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Pharmaceutical Book from C.H.I.P.S.

Therapeutic Peptides and Proteins
Formulation Processing and Delivery Systems
Second Edition
by Ajay K. Banga

Therapeutic Peptides and Proteins provides an understanding of protein formulation and delivery from the ground up.

Features:

  • Includes information on FDA regulatory activities in peptide- and protein-based drug research, approval, and manufacturing
  • Explores peptide- and protein-based vaccines and therapeutic agents
  • Contains hard to find practical information on protein formulation
  • Discusses recent developments such as well-characterized biologicals, statistical design for protein preformulation, and process analytical technologies
  • Covers new developments in delivery systems, including a discussion of skin microporation and pulmonary delivery

Contents

Pharmaceutical Biotechnology: The Arrival of Recombinant Proteins

  • What is Biotechnology
  • The Biotechnology Industry
  • Regulatory Aspects of Biotechnology-Derived Drugs
  • Immunogenicity of Proteins
  • Structure-Based Drug Design

Structure and Analysis of Therapeutic Peptides and Proteins

  • Amino Acids: Building Blocks of Proteins
  • Structure of Peptides and Proteins
  • Protein Conformation and Other Structural Features
  • Analytical Methods

Stability of Therapeutic Peptides and Proteins

  • Physical Instability
  • Chemical instability
  • Well-Characterized Products and Comparability Protocols

Preformulation and Formulations of Therapeutic Peptides and Proteins

  • Preformulation Studies
  • Formulation Development
  • Pharmaceutical Excipients in Formulations
  • Aggregation in Protein Formulations
  • Novel Formulation Approaches
  • Accelerated Stability Testing
  • Statistical Design for Formulation Development

Lyophilization, Pharmaceutical Processing, and Handling of Therapeutic Peptides and Protiens

  • Protein Destabilization Induced by Pharmaceutical Processing
  • Lyophilization as a Pharmaceutical Process
  • Alternative Pharmaceutical Processes
  • Handling of Therapeutic Peptides and Proteins

Parenteral Controlled Delivery and Pharmacokinetics of Therapeutic Peptides and Proteins

  • Pharmacokinetics of Peptide and Protein Drugs
  • Polymers Used for Controlled Delivery of Peptides and Proteins
  • Parenteral Controlled Release Systems
  • Innovations in Parenteral Administration of Proteins
  • Examples of Protein Pharmacokinetics

Oral Delivery of Peptide and Protien Drugs

  • Barriers to Protein Absorption and Pathways of Penetration
  • Approaches to Improve Oral Delivery
  • Methods to Study Oral Absorption
  • Oral Immunization

Transdermal and Topical Delivery of Therapeutic Peptides and Proteins

  • Skin Structure
  • Approaches to Enhance Transdermal Peptide Delivery
  • Iontophoresis
  • Topical Delivery of Therapeutic Peptides and Proteins

Pulmonary and Other Mucosal Delivery of Therapeutic Peptides and Proteins

  • Pulmonary Delivery
  • Nasal Delivery
  • Rectal Delivery
  • Buccal Delivery
  • Ocular Delivery
  • Comparative Evaluation of Mucosal Routes

Recombinant Protein Subunit Vaccines and Delivery Methods

  • Immunology Relevant to Vaccines
  • Routes of Administration
  • Delivery Approaches for Administration of Vaccines
  • Case example: Hepatitis B

Index

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Therapeutic Peptides and Proteins
Formulation Processing and Delivery Systems
Second Edition
by Ajay K. Banga

2005 376 pages $198.95 + shipping
Texas residents please add 6.75 % sales tax

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