Pharmaceutical Formulation Development of Peptides and Proteins

Rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential pose a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. This book focuses on general pharmaceutical developmental aspects of peptides and proteins. The general principles of production, purification, degradation mechanisms, and analysis are discussed. Several chapters discuss the formulation design of peptides and proteins, including protein modification and alternative administration strategies. This second edition also includes chapters on the immunogenicity of protein pharmaceuticals and the biosimulation of pharmacokinetics and pharmacodynamics.

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product.

Providing integrated solutions, this book discusses:

• The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology
• The physicochemical characteristics and stability of peptides and proteins
• The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids
• The opportunities and challenges of non-parenteral delivery of peptides and proteins
• Risk factors, specifically the development of an unwanted immune response
• A simulation approach to describe the fate of peptides and proteins upon administration to a biological system
• The documentation required to register a protein-based drug

Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.