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E-grāmata: Chitosan-Based Systems for Biopharmaceuticals: Delivery, Targeting and Polymer Therapeutics

Edited by (Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Porto, Portugal), Edited by (Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Porto, Portugal)
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  • Izdošanas datums: 16-Feb-2012
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9781119962960
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Chitosan-Based Systems for Biopharmaceuticals: Delivery, Targeting and Polymer TherapeuticsPalielināt
  • Formāts: PDF+DRM
  • Izdošanas datums: 16-Feb-2012
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9781119962960
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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.

List of Contributors
xvii
Foreword xxiii
Maria Jose Alonso
Preface xxv
Acknowledgments xxvii
Part One General Aspects of Chitosan
1(124)
1 Chemical and Technological Advances in Chitins and Chitosans Useful for the Formulation of Biopharmaceuticals
3(20)
Riccardo A. A. Muzzarelli
1.1 Introduction
3(1)
1.2 Safety of Chitins and Chitosans
4(1)
1.3 Ionic Liquids: New Solvents and Reaction Media
5(3)
1.4 Chitin and Chitosan Nanofibrils
8(2)
1.4.1 Mechanically Isolated Nanofibrils in the Presence of Acetic Acid
8(1)
1.4.2 Nanochitosan Obtained from Partially Deacetylated Chitin or Deacetylated Nanochitin
9(1)
1.5 Electrospun Nanofibers
10(2)
1.6 Polyelectrolyte Complexes and Mucoadhesion
12(4)
1.6.1 Chitosan Polyelectrolyte Complexes Soluble in Alkaline Medium
14(1)
1.6.2 Polyelectrolyte Complexes of Regioselectively Oxidized Chitin
15(1)
1.6.3 Polyelectrolyte Complexes of Chitosan with Bacterial Cell Wall Components
15(1)
1.7 Conclusions and Future Perspectives
16(7)
Acknowledgments
16(1)
References
16(7)
2 Physical Properties of Chitosan and Derivatives in Sol and Gel States
23(22)
Marguerite Rinaudo
2.1 Introduction
23(1)
2.2 Chitin
24(4)
2.2.1 Solid State of Chitin
24(1)
2.2.2 Solubility of Chitin
24(2)
2.2.3 Characterization of Chitin
26(2)
2.2.4 Processing of Chitin Solution and Physical Properties of Materials
28(1)
2.3 Chitosan
28(8)
2.3.1 Solubility of Chitosan
28(1)
2.3.2 Characterization of Chitosan
29(2)
2.3.3 Processing of Chitosan-Based Materials
31(1)
2.3.4 Complex Materials Based on Interacting Chitosan and Chitosan Derivatives
31(5)
2.4 Conclusions and Future Perspectives
36(9)
References
36(9)
3 Absorption Promotion Properties of Chitosan and Derivatives
45(12)
Akira Yamamoto
3.1 Introduction
45(2)
3.2 Effect of Chitosan on the Intestinal Absorption of Poorly Absorbable Drugs
47(1)
3.3 Effect of Chitosan Derivatives on the Intestinal Absorption of Poorly Absorbable Drugs
47(1)
3.4 Effect of Chitosan Oligomers on the Intestinal Absorption of Poorly Absorbable Drugs
48(3)
3.5 Colon-Specific Delivery of Insulin Using Chitosan Capsules
51(3)
3.6 Conclusions and Future Perspectives
54(3)
References
54(3)
4 Biocompatibility and Biodegradation of Chitosan and Derivatives
57(18)
Ahmad Sukari Halim
Lim Chin Keong
Ismail Zainol
Ahmad Hazri Abdul Rashid
4.1 Introduction
57(1)
4.2 Biocompatibility Evaluation of Chitosan and Derivatives
58(7)
4.2.1 In Vitro Biocompatibility
60(3)
4.2.2 In Vivo Biocompatibility
63(1)
4.2.3 Effect of Sterilization on Biocompatibility
64(1)
4.3 Biodegradation of Chitosan and Derivatives
65(4)
4.3.1 Factors Influencing the Biodegradation of Chitosan and Derivatives
67(1)
4.3.2 In Vitro Biodegradation of Chitosan and Derivatives
68(1)
4.3.3 In Vivo Biodegradation of Chitosan and Derivatives
69(1)
4.4 Conclusions and Future Perspectives
69(6)
References
70(5)
5 Biological and Pharmacological Activity of Chitosan and Derivatives
75(18)
Teresa Cunha
Branca Teixeira
Barbara Santos
Marlene Almeida
Gustavo Dias
Jose das Neves
5.1 Introduction
75(1)
5.2 Biological Activity
76(6)
5.2.1 Antimicrobial Activity
76(1)
5.2.2 Immune Effects and Anti-Inflammatory Activity
77(1)
5.2.3 Antioxidant Activity
78(1)
5.2.4 Anticancer Activity
79(1)
5.2.5 Blood Coagulation Effects
79(1)
5.2.6 Antidiabetic Activity
80(1)
5.2.7 Neuroprotective Activity
80(1)
5.2.8 Other Biological Activities
81(1)
5.3 Chitosan's Usefulness in Therapy and Alternative Medicine
82(2)
5.3.1 Wound Healing
82(1)
5.3.2 Obesity
82(1)
5.3.3 Dyslipidemia
83(1)
5.3.4 Dental Plaque
83(1)
5.3.5 Renal Failure
83(1)
5.3.6 Other Uses
84(1)
5.4 Conclusions and Future Perspectives
84(9)
Acknowledgments
85(1)
References
85(7)
Further Reading
92(1)
6 Biological, Chemical, and Physical Compatibility of Chitosan and Biopharmaceuticals
93(14)
Masayuki Ishihara
Masanori Fujita
Satoko Kishimoto
Hidemi Hattori
Yasuhiro Kanatani
6.1 Introduction
93(1)
6.2 Structural Features of Chitosan and Its Derivatives
94(1)
6.3 Biocompatibility for Chitosan and Its Derivatives
95(3)
6.3.1 Inflammatory Reaction
95(1)
6.3.2 Foreign Body Reaction
96(1)
6.3.3 Biocompatibility Testing
97(1)
6.4 Biocompatibility of Photo-Cross-Linkable Chitosan Hydrogel
98(2)
6.4.1 Photo-Cross-Linkable Chitosan Hydrogel
98(1)
6.4.2 Photo-Cross-Linkable Chitosan Hydrogel as a Biological Adhesive
99(1)
6.4.3 Photo-Cross-Linkable Chitosan Hydrogel as a Wound Dressing
99(1)
6.4.4 Safety of Photo-Cross-Linkable Chitosan Hydrogel
99(1)
6.5 Physical and Chemical Compatibility of Chitosan and Its Derivatives
100(2)
6.5.1 Chitosan-Based Peptide and Protein Delivery Systems
101(1)
6.5.2 Chitosan-Based Gene Delivery Systems
101(1)
6.5.3 Physicochemical Characterization of Protein-, Peptide-, or Gene-Loaded Chitosan-Based PECs
101(1)
6.6 Conclusions and Future Perspectives
102(5)
References
103(4)
7 Approaches for Functional Modification or Cross-Linking of Chitosan
107(18)
A. Anitha
N. Sanoj Rejinold
Joel D. Bumgardner
Shanti V. Nair
Rangasamy Jayakumar
7.1 Introduction
107(1)
7.2 General Awareness of Chitosan Cross-Linking Methods
108(4)
7.2.1 Chemical Cross-Linking
108(3)
7.2.2 Radiation Cross-Linking
111(1)
7.2.3 Physical Cross-Linking
111(1)
7.3 Modified Chitosan: Synthesis and Characterization
112(6)
7.3.1 Synthesis of Water-soluble Chitosan Derivatives
112(1)
7.3.2 Thiolation
113(1)
7.3.3 Succinylation
113(2)
7.3.4 Chitosan-Grafted Polymers
115(3)
7.4 Applications of Modified Chitosan and Its Derivatives in Drug Delivery
118(1)
7.5 Conclusions and Future Perspectives
118(7)
Acknowledgments
118(1)
References
119(6)
Part Two Biopharmaceuticals Formulation and Delivery Aspects Using Chitosan and Derivatives
125(150)
8 Use of Chitosan and Derivatives in Conventional Biopharmaceutical Dosage Forms Formulation
127(10)
Teofilo Vasconcelos
Pedro Barrocas
Rui Cerdeira
8.1 Introduction
127(1)
8.2 Advantageous Properties of Chitosan and Its Derivatives
128(1)
8.3 Oral Administration
129(2)
8.4 Buccal Administration
131(1)
8.5 Nasal Administration
132(1)
8.6 Pulmonary Administration
132(1)
8.7 Transdermal Administration
133(1)
8.8 Conclusions and Future Perspectives
133(4)
References
134(3)
9 Manufacture Techniques of Chitosan-Based Microparticles and Nanoparticles for Biopharmaceuticals
137(22)
Franca Ferrari
M. Cristina Bonferoni
Silvia Rossi
Giuseppina Sandri
Carla M. Caramella
9.1 Introduction
137(1)
9.2 Water-in-Oil Emulsion and Chemical Cross-linking
138(3)
9.3 Drying Techniques
141(3)
9.3.1 Spray Drying
141(1)
9.3.2 Supercritical Fluid Drying
142(1)
9.3.3 Electrospraying
143(1)
9.4 Ionic Cross-linking Methods
144(7)
9.4.1 Low-MW Molecules
145(3)
9.4.2 Macromolecules
148(3)
9.5 Coacervation and Precipitation Method
151(1)
9.6 Direct Interaction between Chitosan and Biopharmaceuticals
152(1)
9.6.1 DNA-Chitosan Interaction
152(1)
9.6.2 siRNA-Chitosan Interaction
153(1)
9.7 Conclusions and Future Perspectives
153(6)
References
154(5)
10 Chitosan and Derivatives for Biopharmaceutical Use: Mucoadhesive Properties
159(22)
Katharina Leithner
Andreas Bernkop-Schnurch
10.1 Introduction
159(1)
10.2 Mucoadhesion
160(1)
10.2.1 The Mucus
160(1)
10.2.2 The Interaction of Mucoadhesives and Mucosa
160(1)
10.2.3 Mucoadhesion
160(1)
10.2.4 Chitosan as a Mucoadhesive Polymer
161(1)
10.3 Chitosan and Its Derivatives
161(10)
10.3.1 Overview
161(1)
10.3.2 Thiolated Chitosan
161(3)
10.3.3 Chitosan-EDTA and Chitosan-DTPA
164(3)
10.3.4 Trimethyl Chitosan
167(1)
10.3.5 Mono-N-Carboxymethyl Chitosan
168(1)
10.3.6 N-Sulfonato-N, O-Carboxymethylchitosan
168(1)
10.3.7 Hydrophobically Modified Chitosans
169(1)
10.3.8 PEGylated Chitosan
170(1)
10.3.9 Chitosan-Succinate and Chitosan-Phthalate
170(1)
10.4 Biopharmaceutical Use of Chitosan and Its Derivatives
171(4)
10.4.1 Overview
171(1)
10.4.2 Oral Drug Delivery
171(3)
10.4.3 Nasal Drug Delivery
174(1)
10.4.4 Buccal Drug Delivery
175(1)
10.5 Conclusions and Future Perspectives
175(6)
References
176(5)
11 Chitosan-Based Systems for Mucosal Delivery of Biopharmaceuticals
181(30)
Sonia Al-Qadi
Ana Grenha
Carmen Remunan-Lopez
11.1 Introduction
181(1)
11.2 Important Challenges for the Delivery of Biopharmaceuticals by Mucosal Routes
182(2)
11.3 Interest in Chitosan for Mucosal Delivery of Biopharmaceuticals
184(4)
11.3.1 Chitosan Physicochemical Properties
184(1)
11.3.2 Biological Properties of Chitosan
185(1)
11.3.3 Mucoadhesive and Permeation-Enhancing Properties
186(1)
11.3.4 Chitosan Derivatives
187(1)
11.4 Chitosan-Based Delivery Nanosystems for Mucosal Delivery of Biopharmaceuticals
188(12)
11.4.1 Oral Delivery of Biopharmaceuticals
189(3)
11.4.2 Nasal Delivery of Biopharmaceuticals
192(3)
11.4.3 Pulmonary Delivery of Biopharmaceuticals
195(5)
11.5 Conclusions and Future Perspectives
200(11)
Acknowledgments
200(1)
References
201(10)
12 Chitosan-Based Delivery Systems for Mucosal Vaccination
211(14)
Gerrit Borchard
Farnaz Esmaeili
Simon Heuking
12.1 Introduction
211(1)
12.2 Adjuvant Properties of Chitosan
212(1)
12.3 Chitosan in the Delivery of Protein and Subunit Vaccines
213(2)
12.4 Chitosan-Based Formulations of DNA Vaccines
215(1)
12.5 Vaccine Formulations Using Chitosan in Combination with Other Polymers
216(1)
12.6 Chitosan Derivatives in Vaccine Carrier Design
217(3)
12.6.1 N, N, N-Trimethyl Chitosan
217(1)
12.6.2 Nasal Delivery of TMC-Based Vaccine Formulations
218(1)
12.6.3 Pulmonary Delivery of TMC-Based Vaccine Formulations
219(1)
12.6.4 Oral Delivery of TMC-Based Vaccine Formulations
219(1)
12.6.5 Other Chitosan Derivatives
219(1)
12.7 Conclusions and Future Perspectives
220(5)
References
220(5)
13 Chitosan-Based Nanoparticulates for Oral Delivery of Biopharmaceuticals
225(18)
Filipa Antunes
Fernanda Andrade
Bruno Sarmento
13.1 Introduction
225(1)
13.2 Challenges on the Oral Delivery of Therapeutic Proteins
226(1)
13.3 Challenges on the Oral Delivery of Genetic Material
227(2)
13.4 Role of Chitosan in the Protection of Biopharmaceuticals in the Gastrointestinal Tract
229(3)
13.5 Chitosan-Based Nanoparticles for Oral Delivery of Therapeutic Proteins
232(2)
13.6 Chitosan-Based Nanoparticles for Oral Delivery of Genetic Material
234(2)
13.7 Conclusions and Future Perspectives
236(7)
Acknowledgments
237(1)
References
237(6)
14 Chitosan-Based Systems for Ocular Delivery of Biopharmaceuticals
243(12)
Suresh P. Vyas
Rishi Paliwal
Shivani Rai Paliwal
14.1 Introduction
243(1)
14.2 Ocular Delivery of Biopharmaceuticals
244(1)
14.3 Chitosan: A Suitable Biomaterial for Ocular Therapeutics
244(1)
14.4 Chitosan-Based Systems for Ocular Delivery of Biomacromolecules
245(4)
14.4.1 Chitosan Solutions as Permeation Enhancers
245(1)
14.4.2 Chitosan-Based Nanoemulsions
246(1)
14.4.3 Chitosan Micro- and Nanoparticles
247(1)
14.4.4 Chitosan-Coated Delivery Systems
248(1)
14.4.5 Chitosan Complexed with Other Biomaterials
248(1)
14.5 Toxicological and Compatibility Aspects of Chitosan-Based Ocular Systems
249(1)
14.6 Conclusions and Future Perspectives
250(5)
References
250(5)
15 Chemical Modification of Chitosan for Delivery of DNA and siRNA
255(20)
You-Kyoung Kim
Hu-Lin Jiang
Ding-Ding Guo
Yun-Jaie Choi
Myung-Haing Cho
Toshihiro Akaike
Chong-Su Cho
15.1 Introduction
255(1)
15.2 Hydrophilic Modification
256(1)
15.3 Hydrophobic Modification
257(2)
15.4 Specific Ligand Modification
259(5)
15.4.1 Galactose Ligand
259(2)
15.4.2 Mannose Ligand
261(2)
15.4.3 Folate Ligand
263(1)
15.5 pH-Sensitive Modification
264(5)
15.5.1 Imidazole
264(3)
15.5.2 PEI
267(2)
15.5.3 Spermine
269(1)
15.5.4 PAMAM Dendron
269(1)
15.6 Conclusions and Future Perspectives
269(6)
Acknowledgment
269(1)
References
269(6)
Part Three Advanced Application of Chitosan and Derivatives for Biopharmaceuticals
275(176)
16 Target-Specific Chitosan-Based Nanoparticle Systems for Nucleic Acid Delivery
277(24)
Shardool Jain
Mansoor Amiji
16.1 Introduction
277(6)
16.1.1 Nanotechnology in Vaccine and Drug Delivery
277(1)
16.1.2 Chitosan: A Versatile Biopolymer
278(1)
16.1.3 Chitosan for Delivery of Nucleic Acid Vaccines and Therapies
279(1)
16.1.4 Passive versus Active Systemic Targeted Delivery
280(3)
16.2 Chitosan-Based Nanoparticle Delivery Systems
283(3)
16.2.1 Chitosan-Based Nanodelivery Systems for DNA Vaccines
283(2)
16.2.2 Chitosan-Based Nanodelivery Systems for Nucleic Acid Therapy
285(1)
16.3 Illustrative Examples of DNA Vaccine Delivery
286(2)
16.3.1 Mucosal Vaccination
286(1)
16.3.2 Systemic Vaccination
287(1)
16.4 Illustrative Examples of Nucleic Acid Delivery Systems for Cancer Therapy
288(3)
16.5 Illustrative Examples of Nucleic Acid Delivery Systems for Anti-Inflammatory Therapy
291(3)
16.6 Conclusions and Future Perspectives
294(7)
References
295(6)
17 Functional PEGylated Chitosan Systems for Biopharmaceuticals
301(18)
Hee-Jeong Cho
Goen Kim
Hyeok-Seung Kwon
Yu-Kyoung Oh
17.1 Introduction
301(3)
17.1.1 Physicochemical Properties of PEGylated Chitosan
302(1)
17.1.2 Biological Properties of PEGylated Chitosan
303(1)
17.2 PEGylated Chitosan for the Delivery of Proteins and Peptides
304(4)
17.2.1 Protein Delivery
304(3)
17.2.2 Peptide Delivery
307(1)
17.3 PEGylated Chitosan for Delivery of Nucleic Acids
308(3)
17.3.1 Plasmid DNA Delivery
308(2)
17.3.2 Oligonucleotide Delivery
310(1)
17.4 PEGylated Chitosan for Delivery of Other Macromolecular Biopharmaceuticals
311(2)
17.5 PEGylated Chitosan Used for Cellular Scaffolds
313(1)
17.6 Conclusions and Future Perspectives
313(6)
References
314(5)
18 Stimuli-Sensitive Chitosan-Based Systems for Biopharmaceuticals
319(14)
Cuiping Zhai
Jinfang Yuan
Qingyu Gao
18.1 Introduction
319(1)
18.2 pH-Sensitive Chitosan-Based Systems
319(2)
18.3 Thermosensitive Chitosan-Based Systems
321(2)
18.4 pH-Sensitive and Thermosensitive Chitosan-Based Systems
323(2)
18.5 pH- and Ionic-Sensitive Chitosan-Based Systems
325(1)
18.6 Photo-Sensitive Chitosan-Based Systems
325(1)
18.7 Electrical-Sensitive Chitosan-Based Systems
326(1)
18.8 Magnetic-Sensitive Chitosan-Based Systems
326(1)
18.9 Chemical Substance-Sensitive Chitosan-Based Systems
327(1)
18.10 Conclusions and Future Perspectives
327(6)
References
328(5)
19 Chitosan Copolymers for Biopharmaceuticals
333(48)
Ramon Novoa-Carballal
Ricardo Riguera
Eduardo Fernandez-Megia
19.1 Introduction
333(4)
19.1.1 General Copolymerization Methods
334(2)
19.1.2 Chitosan Copolymers for Biopharmaceuticals
336(1)
19.1.3 The Integrity of the Chitosan Chain in Chitosan Copolymers
336(1)
19.2 Chitosan-g-Poly(Ethylene Glycol)
337(10)
19.2.1 Synthetic Procedures towards the Preparation of Chitosan-g-Poly(Ethylene Glycol)
337(10)
19.2.2 Applications of Chitosan-g-Poly(Ethylene Glycol) with Biopharmaceuticals
347(1)
19.3 Chitosan-g-Polyethylenimine
347(10)
19.3.1 Synthetic Strategies toward the Preparation of Chitosan-g-Polyethylenimine
350(3)
19.3.2 Applications to Gene Therapy
353(4)
19.4 Other Copolymers of Chitosan
357(6)
19.4.1 Chitosan-g-Polypeptide
357(1)
19.4.2 Grafting of Chitosan to Thermoresponsive Polymers
357(5)
19.4.3 Chitosan-g-Methacrylates
362(1)
19.5 Copolymers of Chitosan with Promising Applications
363(5)
19.5.1 Chitosan-g-Polyesters
363(3)
19.5.2 Chitosan-g-Polysaccharides
366(1)
19.5.3 Block Copolymers of Chitosan
367(1)
19.5.4 Chitosan-g-Dendrimer
368(1)
19.6 Conclusions and Future Perspectives
368(13)
References
369(12)
20 Application of Chitosan for Anticancer Biopharmaceutical Delivery
381(12)
Clandia Philippi
Brigitta Loretz
Ulrich F. Schaefer
Claus-Michael Lehr
20.1 Introduction
381(1)
20.2 Chitosan and Cancer: Intrinsic Antitumor Activity of the Polymer Itself
382(1)
20.2.1 Effects of Chitosan, Low-Molecular Weight Chitosan, and Chitooligosaccharides
382(1)
20.2.2 Effects of Chitosan Nanoparticles
383(1)
20.3 Chitosan Formulations Developed for Classic Anticancer Drugs
383(1)
20.3.1 Chemically Modified Chitosans or Chitosan-Drug Conjugates
383(1)
20.3.2 Nanoparticulate Carrier Systems
384(1)
20.3.3 Chitosans as Absorption Enhancers
384(1)
20.4 Biopharmaceuticals Delivered by Chitosan Preparations
384(4)
20.4.1 Nucleic Acid-Based Therapeutics
385(2)
20.4.2 Peptide-Based Actives for Cancer Treatment
387(1)
20.5 Active Targeting Strategies and Multifunctional Chitosan Formulations
388(1)
20.5.1 Active Targeting Strategies
388(1)
20.5.2 Multifunctional Chitosan Nanoparticles
389(1)
20.6 Conclusions and Future Perspectives
389(4)
References
390(3)
21 Chitosan-Based Biopharmaceutical Scaffolds in Tissue Engineering and Regenerative Medicine
393(36)
Tao Jiang
Meng Deng
Wafa I. Abdel-Fattah
Cato T. Laurencin
21.1 Introduction
393(2)
21.2 Fabrication of Chitosan-Based Biopharmaceuticals Scaffolds
395(8)
21.2.1 Techniques for Fabricating Chitosan-Based Scaffolds
395(7)
21.2.2 Functionalization of Chitosan-Based Scaffolds via Biopharmaceuticals
402(1)
21.3 Applications of Chitosan-Based Biopharmaceutical Scaffolds in Tissue Engineering and Regenerative Medicine
403(13)
21.3.1 Regeneration of Soft Tissue
404(6)
21.3.2 Regeneration of Hard Tissue
410(6)
21.4 Future Trends: Regenerative Engineering
416(1)
21.5 Conclusions and Future Perspectives
417(12)
Acknowledgments
417(1)
References
418(11)
22 Wound-Healing Properties of Chitosan and Its Use in Wound Dressing Biopharmaceuticals
429(22)
Tyler G. St. Denis
Tianhong Dai
Ying-Ying Huang
Michael R. Hamblin
22.1 Introduction
429(1)
22.2 Brief Review of Wound Repair
430(3)
22.2.1 Inflammatory Phase
430(1)
22.2.2 Proliferative Phase
431(1)
22.2.3 Remodeling Phase
432(1)
22.3 Wound-Healing Effects of Chitosan
433(7)
22.3.1 In Vitro Studies
433(2)
22.3.2 In Vivo Studies
435(3)
22.3.3 Clinical Studies
438(2)
22.4 Chitosan for Wound Therapeutics Delivery
440(4)
22.4.1 Antimicrobials
440(2)
22.4.2 Combination with Photodynamic Therapy
442(1)
22.4.3 Growth Factors
443(1)
22.4.4 Delivery of Other Drugs
444(1)
22.5 Conclusions and Future Perspectives
444(7)
Acknowledgments
447(1)
References
447(4)
Part Four Regulatory Status, Toxicological Issues, and Clinical Perspectives
451(92)
23 Toxicological Properties of Chitosan and Derivatives for Biopharmaceutical Applications
453(10)
Thomas J. Kean
Maya Thanou
23.1 Introduction
453(1)
23.2 In Vitro Toxicity of Chitosan and Derivatives
454(3)
23.2.1 In Vitro Toxicity of Chitosan
454(1)
23.2.2 In Vitro Toxicity of Chitosan Derivatives
455(1)
23.2.3 In Vitro Toxicity of Chitosan Formulations
455(2)
23.2.4 Antibacterial, Antifungal, and Antiparasitic Activities of Chitosan and Chitosan Derivatives
457(1)
23.3 In Vivo Toxicity of Chitosan and Derivatives
457(2)
23.3.1 In Vivo Toxicity of Chitosan
457(1)
23.3.2 In Vivo Toxicity of Chitosan Derivatives
458(1)
23.3.3 In Vivo Toxicity of Chitosan Formulations
458(1)
23.4 Conclusions and Future Perspectives
459(4)
References
459(4)
24 Regulatory Status of Chitosan and Derivatives
463(20)
Michael Dornish
David S. Kaplan
Sambasiva R. Arepalli
24.1 Introduction
463(1)
24.2 Source
464(1)
24.3 Characterization
464(1)
24.4 Purity
465(1)
24.4.1 Impurities
465(1)
24.4.2 Heavy Metals
465(1)
24.4.3 Protein
465(1)
24.4.4 Microbiological Bioburden
466(1)
24.4.5 Bacterial Endotoxin
466(1)
24.5 Applications of Advanced Uses of Chitosan
466(2)
24.5.1 Tissue Engineering
466(1)
24.5.2 Gene Delivery with Chitosan
467(1)
24.5.3 Nasal Drug and Vaccine Delivery
467(1)
24.6 Regulatory Considerations for Chitosan and Chitosan Derivatives in the European Union, and Medical Devices or Combination Products with Medical Device (CDRH) Lead
468(1)
24.6.1 The US Food and Drug Administration
468(1)
24.7 Regulatory Pathways
469(1)
24.8 Chitosan Medical Products: US Regulatory Review Processes for Medical Devices or Combination Products with CDRH Lead
469(1)
24.9 Chitosan Wound Dressings
470(4)
24.9.1 Hemostasis and Antimicrobial Activities
470(4)
24.10 The European Regulatory System: The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines (EDQM)
474(1)
24.10.1 Pharmaceuticals - Europe
474(1)
24.10.2 Medical Devices - Europe
475(1)
24.11 Further Regulatory Considerations
475(2)
24.11.1 Generally Recognized as Safe (GRAS)
476(1)
24.11.2 Pharmacopoeia Monographs
476(1)
24.11.3 Standards Development Organizations
476(1)
24.12 Conclusions and Future Perspectives
477(1)
Acknowledgments
478(1)
24.13 Disclaimer
478(5)
References
478(5)
25 Patentability and Intellectual Property Issues Related to Chitosan-Based Biopharmaceutical Products
483(20)
Mafalda Videira
Rogerio Gaspar
25.1 Introduction
483(1)
25.2 Setting the Scene: The Role of Chitosan as a Pharmaceutical Excipient
484(11)
25.2.1 Current Achievements in Chitosan Use
484(2)
25.2.2 Chitosan-Based Ocular Therapy
486(1)
25.2.3 Tissue Engineering and Wound Management
487(1)
25.2.4 Drug Delivery Systems: Emerging Targeting Solutions
488(6)
25.2.5 Recent Trends in Using Chitosan
494(1)
25.3 Addressing the Drivers for Scientific Progress on Chitosan: Innovation and Inventability
495(1)
25.3.1 Is There a Next Generation of Chitosan?
495(1)
25.4 Conclusions and Future Perspectives
496(7)
References
497(6)
26 Quality Control and Good Manufacturing Practice (GMP) for Chitosan-Based Biopharmaceutical Products
503(22)
Torsten Richter
Maika Gulich
Katja Richter
List of Abbreviations
503(1)
26.1 Introduction
504(1)
26.2 Regulatory Requirements for Production
505(3)
26.2.1 Medical Devices
505(1)
26.2.2 Excipients
506(1)
26.2.3 APIs/Pharmaceuticals
507(1)
26.3 Manufacturing GMP: Fundamental Considerations
508(3)
26.4 Requirements for Rooms, Personnel, and Equipment
511(1)
26.5 Qualification and Validation
511(2)
26.5.1 Qualification
511(2)
26.5.2 Process Validation
513(1)
26.6 Quality Control
513(6)
26.6.1 Specific Features of Chitosan Quality Control
516(3)
26.7 Monitoring and Maintenance of a GMP System
519(3)
26.7.1 Vendor and Customer Audits
519(2)
26.7.2 Public Authority Inspections
521(1)
26.8 Conclusions and Future Perspectives
522(3)
References
522(3)
27 Preclinical and Clinical Use of Chitosan and Derivatives for Biopharmaceuticals: From Preclinical Research to the Bedside
525(18)
David A. Zaharoff
Michael Heffernan
Jonathan Fallon
John W. Greiner
27.1 Introduction
525(1)
27.2 Chitosan as a Parenteral (Subcutaneous) Vaccine Platform
526(4)
27.2.1 Enhancement of Humoral and Cell-Mediated Immune Responses
526(1)
27.2.2 Enhancement of the Immunoadjuvant Properties of GM-CSF
527(3)
27.3 Chitosan as an Immunotherapeutic Platform
530(7)
27.3.1 Intratumoral Immunotherapy with Chitosan-IL-12
530(5)
27.3.2 Intravesical Immunotherapy of Superficial Bladder Carcinoma with Chitosan-IL-12
535(2)
27.4 Conclusions and Future Perspectives
537(6)
References
539(4)
Index 543
Bruno Sarmento, Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Porto, Porto, Portugal & CICS, Department of Pharmaceutical Sciences, Instituto Superior de Ciźncias da SaśdeNorte, Gandra, Portugal José das Neves, Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Porto, Porto, Portugal
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