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Oral Delivery of Therapeutic Peptides and Proteins
- 1st Edition - August 18, 2022
- Editors: Puneet Tyagi, Anand Subramony
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 1 0 6 1 - 1
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 2 1 0 6 0 - 4
Oral Delivery of Therapeutic Peptides and Proteins provides a complete overview of the journey scientists pursue to attain protein and peptide oral delivery. The book highlight… Read more
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Request a sales quoteOral Delivery of Therapeutic Peptides and Proteins provides a complete overview of the journey scientists pursue to attain protein and peptide oral delivery. The book highlights the physiological challenges that must be accounted for in addition to overcoming protease inhibition and acid stability issues that are commonly mentioned in this area of research. Primary topics include formulation technologies being adopted for oral delivery of proteins and peptides, modification of actives to make them more suited for oral delivery, animal models and their shortcomings in assessing oral bioavailability, and in vitro models to simulate drug absorption and transport.
Academics and industry researchers working in formulation development and researchers and advanced students in biotechnology and pharmacy will find this a useful resource.
- Demonstrates how proteins and peptides transport throughout the gastrointestinal tract and how to evaluate their biological fate when encapsulated into certain delivery systems
- Examines developing technologies to improve future oral bioavailability
- Includes the in vitro and preclinical techniques needed for development
- Cover image
- Title page
- Table of Contents
- Copyright
- List of contributors
- About the editors
- Foreword
- Preface
- Acknowledgments
- Chapter one. Landscape for oral delivery of peptides
- Abstract
- 1.1 Introduction
- 1.2 Barriers to oral delivery of peptides
- 1.3 Strategies to improve the oral bioavailability of peptides
- 1.4 Progress versus an oral peptide target product profile
- Acknowledgments
- References
- Chapter two. Design and synthesis of chemically modified peptides and proteins —critical considerations for oral delivery
- Abstract
- 2.1 Introduction
- 2.2 Enzymatic barriers to absorption of intact peptides and proteins
- 2.3 Overcoming renal clearance of unmodified peptides
- 2.4 Peptide design considerations to improve oral bioavailability
- 2.5 Rybelsus, an oral semaglutide formulation, a short case study
- 2.6 Conclusions
- References
- Chapter Three. A biopharmaceutics perspective on oral peptide developability and drug delivery
- Abstract
- 3.1 Introduction
- 3.2 Lessons learned from small molecule developability
- 3.3 Barriers to oral peptide delivery
- 3.4 Chemistry approaches to oral peptide developability
- 3.5 Formulation approaches for peptide developability
- 3.6 In silico and in vitro models
- 3.7 Outlook
- Acknowledgments
- References
- Chapter four. Nanoparticle-assisted oral delivery of small and large peptides
- Abstract
- 4.1 Introduction
- 4.2 Insulin
- 4.3 Cyclosporine
- 4.4 Calcitonin
- 4.5 Exenatide
- 4.6 Future perspectives
- Acknowledgments
- References
- Chapter five. Novel formulation approaches for gastrointestinal targeting: characterization and animal model considerations
- Abstract
- 5.1 Introduction
- 5.2 Oral route and human gastrointestinal anatomy (general physiological considerations for colonic drug delivery)
- 5.3 Formulation strategies for colon-targeted drug delivery
- 5.4 Animal models for targeted oral formulations
- 5.5 Conclusion
- References
- Chapter six. CMC Considerations for conventional oral peptide formulations. Scale up and validation
- Abstract
- 6.1 Introduction
- 6.2 Chemistry, manufacturing, and controls
- 6.3 Typical challenges in chemistry, manufacturing, and controls
- References
- Chapter seven. Clinical translation of oral peptide delivery technologies
- Abstract
- 7.1 Introduction
- 7.2 Clinically translated oral peptides
- 7.3 Potential reasons for variable bioavailability in translational studies
- 7.4 Future directions
- References
- Chapter eight. Regulatory aspects of oral peptide delivery
- Abstract
- 8.1 Basis of regulation and regulatory framework
- 8.2 Investigational studies under an IND
- 8.3 Pre-IND meeting
- 8.4 Investigational new drug application
- 8.5 Chemistry, manufacturing, and controls regulatory requirements
- 8.6 Nonclinical requirements
- 8.7 Pharmacology
- 8.8 Pharmacokinetics
- 8.9 Toxicology
- 8.10 Clinical requirements
- 8.11 Drug–drug interactions
- 8.12 Immunogenicity
- 8.13 Regulatory affairs
- 8.14 Regulatory meetings
- 8.15 Marketing authorization
- 8.16 Pre-NDA meeting
- 8.17 NDA/MAA submission
- 8.18 Drug–drug interactions
- 8.19 Immunogenicity
- References
- Index
- No. of pages: 316
- Language: English
- Edition: 1
- Published: August 18, 2022
- Imprint: Academic Press
- Paperback ISBN: 9780128210611
- eBook ISBN: 9780128210604
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Puneet Tyagi
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