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Therapeutic Peptides and Proteins

Formulation, Process and Development Systems

(Autor)

Buch | Hardcover
317 Seiten
1997
Technomic Publishing Co (Verlag)
978-1-56676-329-5 (ISBN)
119,95 inkl. MwSt
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From the Preface

At the time of this writing, the American biotechnology and pharmaceutical industry has more than two dozen biotechnology-derived therapeutic proteins on the market, while several hundred are in various stages of human clinical trials or at the FDA for review. Today, more than a thousand companies are involved in biotechnology research, with a total revenue of $7.7 billion for 1993. Therapeutic peptides and proteins are expected to mitigate suffering in coming years as anticancer agents, hormones, growth factors, analgesics, anti-hypertensives, and thrombolytics, among others. However, the clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, and microbiology, and needs to keep abreast with the latest research in the published literature. This book presents these principles in a simple, interesting and practically useful manner for the benefit of scientists working in this area and to further research in this area. This book will also provide useful information for students and academic researchers and add to their interest in this area. The book should also be useful in a hospital setting to understand potential physicochemical stability problems that may result during reconstitution or administration of the new recombinant proteins. Since this field is relatively new and rapidly evolving, efforts were made to include very recent literature in the book. As a result, over 40% of the literature citations in the book are for the work published in the last two years.

Preface

Part I: Formulation and Processing

Pharmaceutical Biotechnology: The Arrival of Recombinant Proteins
Introduction - What is Biotechnology? - The Biotechnology Industry - Regulatory Aspects of Biotechnology-Derived Drugs - Structure-Based Drug Design - Conclusions - References
Structure and Analysis of Therapeutic Peptides and Proteins
Introduction - Amino Acids: Building Blocks of Proteins - Structure of Peptides and Proteins - Protein Conformation and Other Structural Features - Analytical Methods - Conclusions - References
Stability of Therapeutic Peptides and Proteins
Introduction - Physical Instability - Chemical Instability - Conclusions - References
Formulation of Therapeutic Peptides and Proteins
Introduction - Formulation Development - Pharmaceutical Excipients in Formulations - Aggregation in Protein Formulations - Novel Formulation Approaches - Accelerated Stability Testing - Conclusions - References
Pharmaceutical Processing and Handling of Therapeutic Peptides and Proteins
Introduction - Protein Destabilization Induced by Pharmaceutical Processing - Lyophilization as a Pharmaceutical Process - Alternate Pharmaceutical Processes - Handling of Therapeutic Peptides and Proteins - Conclusions - References

Part II: Drug Delivery Systems


Pharmacokinetics of Peptide and Protein Drugs
Introduction - Pharmacokinetic Parameters - Examples of Protein Pharmacokinetics - Other Pharmacokinetic/Pharmacodynamics Considerations - Transport of Peptides Across the Blood-Brain Barrier - Conclusions - References
Parenteral Controlled Delivery of Therapeutic Peptides and Proteins
Introduction - Polymers Used for Controlled Delivery of Peptides and Proteins - Parenteral Controlled Release Systems - Conclusions - References
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 - References
Transdermal and Topical Delivery of Therapeutic Peptides and Proteins
Introduction - Approaches to Enhance Transdermal Peptide Delivery - Iontophoresis - Topical Delivery of Therapeutic Peptides and Proteins - Conclusions - References
Mucosal Delivery of Therapeutic Peptides and Proteins
Introduction - Nasal Delivery - Pulmonary Delivery - Rectal Delivery - Buccal Delivery - Ocular Delivery - Comparative Evaluation of Mucosal Routes - Conclusions - References

Index

Erscheint lt. Verlag 1.7.1997
Verlagsort Lancaster
Sprache englisch
Gewicht 694 g
Themenwelt Naturwissenschaften Biologie Biochemie
ISBN-10 1-56676-329-0 / 1566763290
ISBN-13 978-1-56676-329-5 / 9781566763295
Zustand Neuware
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