Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition, 3rd Edition (Hardback) book cover

Therapeutic Peptides and Proteins

Formulation, Processing, and Delivery Systems, Third Edition, 3rd Edition

By Ajay K. Banga

CRC Press

400 pages | 24 B/W Illus.

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pub: 2015-04-23
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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

About the Author

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.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED071000
MEDICAL / Pharmacology
SCI049000
SCIENCE / Life Sciences / Biology / Molecular Biology