Foreword
Preface
Contributors
Chapter 1. An Overview of the Field of Peptide and Protein Delivery
1.1. Introduction
1.2. Current Formulation Development
1.3. Case Studies of Delivery Approaches: Cyclosporine A and Insulin
1.4. Controlled Delivery
1.5. Future Trends
1.6. Toxicity Profiles
1.7. Regulatory Matters
1.8. Commercialization Considerations
Chapter 2. Pulmonary Delivery of Peptides and Proteins
2.1. Introduction
2.2. Clinical Applications of Pulmonary Protein Delivery
2.3. Stability of Proteins and Peptides in Pulmonary Delivery Formulations
2.4. Types of Pulmonary Delivery Formulations
2.5. Packaging and Storage
2.6. Conclusions
Chapter 3. Nasal Delivery of Peptides and Proteins with Chitosan and Related Mucoadhesive Polymers
3.1. Introduction
3.2. Physiological Obstacles to Nasal Absorption
3.3. Mechanisms of Mucoadhesion
3.4. Mucoadhesive Polymers and Nasal Application
3.5. Thermal and pH Sensitive Polymers
3.6. Characterization and Evaluation of Mucoadhesive Polymers
3.7. Nasal (Ciliary) Toxicity
3.8. Nose to Brain Pathway: Future Considerations
Chapter 4. Transdermal Delivery of Peptides and Proteins
4.1. Introduction
4.2. Skin Structure
4.3. Rationale and Challenges for Transdermal Delivery of Peptides and Proteins
4.4. Techniques Enabling Transdermal Delivery of Peptides and Proteins
4.5. Conclusions
Chapter 5. Ocular Delivery of Peptides and Proteins
5.1. Introduction
5.2. The Physiology of the Eye and Challenges to the Delivery of Biomacromolecules
5.3. Considerations and Opportunities for Protein/Peptide Ocular Delivery
5.4. Peptide Transport Systems in the Eye
5.5. Strategies for the Ocular Delivery of Proteins and Peptides
5.6. Future Perspectives
Chapter 6. Brain Delivery of Peptides and Proteins
6.1. Introduction
6.2. Peptides as Drugs for the Treatment of CNS Related Disorders
6.3. Transport of Protein and Peptide Drugs to the Brain
6.4. Strategies to Enhance the Delivery of Protein/Peptide to the CNS
6.5. Conclusion
Chapter 7. Chemically Modified Polyelectrolytes for Intestinal Peptide and Protein Delivery
7.1. Introduction
7.2. Characterization of Polyelectrolyte–Protein Complexes
7.3. Types of Chemically Modified Polyelectrolytes for Protein and Peptide Delivery
7.4. Conclusion
Chapter 8. Nanoparticle Mediated Oral Delivery of Peptides and Proteins
8.1. Introduction
8.2. Biological Barriers in Oral Peptide/Protein Delivery
8.3. Approaches for Oral Peptide/Protein Delivery
8.4. Nanoparticle Based Approaches
8.5. Stability and Evaluation
8.6. Oral Delivery of Nanoparticles: Further Considerations
8.7. Bioavailability
8.8. Biocompatibility and Toxicity Issues
8.9. Conclusions
Chapter 9. Modulation of the Intestinal Tight Junctions Using Bacterial Enterotoxins
9.1. Introduction
9.2. Tight Junction Composition
9.3. Signaling Pathways Regulating tj Functions
9.4. Tight Junction Modulators
9.5. Future Perspectives
Chapter 10. Peptide and Protein Delivery with Cell-penetrating Peptides
10.1. Introduction
10.2. The Diverse Family of CPPs
10.3. Delivery of Cargoes into Cells
10.4. Penetration Versus Endocytosis
10.5. After Endocytic Entry
10.6. Moving to In Vivo Systems
10.7. Conclusions and Future Aspects
Chapter 11. Peptide and Protein Bioconjugation
11.1. Introduction: Why Bioconjugation of Peptides and Proteins?
11.2. In Vivo Behavior of PEGylated Proteins
11.3. From Random to Site-Selective PEGylation
11.4. Restoring Pharmacodynamic Properties by Reversible PEGylation
11.5. Growing-from PEGylation
11.6. Stimuli Responsive Polymers
11.7. PEGylated Pharmaceuticals on the Market
Chapter 12. Peptide and Protein Application in Tissue Repair and Regeneration
12.1. Introduction: Medical Devices
12.2. Periodontal Defects
12.3. Bone Regeneration
12.4. Surgical Procedures
12.5. Human Medicines Approved or Under Development
12.6. Future Outlook
Chapter 13. Product Quality During Manufacture and Supply
13.1. Adverse Events Caused by the Loss of Product Quality
13.2. Types of Product Quality Loss
13.3. Parameters Critical to Product Quality
13.4. Regulating Product Quality
13.5. Bioprocess Design Considerations
13.6. Conclusion
Glossary
Appendix 1. Calculated Properties of Some Clinically Relevant Peptides and Proteins
Appendix 2. Commonly Encountered Units and Abbreviations
Index