivery systems for ocular therapies
61(22)
David Waite
Fans M. Adrianto
Febri Annuyanti
Yin So
Wenrui Zhang
Sangdi Wang
Yu Wu
Yujing Wang
Thakur Raghu Raj Singh
3.1 Introduction
61(1)
3.2 Contact lenses and other ocular inserts on the surface as long-acting systems
62(1)
3.3 Long-acting systems for the anterior segment
63(2)
3.4 Periocular delivery of long-acting systems
65(2)
3.5 Long-acting intravitreal systems
67(1)
3.6 Long-acting micro/nanoparticulate delivery systems
68(6)
3.7 In situ forming long-acting implants for ocular delivery
74(1)
3.8 Conclusion and future directions
75(8)
References
76(7)
4 Applications of long-lasting and implantable drug delivery systems for cardiovascular disease treatment
83(46)
Roxanne Khalaj
Dennis Douroumis
4.1 Introduction: Cardiovascular disease and atherosclerosis
83(1)
4.2 Pathophysiology of atherosclerosis
84(3)
4.3 Treatments for atherosclerosis
87(1)
4.4 Stenting
87(4)
4.5 Future directions in stent development
91(2)
4.6 3D printing
93(3)
4.7 Stents manufactured via selective laser sintering
96(4)
4.8 Stents manufactured via MJ
100(1)
4.9 Stents manufactured via stereolithography
101(12)
4.10 Two-photon polymerization
113(2)
4.11 Targeted treatments for other CVDs
115(4)
4.12 Conclusion
119(10)
References
119(10)
5 Implantable and long-lasting drug delivery systems for cancer treatment
129(34)
Catarina Pacheco
Ana Baido
Fldvia Sousa
Bruno Sarmento
5.1 Introduction
129(1)
5.2 Implantable drug delivery systems
130(19)
5.2.1 Nonbiodegradable versus biodegradable implantable drug delivery systems
130(2)
5.2.2 Implantable drug delivery systems applications in cancer treatment
132(17)
5.3 Conclusion
149(14)
Acknowledgments
153(1)
References
153(10)
6 Long-acting drug delivery systems: applications for sexual and reproductive health
163(40)
Sally Galal
Celine Jones
Kevin Coward
6.1 Introduction
163(1)
6.2 Sexual and reproductive health physical and pathological challenges
164(1)
6.3 Different approaches to conquer the physical and pathological obstacles associated with sexual and reproductive health
164(1)
6.4 Drug delivery systems used in the field of sexual and reproductive health
164(18)
6.4.1 Nanomedicine and nanoparticles
165(6)
6.4.2 Exosomes
171(2)
6.4.3 Liposomes
173(3)
6.4.4 Micelles
176(2)
6.4.5 Liquid crystals
178(2)
6.4.6 Polymer gels
180(1)
6.4.7 Sperm-hybrid micromotors for drug delivery in the female reproductive tract
181(1)
6.5 Advances in long-acting contraceptive drug delivery systems
182(3)
6.5.1 Copper-bearing intrauterine devices
183(1)
6.5.2 Levonorgestrel-releasing intrauterine system
184(1)
6.5.3 Progestin-containing subdermal contraceptive implants
184(1)
6.5.4 Effervescent microneedle patch
185(1)
6.6 Advances in long-acting drug delivery systems in AIDS prophylaxis
185(1)
6.7 Conclusion
186(17)
Acknowledgments
187(1)
References
187(16)
7 Long-acting drug delivery systems for schizophrenia treatment
203(20)
Vanteemar S. Sreeraj
Venkataram Shivakumar
Naren P. Rao
Ganesan Venkatasubramanian
7.1 Introduction
203(2)
7.1.1 LAI formulations
204(1)
7.2 Who would benefit from LAI antipsychotics: understanding the indications through mechanism
205(5)
7.2.1 Adherence translates into effectiveness
205(1)
7.2.2 Direct medical supervision enhances the outcome
205(3)
7.2.3 Pharmacokinetics of LAI antipsychotics influencing the clinical decisions
208(1)
7.2.4 Pharmacodynamics: differences in dopamine receptor antagonism
208(1)
7.2.5 LAI antipsychotic may reverse altered receptor sensitivity
209(1)
7.2.6 Neuroplasticity
210(1)
7.3 Special indications
210(1)
7.4 Evidence for superiority of LAI antipsychotic over oral antipsychotics
211(1)
7.5 When to start LAI?
212(1)
7.6 Comparative tolerability of LAI antipsychotics
212(1)
7.7 How to initiate LAI antipsychotic?
213(1)
7.8 Choosing among FGA LAIs and SGA LAIs: newer the better or old is gold?
214(1)
7.9 Clinical utility of LAI antipsychotics: the ground reality
215(1)
7.10 Noninjectable long-acting formulations
216(1)
7.11 Conclusion
216(7)
Acknowledgment
217(1)
Conflict of interest
217(1)
References
217(6)
8 Implantable and long-lasting drug delivery systems for infectious, inflammatory, endocrine, and neurodegenerative diseases
223(26)
Essyrose Mathew
Sarah A. Stewart
Emilia Utomo
Eneko Larraneta
Dimitrios A. Lamprou
8.1 Introduction
223(1)
8.2 Implantable and long-lasting drug delivery systems for infectious diseases
223(7)
8.2.1 Tuberculosis
224(3)
8.2.2 Malaria
227(1)
8.2.3 Hepatitis B
228(2)
8.3 Implantable and long-lasting drug delivery systems for inflammatory diseases
230(4)
8.3.1 Osteoarthritis
231(1)
8.3.2 Long-acting delivery of NSAID drugs
232(2)
8.3.3 Long-acting delivery of steroid drugs
234(1)
8.4 Implantable and long-lasting drug delivery systems for endocrine diseases
234(5)
8.4.1 Hypothyroidism
236(1)
8.4.2 Growth hormone
237(2)
8.5 Implantable and long-lasting drug delivery systems for neurodegenerative diseases
239(10)
References
243(6)
9 Long-lasting drug delivery systems based on microneedles
249(40)
Lalitkumar K. Vora
Kurds Moffatt
Ryan F. Donnelly
9.1 Introduction
249(1)
9.2 Microneedle array patch as a long-acting drug delivery tool
250(5)
9.2.1 Type of microneedle array patch formulations
251(4)
9.3 Long-acting microneedle array patch formulations
255(8)
9.3.1 Microneedle array patches formulation methodologies for long-acting delivery
255(8)
9.4 Application of microneedle array patches for long-acting drug delivery
263(9)
9.4.1 Vaccine
264(1)
9.4.2 Lymphatic targeting
265(2)
9.4.3 HIV infection
267(1)
9.4.4 Contraceptives
268(1)
9.4.5 Antipsychotics
269(1)
9.4.6 Insulin
269(2)
9.4.7 Skin diseases
271(1)
9.5 Laboratory to large-scale considerations
272(2)
9.6 Conclusion and future prospects of microneedle array patch
274(15)
References
275(14)
10 Safety, biodegradability, and biocompatibility considerations of long-acting drug delivery systems
289(30)
Deepakkumar Mishra
Katie Glover
Shilpa Gade
Rahul Sonawane
Thakur Raghu Raj Singh
10.1 Introduction
289(1)
10.2 Biodegradation as per international regulatory bodies
289(6)
10.2.1 Experimental design consideration for the fabrication of biodegradable implants
290(1)
10.2.2 Initial quantification of implants before degradation studies
290(2)
10.2.3 Preparation of biodegradation medium
292(1)
10.2.4 Containers
292(1)
10.2.5 Number of samples
292(1)
10.2.6 Experimental procedure
292(1)
10.2.7 Real-time biodegradation
293(2)
10.2.8 Accelerated degradation
295(1)
10.2.9 Final characterization
295(1)
10.3 Methods to study the biodegradation of long-acting implants under in vitro conditions
295(4)
10.3.1 Estimation of physical changes during biodegradation
295(2)
10.3.2 Estimation of mechanical changes during biodegradation
297(1)
10.3.3 Estimation of chemical changes during degradation
297(2)
10.4 Models for prediction of implant degradation
299(2)
10.4.1 Arrhenius equation
299(1)
10.4.2 Weibull model
299(1)
10.4.3 Korsmeyer--Peppas model
300(1)
10.5 Parameters affecting in vitro polymer degradation
301(2)
10.5.1 Temperature
301(1)
10.5.2 Ph
302(1)
10.5.3 Enzymes
302(1)
10.6 Physiological considerations of assessing in vivo degradation
303(2)
10.6.1 Biological factors affecting in vivo degradation
303(2)
10.7 Immunological consideration of long-acting implants
305(7)
10.7.1 Acute inflammatory response
306(1)
10.7.2 Chronic inflammation
307(1)
10.7.3 Foreign body response and fibrous encapsulation
308(1)
10.7.4 Mechanical properties
309(1)
10.7.5 Chemical properties
310(1)
10.7.6 Surface properties
311(1)
10.8 Conclusion
312(7)
References
312(7)
11 Characterization methodologies for long-acting and implantable drug delivery systems
319(28)
Karsten Mdder
11.1 Introduction
319(3)
11.2 Characterization methods for the general physicochemical properties
322(1)
11.3 Characterization of the microenvironment (microviscosity, micropolarity, and microacidity)
323(8)
11.4 Methods for in vivo characterization
331(10)
11.4.1 Electron spin resonance spectroscopy and imaging
331(2)
11.4.2 Nuclear magnetic resonance spectroscopy and imaging
333(3)
11.4.3 Ultrasound imaging
336(1)
11.4.4 Optical imaging (in vivo fluorescence imaging)
337(1)
11.4.5 Photoacoustic imaging
337(3)
11.4.6 Computer tomography (also X-ray imaging)
340(1)
11.5 Summary
341(6)
References
341(6)
12 Challenges for clinical translation of long-acting and implantable drug delivery systems
347(18)
Michael Colvin
Jason Colvin
12.1 Introduction
347(1)
12.2 Combination products
348(1)
12.3 Combination products in the United States
348(8)
12.3.1 Background and history
348(2)
12.3.2 US regulatory center
350(1)
12.3.3 Combination products regulatory process
351(1)
12.3.4 Draft guidance
352(1)
12.3.5 Applicable regulation--the United States
353(3)
12.4 Combination products--EU
356(5)
12.4.1 Background and history
356(1)
12.4.2 Medical Device Regulation
356(1)
12.4.3 Applicable regulations--EU
357(1)
12.4.4 Applicable regulation--EU
358(3)
12.5 Regulation outside the United States and EU
361(1)
12.6 How the United States and EU diverge?
361(1)
12.7 Patients and combination products
362(1)
12.8 Future steps
362(3)
References
363(2)
Index 365
Prof. Eneko Larrañeta holds the Chair in Pharmaceutical Materials Science at the School of Pharmacy, Queen's University Belfast, specialising in drug delivery systems and biomaterials. He earned a BSc in Chemistry and a PhD in Physical Chemistry from the University of Navarra, where his research centred on self-assembled hydrogels. After completing his PhD in 2012, Prof. Larrañeta worked as a research fellow in nanotechnology for drug delivery before joining Queen's University Belfast in 2013 to advance microneedle technology for transdermal drug delivery. His expertise spans hydrogels, nano/microparticles, and microneedle-based systems. Currently, his research focuses on implantable systems for sustained drug release, utilising techniques like melt processing and additive manufacturing. He has published over 100 peer-reviewed papers, edited multiple books, and contributed numerous book chapters. Prof. Larrañeta has secured funding from leading organisations and collaborated widely with pharmaceutical and cosmetics companies. He has been named a Clarivate Highly Cited Researcher and recognised among the top 2% of scientists in his field by Stanford Universitys analysis using Scopus data. He is a Fellow of the UK Higher Education Academy and a member of the Royal Society of Chemistry and the Society for Applied Microbiology.

Dr Thakur obtained his PhD in Drug Delivery from School of Pharmacy, Queens University Belfast (2009), M.Sc in Pharmaceutical Sciences from University Science Malaysia (2006) and B.Pharm from Jawaharlal Nehru Technological University, India (2002). His current research involves the fabrication and design of novel long-acting injectable and implantable drug delivery systems for treating back of the eye disorders. Dr Thakur's ocular drug delivery research has led to the formation of Re-VanaTherapeutics Ltd. He is currently acting as the CSO for Re-Vana. He is Chair for Ocular Delivery (OcD) Focus Groupsupported by the mission of Controlled Release Society (CRS). He has authored over 150 scientific publications, including 52 peer-reviewed research papers, 10 book chapters and 4 textbooks. He has been an invited speaker at a number of national/international meetings. He is currently Editorial Board member of the International Journal of Pharmacy & Pharmacology, Chronicles of Pharmacy and SCIENCEDOMAINinternational, andScientific advisor for Journal of Pharmaceutical Sciences. Professor Ryan Donnelly holds the Chair in Pharmaceutical Technology at the School of Pharmacy, Queens University Belfast, where he is Director of Research. A registered pharmacist, his research is centred on design and characterisation of advanced polymeric drug delivery systems for transdermal and intradermal drug delivery, with a strong emphasis on improving patient outcomes. He is currently developing a range of novel microneedle technologies through independent research, but also in collaboration with several major pharmaceutical companies. His work has attracted more than £30 million in funding and he has authored over 1000 peer-reviewed publications, including 11 patent applications, 7 textbooks, 28 book chapters and approximately 360 full papers. He leads a personal research group of approximately 50 people from 15 different countries and has been an invited speaker at numerous national and international conferences. Professor Donnelly is Europe/Africa Editor of Drug Delivery & Translational Research. He has won the International Association for Pharmaceutical Technology (APV) Research Award for Outstanding Achievements in the Pharmaceutical Sciences (2024), the Royal Pharmaceutical Societys Harrison Medal (2024), the Kydonieus Foundation Transdermal Delivery Award (2024), the European Journal of Pharmaceutics & Biopharmaceutics Most Cited Paper Award (2023), the Drug Delivery & Translational Research Best Paper Award (2023), Visit Belfasts Ambassador Award for Life & Health Sciences (2022), the Academy of Pharmaceutical Sciences Innovative Science Award (2020), Evoniks Resomer Award (2018), the Controlled Release Societys Young Investigator Award (2016), BBSRC Innovator of the Year (2013), the American Association of Pharmaceutical Scientists Pharmaceutical Research Meritorious Manuscript Award (2013 & 2022), the GSK Emerging Scientist Award (2012), the Royal Pharmaceutical Societys Science Award (2011) and the Pharmaceutical Society of Northern Irelands Gold Medal (1999).
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