3rd Edition

Therapeutic Peptides and Proteins
Formulation, Processing, and Delivery Systems, Third Edition




ISBN 9781466566064
Published April 23, 2015 by CRC Press
400 Pages 24 B/W Illustrations

USD $210.00

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Book Description

There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis.

The clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable, and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, microbiology, and chemical engineering and needs to keep abreast with the latest research in the published literature.

Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition provides a comprehensive overview of the field for scientists in industry and academia and for students, while also providing practical information on the challenges facing the formulation and delivery aspects of these unique macromolecules. In particular, the book:

  • Explains how recombinant DNA techniques now allow us to produce therapeutic proteins in a commercially viable form
  • Discusses the physical and chemical pathways of peptide and protein degradation
  • Includes a detailed discussion of protein formulation and lyophilization
  • Overviews the pharmacokinetic aspects of therapeutic peptides and proteins and discusses controlled delivery systems for parenteral administration, including microsphere formulations
  • Discusses research progress on oral, transdermal, mucosal, and topical delivery systems discusses transdermal and topical delivery

Table of Contents

FORMULATION AND PROCESSING
Pharmaceutical Biotechnology: The Arrival of Recombinant Proteins
What Is Biotechnology?
Biotechnology Industry
Regulatory Aspects of Biotechnology-Derived Drugs
Immunogenicity of Proteins
Structure-Based Drug Design
Conclusions
References
Structure and Analysis of Therapeutic Peptides and Proteins
Amino Acids: Building Blocks of Proteins
Structure of Peptides and Proteins
Protein Conformation and Other Structural Features
Analytical Methods
Conclusions
References
Stability of Therapeutic Peptides and Proteins
Introduction
Physical Instability
Chemical Instability
Biosimilars and Comparability Protocols
Conclusions
References
Preformulation and Formulation of Therapeutic Peptides and Proteins
Introduction
Preformulation Studies
Formulation Development
Pharmaceutical Excipients in Formulations
Aggregation in Protein Formulations
Novel Formulation Approaches
Accelerated Stability Testing
Quality by Design for Formulation Development
Conclusions
References
Lyophilization, Pharmaceutical Processing, and Handling of Therapeutic Peptides and Proteins
Introduction
Protein Destabilization Induced by Pharmaceutical Processing
Lyophilization as a Pharmaceutical Process
Alternative Pharmaceutical Processes
Handling of Therapeutic Peptides and Proteins
Conclusions
References

DRUG DELIVERY SYSTEMS
Parenteral Controlled Delivery and Pharmacokinetics of Therapeutic Peptides and Proteins
Introduction
Pharmacokinetics of Peptide and Protein Drugs
Polymers Used for Controlled Delivery of Peptides and Proteins
Parenteral Controlled-Release Systems
Innovations in Parenteral Administration of Proteins
Examples of Protein Pharmacokinetics
Conclusions
References
Oral Delivery of Peptide and Protein Drugs
Introduction
Barriers to Protein Absorption and Pathways of Penetration
Approaches to Improve Oral Delivery
Methods to Study Oral Absorption
Oral Immunization
Conclusions
References
Transdermal and Topical Delivery of Therapeutic Peptides and Proteins
Introduction
Approaches to Enhance Transdermal Peptide Delivery
Iontophoresis
Topical Delivery of Therapeutic Peptides and Proteins
Conclusions
References
Pulmonary and Other Mucosal Delivery of Therapeutic Peptides and Proteins
Introduction
Pulmonary Delivery
Nasal Delivery
Rectal Delivery
Buccal Delivery
Ocular Delivery
Comparative Evaluation of Mucosal Routes
Conclusions
References
Recombinant Protein Subunit Vaccines and Delivery Methods
Introduction
Immunology Relevant to Vaccines
Routes of Administration
Delivery Approaches for Administration of Vaccines
Case Example: Hepatitis B
Future Outlook and Regulatory Status
Conclusions
References

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Author(s)

Biography

Ajay K. Banga is a professor and chair of the Department of Pharmaceutical Sciences at the College of Pharmacy and Health Sciences, Mercer University, Atlanta, Georgia. He obtained a PhD in pharmaceutics from Rutgers University, New Jersey. Dr. Banga is currently a major advisor to eight PhD students. He currently serves on the editorial board of eight journals and has also served as the Editor-in-Chief for one drug delivery journal. He has served on over 30 thesis/dissertation advisory committees and as a referee for more than 28 journals. Dr. Banga is a fellow of the American Association of Pharmaceutical Scientists. He has written more than 220 publications and scientific abstracts.