Peptide and Protein Drug Delivery

edited by Vincent H.L. Lee

The first comprehensive survey of peptide and protein drugs, this valuable reference/text covers fundamentals of peptide and protein drug delivery, including such major considerations as:

• Synthesis, physical chemistry and biochemistry, analysis, proteolytic and transport constraints, pharmacokinetics, and pharmacodynamics

• Bioavailability from routes of administration, detailing parenteral, buccal, rectal, nasal, vaginal, transdermal, and oral methods

• Practical issues of drug delivery, such as formulation challenges, mucosal dosage forms, controlled delivery systems, toxicology, immunology, quality assurance, and regulatory aspects

Peptide and Protein Drug Delivery also:

• Discusses methods and the rationale of protein and peptide synthesis
• Identifies unique analytical challenges in detecting these drugs in formulations and biological fluids
• Demonstrates the role of protease inhibitors and penetration enhancers in delivery systems
• Considers various approaches to controlling drugs' rate and duration of release
• Examines questions associated with peptide and protein drug delivery and assessment
• And much more!

Featuring more than 250 diagrams, tables, and photographs, plus some 2,000 citations of pertinent literature, Peptide and Protein Drug Delivery is an essential reference for pharmaceutical scientists, pharmacologists, biotechnologists, medicinal and analytical chemists, biochemists, toxicologists, molecular biologists, and government regulatory personnel, as well as an outstanding text for graduate courses in pharmacy, medicinal and protein chemistry, or molecular biology.

Contents

1. Fundamentals
   1. Changing Needs in Drug Delivery in the Era of Peptide and Protein Drugs
   2. Synthesis of Peptides and Proteins by Chemical and Biotechnological Means
   3. Physical Biochemistry of Peptide Drugs: Structure, Properties, and Stabilities of Peptides Compared with Proteins
   4. Physical Biochemistry of Protein Drugs
   5. Approaches to the Analysis of Peptides
   6. Analysis of Protein Drugs
   7. Enzymatic Barriers to Peptide and Protein Drug Delivery
   8. Intestinal Epithelial and Vascular Endothelial Barriers to Peptide and Protein Delivery
   9. Pharmacokinetics of Peptide and Protein Drugs

2. Routes of Delivery
   10. Parenteral Delivery of Peptide and Protein Drugs
   11. Buccal Routes of Peptide and Protein Drug Delivery
   12. Rectal Route of Peptide and Protein Drug Delivery
   13. Nasal Route of Peptide and Protein Drug Delivery
   14. Vaginal Route of Peptide and Protein Drug Delivery
   15. Transdermal Route of Peptide and Protein Drug Delivery
   16. Oral Route of Peptide and Protein Drug Delivery

3. Practical Considerations
   17. Mucoadhesive Dosage Forms for Peptide and Protein Drug Delivery
   18. Preformulation and Formulation Considerations of Peptide Drugs: Case History of an LHRH Analog
   19. Controlled Delivery Systems for Peptides
   20. Characterization of the Toxicity Profile of Peptide and Protein Therapeutics
   21. Reduction of Immunogenicity and Extension of Circulating Half-Life of Peptides and Proteins
   22. Regulatory Perspective of Peptide and Protein Drug Development

Index

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