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[资源] Mucosal Delivery of Biopharmaceuticals: Biology, Challenges and Strategies

Mucosal Delivery of Biopharmaceuticals: Biology, Challenges and Strategies
José das Neves, Bruno Sarmento
Springer-
Published: 2014-02-17
ISBN: 1461495237

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.

2009.
Contents
Part I Biology of Mucosal Sites
1 Concepts in Mucosal Immunity and Mucosal Vaccines . . . . . . . . . . . . . 3
Simona Gallorini, Derek T. O’Hagan and Barbara C. Baudner
2 Mucoadhesion and Characterization of Mucoadhesive Properties . . . . 35
TaoYu, Gavin P. Andrews and David S. Jones
3 Mucus as a Barrier for Biopharmaceuticals and Drug Delivery Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Hongbo Zhang, Mohammed-Ali Shahbazi, Patrick V. Almeida and Hélder A. Santos
4 Epithelial Permeation and Absorption Mechanisms of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Hanne Mørck Nielsen
Part II Delivery Strategies for Specific Mucosal Sites
5 Oral Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Catarina Oliveira Silva, Bruno Sarmento and Catarina Pinto Reis
6 Buccal Delivery of Biopharmaceuticals: Vaccines and Allergens . . . . . 149
Sevda ¸ Senel, Merve Cansız and Michael J. Rathbone
7 Pulmonary Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . 169
Fernanda Andrade, Catarina Moura and Bruno Sarmento
8 Nasal Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
EijiYuba and Kenji Kono
9 Ocular Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Holly Lorentz and Heather Sheardown
10 Vaginal Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . 261
José das Neves
Part III Case Studies of Mucosal Delivery of Biopharmaceuticals
11 Nanoparticles-in-Microsphere Oral Delivery Systems (NiMOS)
for Nucleic Acid Therapy in the Gastrointestinal Tract . . . . . . . . . . . . . 283
Shardool Jain and Mansoor Amiji
12 Bacteria-Based Vectors for Oral Gene Therapy . . . . . . . . . . . . . . . . . . . . 313
Yong Bai, Rachael Burchfield, Sangwei Lu and Fenyong Liu
13 Self-Assembled Polysaccharide Nanogels for Nasal Delivery
of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Tomonori Nochi,YoshikazuYuki, Kazunari Akiyoshi and Hiroshi Kiyono
14 PheroidTM Vesicles and Microsponges for Nasal Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Lissinda H. du Plessis and Awie F. Kotzé
15 Delivery Strategies for Developing siRNA-Based Vaginal Microbicides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345
Joseph A. Katakowski and Deborah Palliser
16 Delivery Strategies for Developing Vaginal DNA Vaccine Combining
Cell-Penetrating Peptide and Jet Injection . . . . . . . . . . . . . . . . . . . . . . . . 367
Takanori Kanazawa and Hiroaki Okada
17 Vaccine Delivery Systems for Veterinary Immunization . . . . . . . . . . . . . 379
Juan M. Irache, Ana I. Camacho and Carlos Gamazo
18 Eligen® Technology for Oral Delivery of Proteins and Peptides . . . . . . 407
Sunita Prem Victor,Willi Paul and Chandra P. Sharma
19 The RapidMistTM System for Buccal Delivery of Insulin . . . . . . . . . . . . 423
Meena Bansal, Sanjay Bansal and Rachna Kumria
20 The Pharmaceutical Development of rhDNase (Dornase Alpha)
for the Treatment of Cystic Fibrosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437
Steven J. Shire and Thomas M. Scherer
21 Development of the Exubera® Insulin Pulmonary Delivery System . . . 461
Cynthia L. Stevenson and David B. Bennett
22 Technosphere®: An Inhalation System for Pulmonary Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483
António J. Almeida and Ana Grenha
23 ChiSys® as a Chitosan-Based Delivery Platform for Nasal Vaccination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 499
PeterWatts, Alan Smith and Michael Hinchcliffe
24 Development of a Cationic Nanoemulsion Platform (Novasorb®

for Ocular Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 517
Frédéric Lallemand, Philippe Daull and Jean-Sébastien Garrigue
Part IV Regulatory, Toxicological and Market Issues
25 Regulatory Aspects and Approval of Biopharmaceuticals for Mucosal Delivery: Quality, Toxicology, and Clinical Aspects . . . . . 539
Karen Brigitta Goetz,Yuansheng Sun, Katrin Féchir, Evelyne Kretzschmar and Isabel Buettel
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591