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Therapeutic Peptides and Proteins

Formulation, Processing, and Delivery Systems, Second Edition

By Ajay K. Banga

Published September 14th 2005 by CRC Press – 376 pages

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Description

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up-to-date, relevant information on protein formulation and/or delivery systems and the need for a new edition is self-evident. This second edition continues the tradition of providing a ready-to-use reference of accurate information, tables, and illustrations.

The book begins with the basics of the origin of recombinant proteins, explores structural and analytical aspects, and moves on to discuss the stability of proteins and peptides. Against this background, the author addresses preformulation and formulation considerations and provides detailed information on important topics such as lyophilization. He goes on to discuss various delivery systems, including controlled release delivery systems and products currently on the market. The book also contains newly added regulatory information and thoroughly investigates therapeutic drugs made from proteins as well as protein-based vaccines. A new chapter on recombinant protein subunit vaccines and their delivery systems has been added.

The work of a single author, the book provides complex information in a simple, elegant, and cohesive style. The author minimizes overlap between coverage and includes extensive cross-referencing that links related topics. Completely revised and updated, packed with cutting-edge information, the second edition once again fills the need for a reference that pulls all the relevant information together into one resource.

Reviews

“The book begins with the basics of the origin for recombinant proteins, explores structural and analytical aspects, and moves on to discuss the stability of proteins and peptides. … The book also contains newly added regulatory information and thoroughly investigates therapeutic drugs made form proteins as well as protein-based vaccines. A new chapter on recombinant protein subunit vaccines and their delivery systems has been added. … the book provides complex information in a simple, elegant, uniform style. … includes extensive cross-referencing that directs the reader to relevant parts of the book for related topics. Completely revised and updated, the second edition once again fills the need for a reference that pulls all the relevant information together into one resource.”

— In Anticancer Research, Vol. 26, 2006

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

Conclusions

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

Conclusions

Stability of Therapeutic Peptides and Proteins

Introduction

Physical Instability

Chemical instability

Well-Characterized Products and Comparability Protocols

Conclusions

Preformulation and Formulation of Therapeutic Peptides and Proteins

Introduction

Preformulation Studies

Formulation Development

Pharmaceutical Excipients in Formulations

Aggregation in Protein Formulations

Novel Formulation Approaches

Accelerated Stability Testing

Statistical Design for Formulation Development

Conclusions

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

Introduction

Protein Destabilization Induced by Pharmaceutical Processing

Lyophilization as a Pharmaceutical Process

Alternative Pharmaceutical Processes

Handling of Therapeutic Peptides and Proteins

Conclusions

Parenteral Controlled Delivery and Pharmacokinetics of Therapeutic Peptides and Proteins

Introduction

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

Conclusions

Oral Delivery of Peptide and Protein Drugs

Introduction

Barriers to Protein Absorption and Pathways of Penetration

Approaches to Improve Oral Delivery

Methods to Study Oral Absorption

Oral Immunization

Conclusions

Transdermal and Topical Delivery of Therapeutic Peptides and Proteins

Introduction

Skin Structure

Approaches to Enhance Transdermal Peptide Delivery

Iontophoresis

Topical Delivery of Therapeutic Peptides and Proteins

Conclusions

Pulmonary and Other Mucosal Delivery of Therapeutic Peptides and Proteins

Introduction

Pulmonary Delivery

Nasal Delivery

Rectal Delivery

Buccal Delivery

Ocular Delivery

Comparative Evaluation of Mucosal Routes

Conclusions

Recombinant Protein Subunit Vaccines and Delivery Methods

Introduction

Immunology Relevant to Vaccines

Routes of Administration

Delivery Approaches for Administration of Vaccines

Case example: Hepatitis B

Future Outlook and Regulatory Status

Conclusions

Name: Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Second Edition (Hardback) – CRC Press 
Description: By Ajay K. Banga. Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would...
Categories: Biotechnology, Pharmaceutical Science, Molecular Biology