Photostability of Drugs and Drug Formulations, Second Edition

Front Cover
Hanne Hjorth Tonnesen
CRC Press, Jun 29, 2004 - Medical - 448 pages
Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource.

The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results.

Features
  • Assists non-experts in this field design a test protocol and interpret the results
  • Covers in vitro and in vivo aspects of interactions between drugs and light
  • Explores the kinetic and chemical aspects of drug photodecomposition
  • Discusses the problems frequently encountered in photochemical stability testing
  • Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs
  • Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint
  • Offers specific guidance in photostability testing and screening of drug photoreactivity
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    Contents

    Chapter 2 Photophysical and Photochemical Aspects of Drug Stability
    9
    Chapter 3 Standardization of Kinetic Studies of Photodegradation Reactions
    41
    Chapter 4 Rationalizing the Photochemistry of Drugs
    67
    Chapter 5 Technical Requirements and Equipment for Photostability Testing
    111
    Design and Interpretation of Tests on New Drug Substances and Dosage Forms
    137
    Chapter 7 The Questions Most Frequently Asked
    161
    Chapter 8 Inconsistencies and Deficiencies in Current Official Regulations Concerning Photolytic Degradation of Drugs
    173
    Chapter 9 Biological Effects of Combinations of Drugs and Light
    189
    Chapter 12 Photochemical and Photophysical Methods Used in Study of Drug Photoreactivity
    255
    Chapter 13 Addressing the Problem of Light Instability during Formulation Development
    285
    Chapter 14 Photostability of Parenteral Products
    303
    Chapter 15 Photoactivated Drugs and Drug Formulations
    331
    Chapter 16 Formulation Approaches for Improving Solubility and Its Impact on Drug Photostability
    351
    Useful Terms and Expressions in the Photoreactivity Testing of Drugs
    373
    Relevant Literature on the Photostability of Specific Drug Substances and Drug Formulations
    377
    Index
    415

    A Test Case
    213
    Chapter 11 Screening Dyes Drugs and Dietary Supplements for Ocular Phototoxicity
    235
    Back cover
    437
    Copyright

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