Pharmaceutical formulation of peptides and proteins has become an important part of modern drug development. Many new drugs are based on peptide or protein recombinant technology going hand in hand with more traditional pharmaceutical formulation. In order to develop products with optimal characters, it is important to give scientists interdisciplinary knowledge and a thorough understanding of the complex nature of pharmaceutical formulation of peptides and proteins.This comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from peptide synthesis and recombinant DNA technology to protein purification. It discusses the characterization and chemical stability of peptides and proteins, before moving on to formulation, detailing peptides and proteins in solution and as suspensions, as well as lyophilized peptide and protein products. There follows a case study on drug delivery systems for alternative routes of administration. Finally, regulatory aspects are discussed in terms of chemical and pharmaceutical documentation. Each chapter is written by experts in their respective areas.Scientists in the industry and academia, and postgraduate students in pharmaceutical science will find this a valuable resource, which can be dipped in to as a reference, or studied as a whole.
Author(s): Sven Frokjaer, Lars Hovgaard
Edition: 1
Year: 1999
Language: English
Pages: 238
Book Cover......Page 1
Title......Page 4
Contents......Page 5
List of figures page......Page 12
List of tables......Page 14
Contributors......Page 16
Preface......Page 18
Peptide Synthesis......Page 20
Basics in Recombinant DNA Technology......Page 31
Protein Purification......Page 48
Peptide and Protein Characterization......Page 60
Chemical Pathways of Peptide and Protein Degradation......Page 89
Physical Stability of Proteins......Page 108
Peptides and Proteins as Parenteral Suspensions: an Overview of Design, Development, and Manufacturing Considerations......Page 132
Peptides and Proteins as Parenteral Solutions......Page 164
Roles of Protein Conformation and Glassy State in the Storage Stability of Dried Protein Formulations......Page 197
Peptide and Protein Drug Delivery Systems for Non-parenteral Routes of Administration......Page 208
Peptide and Protein Derivatives......Page 225
Chemical and Pharmaceutical Documentation......Page 239
Index......Page 251