Mucosal Delivery of Biopharmaceuticals: Biology, Challenges and Strategies

ISBN-13: 9781461495239 / Angielski / Twarda / 2014 / 601 str.

Jose Alberto Goncalves Das Neves; Bruno Filipe Carmelino Cardoso Sarmento

Opis

Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals.​ Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.

Spis treści

.-1. Concepts in Mucosal Immunity and Mucosal Vaccines
.-Simona Gallorini, Derek T. O’Hagan, Barbara C. Baudner

.-2. Mucoadhesion and Characterization of Mucoadhesive Properties
.-Tao Yu, Gavin P. Andrews, David S. Jones

.-3. Mucus as a Barrier for Biopharmaceuticals and Drug Delivery Systems
.-Hongbo Zhang, Mohammed-Ali Shahbazi, Patrick Almeida, Hélder A. Santos

.-4. Epithelial Permeation and Absorption Mechanisms of Biopharmaceuticals
.-Hanne Mørck Nielsen

.-5. Oral Delivery of Biopharmaceuticals
.-Catarina Oliveira Silva, Bruno Sarmento, Catarina Pinto Reis

.-6. Buccal Delivery of Biopharmaceuticals: Vaccines and Allergens
.-Sevda Şenel, Merve Cansız, Michael J. Rathbone

.-7. Pulmonary Delivery of Biopharmaceuticals
.-Fernanda Andrade, Catarina Moura, Bruno Sarmento

.-8. Nasal Delivery of Biopharmaceuticals
.-Eiji Yuba, Kenji Kono

.-9. Ocular Delivery of Biopharmaceuticals
.-Holly Lorentz, Heather Sheardown

.-10. Vaginal Delivery of Biopharmaceuticals
.-José das Neves

.-11. Nanoparticles-in-Microsphere Oral Delivery Systems (NiMOS) for Nucleic Acid Therapy in the Gastrointestinal Tract
.-Shardool Jain, Mansoor Amiji

.-12. Bacteria-Based Vectors for Oral Gene Therapy
.-Yong Bai, Rachael Burchfield, Sangwei Lu, Fenyong Liu

.-13. Self-Assembled Polysaccharide Nanogels for Nasal Delivery of Biopharmaceuticals
.-Tomonori Nochi, Yoshikazu Yuki, Kazunari Akiyoshi, Hiroshi Kiyono

.-14. Pheroid™ Vesicles and Microsponges for Nasal Delivery of Biopharmaceuticals
.-Lissinda H. du Plessis, Awie F. Kotzé

.-15. Delivery Strategies for Developing siRNA-Based Vaginal Microbicides
.-Joseph A Katakowski, Deborah Palliser

.-16. Delivery Strategies for Developing Vaginal DNA Vaccine Combining Cell-Penetrating Peptides and Jet Injection
.-Takanori Kanazawa, Hiroaki Okada

.-17. Vaccine Delivery Systems for Veterinary Immunization
.-Juan M. Irache, Ana I. Camacho, Carlos Gamazo

.-18. Eligen® Technology for Oral Delivery of Proteins and Peptides
.-Sunita Prem Victor, Willi Paul, and Chandra P. Sharma

.-19. The RapidMist™ System for Buccal Delivery of Insulin
.-Meena Bansal, Sanjay Bansal, Rachna Kumria

.-20. The Pharmaceutical Development of rhDNase (Dornase Alpha) for the Treatment of Cystic Fibrosis
.-Steven J. Shire, Thomas M. Scherer

.-21. Development of the Exubera® Insulin Pulmonary Delivery System
.-Cynthia L. Stevenson, David Bennett

.-22. Technosphere®: An Inhalation System for Pulmonary Delivery of Biopharmaceuticals
.-António J. Almeida, Ana Grenha

.-23. ChiSys® as a Chitosan-Based Delivery Platform for Nasal Vaccination
.-Peter Watts, Alan Smith, Michael Hinchcliffe

.-24. Development of a Cationic Nanoemulsion Platform (Novasorb®) for Ocular Delivery
.-Frédéric Lallemand, Philippe Daull, Jean-Sébastien Garrigue

.-25. Regulatory Aspects and Approval of Biopharmaceuticals for Mucosal Delivery: Quality, Toxicology and Clinical Aspects
.-Karen Brigitta Goetz, Yuansheng Sun, Katrin Féchir, Evelyne Kretzschmar, Isabel Buettel

O autorze

José das Neves is a researcher at Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, and in the Faculty of Pharmacy, University of Porto, Portugal, where he earned a Ph.D. in Pharmaceutical Sciences. His previous work has spanned multiple aspects of the development of vaginal drug delivery systems, and his current research interests include the development of nanotechnology-based solutions for the development of anti-HIV microbicides and mucosal delivery of biopharmaceuticals.

Bruno Sarmento is an affiliated researcher at INEB – Instituto de Engenharia Biomédica, University of Porto, Portugal. He is also an assistant professor of pharmaceutical and biopharmaceutical technology at Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, Portugal. He earned a Ph.D. in Pharmaceutical Technology at the University of Porto. He has extensive work in the development of nanocarriers for the oral delivery of biopharmaceuticals—namely insulin—and the establishment of novel in vitro intestinal permeability models. His current research focuses on nanomedicines and their applications in the pharmaceutical and biomedical fields.

Blurb

This book provides a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals as well as the technological strategies that have been followed so far regarding the optimization of mucosal potentialities. The book also addresses the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. After a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects towards beneficial or deleterious interactions with biopharmaceuticals and delivery systems. The second part is dedicated to the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications, either factual or potential, of particular pharmaceutical delivery systems and products enclosing biopharmaceuticals for mucosal delivery. Special focus is set on the most successful case studies of recent years by field experts or those engaged in developing such solutions in a concise and practical way. The last section briefly centers on pertinent aspects about the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals.

 

José das Neves is a researcher at Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, and in the Faculty of Pharmacy, University of Porto, Portugal, where he earned a Ph.D. in Pharmaceutical Sciences. His previous work has spanned multiple aspects of the development of vaginal drug delivery systems, and his current research interests include the development of nanotechnology-based solutions for the development of anti-HIV microbicides and mucosal delivery of biopharmaceuticals.

 

Bruno Sarmento is an affiliated researcher at INEB – Instituto de Engenharia Biomédica, University of Porto, Portugal. He is also an assistant professor of pharmaceutical and biopharmaceutical technology at Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, Portugal. He earned a Ph.D. in Pharmaceutical Technology at the University of Porto. He has extensive work in the development of nanocarriers for the oral delivery of biopharmaceuticals—namely insulin—and the establishment of novel in vitro intestinal permeability models. His current research focuses on nanomedicines and their applications in the pharmaceutical and biomedical fields.