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Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptides, proteins, and nucleic acid-based drugs or vaccines related to the site of administration and the target site. Many of the approaches described are reported in formulations in current clinical trials as well as in marketed products. Contents include:
challenges in delivery of biopharmaceuticals
novel formulation approaches for peptide and protein injectables
non-viral chemical vectors and viral technology for delivery of nucleic acid based drugs
immune response, adjuvants and delivery systems for vaccines
several examples of delivery systems for different biopharmaceuticals
a critical assessment of delivery technologies for biopharmaceuticals
Delivery Technologies for Biopharmaceuticals is an essential single-volume introduction to the technologies used by researchers to ensure efficient delivery of this exciting new class of drugs. It will be of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development.
Contents
Preface. List of Contributors.
INTRODUCTION.
1. Challenges in Delivery of Biopharmaceuticals; the Need for Advanced Delivery Systems (Hanne Mørck Nielsen and Lene Jorgensen).
1.1 Introduction.
1.2 Overcoming Delivery Barriers.
1.3 Drug Delivery Technologies and Excipients.
1.4 Risks.
1.5 Conclusion.
References.
DELIVERY OF BIOPHARMACEUTICALS.
2. Novel Formulation Approaches for Peptide and Protein Injectables (Mingshi Yang and Sven Frokjaer).
2.1 Introduction.
2.2 Formulation Challenges.
2.3 Chemical Modification of Proteins and Peptides.
2.4 Depot Delivery Systems.
2.5 Other Delivery Systems.
2.6 Conclusions.
References.
3. Novel Non-Injectable Formulation Approaches of Peptides and Proteins (Shirui Mao, Dongmei Cun and Yoshiaki Kawashima).
3.1 Introduction.
3.2 Intranasal Delivery of Peptide/Protein Drugs.
3.3 Pulmonary Delivery of Peptide/Protein Drugs.
3.4 Buccal Administration of Peptide/Protein Drugs.
3.5 Oral Delivery of Peptide/Protein Drugs.
3.6 Transdermal Delivery of Peptide/Protein Drugs.
3.7 Conclusions.
References.
4. Chemical Vectors for Delivery of Nucleic Acid-Based Drugs (Elizabeth A. Vasievich and Leaf Huang).
4.1 Introduction.
4.2 Barriers to Delivery of Nucleic Acids.
4.3 Major Classes of Delivery Vectors.
4.4 Targeted Delivery.
4.5 Triggered Release.
4.6 Recent Clinical Trials Using Naked and Chemically Complexed Nucleic Acids.
4.7 Conclusion.
References.
5. Viral Technology for Delivery of Nucleic Acids (Shervin Bahrami and Finn Skou Pedersen).
5.1 Introduction.
5.2 Barriers and Topological Requirements to Cellular Entry.
5.3 Routes of Administration.
5.4 Delivery Vector Requirements.
5.5 Examples of Viral Delivery Technology.
5.6 Conclusion.
References.
6. The Innate Immune Responses, Adjuvants and Delivery Systems (S. Moein Moghimi).
6.1 Introduction.
6.2 Dendritic Cell Immunobiology.
6.3 Antigen Capture.
6.4 Particulate Antigen Delivery Systems.
6.5 Signalling Receptors and the Role of Adjuvants.
6.6 Conclusions.
References.
DELIVERY TECHNOLOGIES FOR BIOPHARMACEUTICALS.
7. Lipid Nanoparticle-Based Systems for Delivery of Biomacromolecule Therapeutics (Susana Martins, Domingos C. Ferreira and Eliana B. Souto).
7.1 Introduction.
7.2 Definitions and Properties of Solid Lipid Nanoparticles (SLNs).
7.3 Definitions and Properties of Lipid-Drug Conjugates (LDCs).
7.4 Administration, Delivery and Targeting.
7.5 Toxicity and Safety.
7.6 Applications for Biopharmaceuticals.
7.7 Conclusions.
References.
8. Dendrimers in Delivery of Biopharmaceuticals (Chandan Thomas and Fakhrul Ahsan).
8.1 Introduction.
8.2 Case I -- Application of Dendrimers in Delivery of Large Molecular Weight Drugs.
8.3 Case II -- Application of Dendrimers in Gene Delivery.
8.4 Case III -- Application of Dendrimers in Vaccine Delivery.
8.5 Concluding Remarks.
References.
PEPTIDES AND PROTEINS.
9. Modifi cation of Peptides and Proteins (Susanne Hostrup, Kasper Huus and Henrik Parshad).
9.1 Introduction.
9.2 PEGylated Peptides and Proteins.
9.3 Lipidization of Peptides and Proteins.
9.4 Modification of the Primary Structure of Peptides and Proteins.
9.5 General Considerations on Processing and Characterization.
9.6 Conclusions.
References.
10. Nanocarriers for the Delivery of Peptides and Proteins (Kenneth Lundstrom).
10.1 Introduction.
10.2 Polymeric Nanoparticles.
10.3 In Situ Depot Forming Systems.
10.4 Conclusions.
References.
11. Polymer-Based Delivery Systems for Oral Delivery of Peptides and Proteins (Bruno Sarmento, Domingos Ferreira and Teófi lo Vasconcelos).
11.1 Introduction.
11.2 Advances in Oral Protein Delivery.
11.3 Intestinal Considerations for Protein Absorption.
11.4 Polymer-Based Delivery Systems for Oral Delivery of Proteins.
11.5 Conclusions.
References.
12. Advanced Pulmonary Delivery of Peptides or Proteins Using Polymeric Particles (Yu Seok Youn, Kang Choon Lee, You Han Bae, Kun Na and Eun Seong Lee).
12.1 Introduction.
12.2 Practical Issues in the Pulmonary Delivery of Peptides and Proteins.
12.3 Polymeric Microparticles for Delivering Peptides and Proteins.
12.4 Porous Microparticles.
12.5 Polymeric Nanoparticles.
12.6 Sustained or Controlled Release Issues in Polymeric Particle Formulations.
12.7 Stability Issues of Peptides and Proteins in Particles.
12.8 Toxicity Issues of Inhaled Particles.
12.9 Conclusions.
References.
NUCLEIC ACIDS.
13. Polymer Microparticles for Nucleic Acid Delivery (Tim Pearce, Jared Hierman and Chun Wang).
13.1 Introduction.
13.2 Microparticles Based on Poly(Lactic-co-Glycolic Acids) (PLGA).
13.3 Other Types of Polymer Microparticles.
13.4 Conclusions.
References.
14. Pulmonary Delivery of Small Interfering RNA for Novel Therapeutics (Qing Ge, David Evans, John J. Xu, Harry H. Yang and Patrick Y. Lu).
14.1 Introduction.
14.2 RNA Interference: Mechanism of Action.
14.3 Lung Physiology.
14.4 Animal Models.
14.5 siRNA Delivery to Treat Pulmonary Diseases.
14.6 siRNA-Induced Infl ammatory Response.
14.7 Case Studies.
14.8 Faster Drug for Unknown Bugs.
14.9 Conclusions.
References.
15. Lipid-Based Formulations for siRNA Delivery (Camilla Foged, Pieter Vader and Raymond M. Schiffelers).
15.1 Introduction.
15.2 Cationic Lipid-Based Delivery Systems for Nucleic Acid-Based Drugs.
15.3 Neutral and Anionic Lipid-Based Drug Delivery Systems.
15.4 Mechanisms of Internalization.
15.5 Immune Activation.
15.6 Conclusions.
References.
16. Cellular Bioavailability of Peptide Nucleic Acids (PNAs) Conjugated to Cell Penetrating Peptides (Takehiko Shiraishi and Peter E. Nielsen).
16.1 Introduction.
16.2 Peptide Nucleic Acids (PNAs).
16.3 Cell Penetrating Peptides (CPPs).
16.4 Cellular Uptake Versus Bioavailability.
16.5 PNA Conjugates.
16.6 Efficacy Versus Effi ciency.
16.7 Auxiliary Agents.
16.8 In Vivo Activity of PNA Conjugates.
16.9 Conclusions.
References.
17. DEAE-dextran-MMA Graft Copolymer for Non-Viral Delivery of DNA (Yasuhiko Onishi, Yuki Eshita and Masaaki Mizuno).
17.1 Introduction.
17.2 Theoretical.
17.3 Materials and Methods.
17.4 Conclusions.
References.
VACCINES.
18. Liposomes in Adjuvant Systems for Parenteral Delivery of Vaccines (Dennis Christensen, Karen Korsholm, Grith Krøyer Wood, Afzal Mohammed, Vincent Bramwell, Peter Andersen, Else Marie Agger and Yvonne Perrie).
18.1 The Structural Basis of Liposomes.
18.2 Key Characteristics Which Make Liposomes Advantagous as Vaccine Delivery Systems.
18.3 Formulation Approaches to Improve Adjuvanticity and Enhance Immunological Targeting.
18.4 Instability Considerations of Liposomes.
18.5 Techniques to Formulate Long-Term Stable Liposome Formulations.
18.6 Conclusion.
References.
19. Influenza Virosomes as Delivery Systems for Antigens (Mario Amacker, Stefan Moese, Andreas R. Kammer, Ari Helenius and Rinaldo Zurbriggen).
19.1 Introduction.
19.2 A Case Study -- Antigen-Virosome Drug Delivery System.
19.3 Methods.
References.
20. GRAZAX: An Oromucosal Vaccine for Treating Grass Pollen Allergy with Immunotherapy (Annette Römmelmayer Lundegaard, Lise Lund and Jørgen Nedergaard Larsen).
20.1 Introduction.
20.2 Specific Immunotherapy.
20.3 Description of Grass Pollen Extract.
20.4 Technologies of Fast Dissolving Tablets.
20.5 Formulation of GRAZAX.
20.6 Production of GRAZAX.
20.7 Specifications and Analytical Procedures.
20.8 Feasibility Study: Additional Analyses.
20.9 Conclusions.
References.
FINAL COMMENTS.
21. Delivery Technologies for Biopharmaceuticals: A Critical Assessment (Marco van de Weert).
21.1 Introduction.
21.2 Large Scale Production and Reproducibility.
21.3 Safety Concerns.
21.4 Cost-Benefit Ratio.
21.5 Conclusion.
References.
Index.
