Pharmaceutical Formulation Development of Peptides and Proteins (The Taylor & Francis Series in Pharmaceutical Sciences)

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. Booknews Frokjaer, Hovgaard (pharmaceutics, Royal Danish School of Pharmacy, Denmark), and dozens of American and Danish pharmaceutical specialists discuss various aspects of peptide and protein formulation in the drug industry. Coverage includes the basics of peptide and protein production, ranging from peptide synthesis and recombinant DNA technology to protein purification; characterization and chemical stability of peptides and proteins; formulation, including solution and suspensions, as well as lyophilized peptide and protein products; a case study on drug delivery systems for alternative routes of administration; and regulatory aspects. Annotation c. Book News, Inc., Portland, OR (booknews.com) 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 proteinformulation 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 characterisation 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. 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 Peptides, which here include polypeptides and proteins, are biopolymers derived from the serial condensation of various natural amino acid monomers.