Photostability of Drugs and Drug Formulations, Second Edition

Photostability of Drugs and Drug Formulations, Second Edition
Author: Hanne Hjorth Tonnesen
Publisher: CRC Press
Total Pages: 450
Release: 2004-06-29
Genre: Medical
ISBN: 1420023594

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

Photostability Of Drugs And Drug Formulations

Photostability Of Drugs And Drug Formulations
Author: Hanne Hjorth Tonnesen
Publisher: CRC Press
Total Pages: 416
Release: 1996-09-03
Genre: Medical
ISBN: 074840449X

This text discusses various aspects of the combination of drugs and light. Degradation processes, stabilization of photolabile drug substances within formulations, benefits from the combination of drugs and light, and testing of drug photoreactivity, are some of the topics discussed.

Trissel's Stability of Compounded Formulations

Trissel's Stability of Compounded Formulations
Author: Lawrence A. Trissel
Publisher: American Pharmacists Association (APhA)
Total Pages: 456
Release: 2000
Genre: Medical
ISBN:

"Helps readers determine whether formulated compounds will be stable for the anticipated duration of use; properly store and repackage compounded formulations; formulate in accordance with documented standards; and, counsel patients on the use and storate of comounded medications." -- Back cover.

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing
Author: Steven W. Baertschi
Publisher: CRC Press
Total Pages: 626
Release: 2016-04-19
Genre: Medical
ISBN: 1439801800

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability

Chemical Stability of Pharmaceuticals

Chemical Stability of Pharmaceuticals
Author: Kenneth A. Connors
Publisher: John Wiley & Sons
Total Pages: 884
Release: 1986-10-13
Genre: Medical
ISBN: 9780471879558

Provides a sound theoretical basis for understanding chemical kinetics and its uses in studying drug stability. Treats the calculations, approximations, and estimates that are useful to the pharmacist in professional practice, and presents a collection of selected drug-stability data from the pharmaceutical literature. This Handbook makes accessible to the pharmacist much of the information necessary to make pharmaceutical decisions about drug stability. Changes in this edition include thorough revision of the chapter on oxidation, addition of a new chapter on solid-state stability, and a tripling of the number of stability monographs. All monographs figures have been redrawn, most of them from published data, and all sources are cited.

Pharmaceutical Formulation

Pharmaceutical Formulation
Author: Geoffrey D Tovey
Publisher: Royal Society of Chemistry
Total Pages: 432
Release: 2018-06-25
Genre: Medical
ISBN: 1849739412

Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

ICH Quality Guidelines

ICH Quality Guidelines
Author: Andrew Teasdale
Publisher: John Wiley & Sons
Total Pages: 624
Release: 2017-09-29
Genre: Medical
ISBN: 1118971132

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Chemistry and Light

Chemistry and Light
Author: Paul Suppan
Publisher: Royal Society of Chemistry
Total Pages: 323
Release: 1994
Genre: Science
ISBN: 0851868142

To provide a concise introductory overview of the various light-induced processes in physics, chemistry, biology, as well as in medicine and industry.

Pharmaceutical Photostability and Stabilization Technology

Pharmaceutical Photostability and Stabilization Technology
Author: Joseph T. Piechocki
Publisher: CRC Press
Total Pages: 445
Release: 2006-09-18
Genre: Medical
ISBN: 1420014137

Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background