Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

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  • Edition: 2nd
  • Format: Hardcover
  • Copyright: 2012-11-14
  • Publisher: CRC Press

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Rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential poses a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. The therapeutic application of peptides and proteins is limited by several problems such as lack of physical and chemical stability and lack of optimal physic-chemical properties for adequate transport through various biomembranes. This book focuses on general pharmaceutical development aspects of peptides and proteins. It includes chapters on the immunogenicity of protein pharmaceuticals and the biosimulation of pharmacokinetics and pharmacodynamics.

Table of Contents

Prefacep. vii
Editorsp. ix
Contributorsp. xi
Peptide Synthesisp. 1
Protein Expressionp. 17
Protein Purificationp. 35
Characterization of Therapeutic Peptides and Proteinsp. 49
Chemical Pathways of Peptide and Protein Degradationp. 79
Physical Instability of Peptides and Proteinsp. 107
Peptide and Protein Derivativesp. 131
Peptides and Proteins as Parenteral Solutionsp. 149
Peptides and Proteins as Parenteral Suspensions: An Overview of Design, Development, and Manufacturing Considerationsp. 193
Rational Design of Solid Protein Formulationsp. 239
Peptide and Protein Drug Delivery Systems for Nonparenteral Routes of Administrationp. 269
Immunogenicity of Therapeutic Proteinsp. 297
Biosimulation of Peptides and Proteinsp. 323
Registration of Peptides and Proteinsp. 339
Indexp. 363
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