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Practical Aspects of Hyaluronan Based Medical Products




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ISBN 9780849333248
Published September 23, 2005 by CRC Press
240 Pages - 52 B/W Illustrations

 
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Book Description

The ballooning body of research devoted to hyaluronan (HA) reflects its enormous potential for various medical applications. There have been many successes of varying degrees in the development of medical products based on HA, but also some setbacks. While there is obviously ample information available on the chemistry and various properties of this macromolecule, Practical Aspects of Hyaluronan Based Medical Products is the first book devoted to systematically applying this knowledge to product development.

Based on the author's extensive experience working with HA, this book explores in detail the chemistry, composition, formulation, testing, safety, effectiveness, quality control, and regulatory approval of HA medical products. It begins with a survey of the historical development and recent products based on hyaluronan. Subsequent chapters detail the rheological properties of the molecule and explore the chemical principles and methods forming the technical basis of product development, illustrated by more than 50 figures of chemical structures, reaction schemes, and rheological properties. Individual chapters then consider standards, tests, and analytical methods; safety of HA-based products for their indicated applications; and clinical performance, mechanism of action, and product characteristics.

Practical Aspects of Hyaluronan Based Medical Products surveys FDA review documents as well as peer-reviewed journal articles to identify the elements essential to successful product development, namely, understanding the critical issues in the regulatory path and linking clinical performance of the products to their original design.

Table of Contents

OVERVIEW
Discovery
Primary Structure
Molecular Formula
Member of Glycosaminoglycans
HA Structures of Higher Orders
Viscosity, Molecular Weight, and Structures
Source and Isolation
Distribution and Catabolism
Influence on Cell Behavior
Chemical Modification
HA-Based Medical Products
Ever-Growing Interest
References
CHEMISTRY
Chemistry in Structural Investigation
Chromogenic Reactions
Chemistry of HA Degradation
Chemistry in Isotopic Labeling
Synthesis of Fluorescent HA
Biotinylated HA
HA Derivatives with Various Side Chains
HA-Drug Conjugation
Chemical Crosslinking of HA
Preparation of Oligosaccharides
Sulfation of HA
Summary of Methods of Chemical Modification
References
RHEOLOGICAL PROPERTIES OF HYALURONAN AS RELATED TO ITS STRUCTURE, SIZE, AND CONCENTRATION
Some Basic Concepts of Intrinsic Viscosity
Hydrodynamic Volume and Molecular Structures
Absolute Viscosity Measured at Steady State
Viscoelasticity
References
STANDARDS, TESTS, AND ANALYTICAL METHODS
Standards and Specifications
Analyses of HA Structure, Size, and Quantity
Natural Polymeric Impurities
Other Bioassays
Lipoteichoic Acid
Chemical Methods of Radiolabeling
References
SAFETY OF HYALURONAN-BASED MEDICAL PRODUCTS IN THEIR INDICATED APPLICATIONS
General Safety Considerations
Safety Information from Specific Human Use
References
CLINICAL PERFORMANCE, MECHANISM OF ACTION, AND PRODUCT CHARACTERISTICS
Ophthalmic Surgeries
Injections for Osteoarthritic Knees
Adhesion Prevention and Wound Healing
Tissue Augmentation
Dental and Bone Application
References
INDEX

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