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Mucosal Delivery of Biopharmaceuticals: Biology, Challenges and Strategies
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 517Frédéric 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  002ced1a.jpg |
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