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

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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.