3rd Edition

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

By Ajay K. Banga Copyright 2015
    400 Pages 24 B/W Illustrations
    by CRC Press

    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

    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

    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.