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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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 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.

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

Puneet Tyagi

Puneet Tyagi is an Associate Director with the Dosage Form Design and Development group at AstraZeneca, based in Maryland, USA. Puneet leads a team of scientists in the area of biologics formulation development, with a focus on long acting formulations, transdermal delivery, and oral delivery of biologics. Puneet received his bachelor’s and master’s degrees in pharmaceutical sciences from India and his PhD from the University of Colorado. Puneet Tyagi is co-inventor of several U.S. and international patents and has published extensively in the field of drug delivery.

Affiliations and expertise

Associate Director, Dosage Form Design and Development, AstraZeneca

Anand Subramony

Anand Subramony is Vice President within the Biologics Engineering group, R&D, at AstraZeneca (AZ) and leads various cross-functional programs and teams in drug delivery and nanomedicine (for targeted delivery, enabling new modalities for genomic medicine, and creating technology platforms). In addition, he provides leadership to AZ’s external innovation initiatives and CoSolve, an AZ open innovation platform that brings compelling technologies to the portfolio. Before serving in his current role, Dr. Subramony headed the Drug Delivery & Device Development group at MedImmune and built an internal team that focused on combination product development for biologics and oral peptide delivery and other novel controlled release technologies for Biologics. One of the early pioneers in digital health technology solutions in pharma, Dr. Subramony led several novel connected health initiatives in the pharma value chain including remote patient monitoring, adaptive therapy, and continuous monitoring with diagnostic sensors, wearables and use of smartphone Apps. In prior roles, he was Principal Fellow and Head of Novel Delivery Technologies at the Novartis Institutes for BioMedical Research (NIBR, Cambridge, MA), Head of the Materials Science group (E-TRANS) at J&J (Alza, Mountain View, CA), and Director of Materials Science & Drug delivery at Dr. Reddy’s Laboratories (Bridgewater, NJ). With his broad experience in pharma biotech, Dr. Subramony brings innovation, scientific rigor, and execution excellence, with a sense of urgency toward drug development to create patient-centric products. Dr. Subramony holds an M.S. degree in Materials Science Engineering (IIT, Bombay) and a Ph.D. degree from Purdue University and was a research scientist at the University of Washington, Seattle. With several refereed publications and patents, he is a Key Opinion Leader for bringing innovations through drug delivery, devices, and digital health.

Affiliations and expertise

Vice President, R&D, AstraZeneca