Chitosan-Based Systems for Biopharmaceuticals
Delivery, Targeting and Polymer Therapeutics
1. Edition March 2012
584 Pages, Hardcover
Wiley & Sons Ltd
Chitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible, and acts as a bioadhesive with otherwise unstable biomolecules - making it a valuable component in the formulation of biopharmaceutical drugs.
Chitosan-Based Systems for Biopharmaceuticals provides an extensive overview of the application of chitosan and its derivatives in the development and optimisation of biopharmaceuticals. The book is divided in four different parts. Part I discusses general aspects of chitosan and its derivatives, with particular emphasis on issues related to the development of biopharmaceutical chitosan-based systems. Part II deals with the use of chitosan and derivatives in the formulation and delivery of biopharmaceuticals, and focuses on the synergistic effects between chitosan and this particular subset of pharmaceuticals. Part III discusses specific applications of chitosan and its derivatives for biopharmaceutical use. Finally, Part IV presents diverse viewpoints on different issues such as regulatory, manufacturing and toxicological requirements of chitosan and its derivatives related to the development of biopharmaceutical products, as well as their patent status, and clinical application and potential.
Topics covered include:
* chemical and technological advances in chitins and chitosans useful for the formulation of biopharmaceuticals
* physical properties of chitosan and derivatives in sol and gel states
* absorption promotion properties of chitosan and derivatives
* biocompatibility and biodegradation of chitosan and derivatives
* biological and pharmacological activity of chitosan and derivatives
* biological, chemical and physical compatibility of chitosan and biopharmaceuticals
* approaches for functional modification or crosslinking of chitosan
* use of chitosan and derivatives in conventional biopharmaceutical dosage forms
* manufacture techniques of chitosan-based microparticles and nanoparticles for biopharmaceuticals
* chitosan and derivatives for biopharmaceutical use: mucoadhesive properties
* chitosan-based systems for mucosal delivery of biopharmaceuticals
* chitosan-based delivery systems for mucosal vaccination
* chitosan-based nanoparticulates for oral delivery of biopharmaceuticals
* chitosan-based systems for ocular delivery of biopharmaceuticals
* chemical modification of chitosan for delivery of DNA and siRNA
* target-specific chitosan-based nanoparticle systems for nucleic acid delivery
* functional PEGylated chitosan systems for biopharmaceuticals
* stimuli-sensitive chitosan-based systems for biopharmaceuticals
* chitosan copolymers for biopharmaceuticals
* application of chitosan for anti-cancer biopharmaceutical delivery
* chitosan-based biopharmaceuticals scaffolds in tissue engineering and regenerative medicine
* wound healing properties of chitosan and its use in wound dressing biopharmaceuticals
* toxicological properties of chitosan and derivatives for biopharmaceutical applications
* regulatory status of chitosan and derivatives
* patentability and intellectual property issues
* quality control and good manufacturing practice
* preclinical and clinical use of chitosan and derivatives for biopharmaceuticals
Chitosan-Based Systems for Biopharmaceuticals is an important compendium of fundamental concepts, practical tools and applications of chitosan-based biopharmaceuticals for researchers in academia and industry working in drug formulation and delivery, biopharmaceuticals, medicinal chemistry, pharmacy, bioengineering and new materials development.
Foreword xxiii
Mar1a Jose Alonso
Preface xxv
Acknowledgments xxvii
Part One General Aspects of Chitosan 1
1 Chemical and Technological Advances in Chitins and Chitosans Useful for the Formulation of Biopharmaceuticals 3
Riccardo A. A. Muzzarelli
2 Physical Properties of Chitosan and Derivatives in Sol and Gel States 23
Marguerite Rinaudo
3 Absorption Promotion Properties of Chitosan and Derivatives 45
Akira Yamamoto
4 Biocompatibility and Biodegradation of Chitosan and Derivatives 57
Ahmad Sukari Halim, Lim Chin Keong, Ismail Zainol, and Ahmad Hazri Abdul Rashid
5 Biological and Pharmacological Activity of Chitosan and Derivatives 75
Teresa Cunha, Branca Teixeira, Barbara Santos, Marlene Almeida, Gustavo Dias, and Jose das Neves
6 Biological, Chemical, and Physical Compatibility of Chitosan and Biopharmaceuticals 93
Masayuki Ishihara, Masanori Fujita, Satoko Kishimoto, Hidemi Hattori, and Yasuhiro Kanatani
7 Approaches for Functional Modification or Cross-Linking of Chitosan 107
A. Anitha, N. Sanoj Rejinold, Joel D. Bumgardner, Shanti V. Nair, and Rangasamy Jayakumar
Part Two Biopharmaceuticals Formulation and Delivery Aspects Using Chitosan and Derivatives 125
8 Use of Chitosan and Derivatives in Conventional Biopharmaceutical Dosage Forms Formulation 127
Teofilo Vasconcelos, Pedro Barrocas, and Rui Cerdeira
9 Manufacture Techniques of Chitosan-Based Microparticles and Nanoparticles for Biopharmaceuticals 137
Franca Ferrari, M. Cristina Bonferoni, Silvia Rossi, Giuseppina Sandri, and Carla M. Caramella
10 Chitosan and Derivatives for Biopharmaceutical Use: Mucoadhesive Properties 159
Katharina Leithner and Andreas Bernkop-Schnurch
11 Chitosan-Based Systems for Mucosal Delivery of Biopharmaceuticals 181
Sonia Al-Qadi, Ana Grenha, and Carmen Remunan-Lopez
12 Chitosan-Based Delivery Systems for Mucosal Vaccination 211
Gerrit Borchard, Farnaz Esmaeili, and Simon Heuking
13 Chitosan-Based Nanoparticulates for Oral Delivery of Biopharmaceuticals 225
Filipa Antunes, Fernanda Andrade, and Bruno Sarmento
14 Chitosan-Based Systems for Ocular Delivery of Biopharmaceuticals 243
Suresh P. Vyas, Rishi Paliwal, and Shivani Rai Paliwal
15 Chemical Modification of Chitosan for Delivery of DNA and siRNA 255
You-Kyoung Kim, Hu-Lin Jiang, Ding-Ding Guo, Yun-Jaie Choi, Myung-Haing Cho, Toshihiro Akaike, and Chong-Su Cho
Part Three Advanced Application of Chitosan and Derivatives for Biopharmaceuticals 275
16 Target-Specific Chitosan-Based Nanoparticle Systems for Nucleic Acid Delivery 277
Shardool Jain and Mansoor Amiji
17 Functional PEGylated Chitosan Systems for Biopharmaceuticals 301
Hee-Jeong Cho, Goen Kim, Hyeok-Seung Kwon, and Yu-Kyoung Oh
18 Stimuli-Sensitive Chitosan-Based Systems for Biopharmaceuticals 319
Cuiping Zhai, Jinfang Yuan, and Qingyu Gao
19 Chitosan Copolymers for Biopharmaceuticals 333
Ramon Novoa-Carballal, Ricardo Riguera, and Eduardo Fernandez-Megia
20 Application of Chitosan for Anticancer Biopharmaceutical Delivery 381
Claudia Philippi, Brigitta Loretz, Ulrich F. Schaefer, and Claus-Michael Lehr
21 Chitosan-Based Biopharmaceutical Scaffolds in Tissue Engineering and Regenerative Medicine 393
Tao Jiang, Meng Deng, Wafa I. Abdel- Fattah, and Cato T. Laurencin
22 Wound-Healing Properties of Chitosan and Its Use in Wound Dressing Biopharmaceuticals 429
Tyler G. St. Denis, Tianhong Dai, Ying-Ying Huang, and Michael R. Hamblin
Part Four Regulatory Status, Toxicological Issues, and Clinical Perspectives 451
23 Toxicological Properties of Chitosan and Derivatives for Biopharmaceutical Applications 453
Thomas J. Kean and Maya Thanou
24 Regulatory Status of Chitosan and Derivatives 463
Michael Dornish, David S. Kaplan, and Sambasiva R. Arepalli
25 Patentability and Intellectual Property Issues Related to Chitosan-Based Biopharmaceutical Products 483
Mafalda Videira and Rogerio Gaspar
26 Quality Control and Good Manufacturing Practice (GMP) for Chitosan-Based Biopharmaceutical Products 503
Torsten Richter, Maika Gulich, and Katja Richter
27 Preclinical and Clinical Use of Chitosan and Derivatives for Biopharmaceuticals: From Preclinical Research to the Bedside 525
David A. Zaharoff, Michael Heffernan, Jonathan Fallon, and John W. Greiner
References 539
Index 543
José das Neves, Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Porto, Porto, Portugal
