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.

Pharmaceutical Crystals

Pharmaceutical Crystals
Author: Tong Li
Publisher: John Wiley & Sons
Total Pages: 432
Release: 2018-10-16
Genre: Science
ISBN: 1119046297

An important resource that puts the focus on understanding and handling of organic crystals in drug development Since a majority of pharmaceutical solid-state materials are organic crystals, their handling and processing are critical aspects of drug development. Pharmaceutical Crystals: Science and Engineering offers an introduction to and thorough coverage of organic crystals, and explores the essential role they play in drug development and manufacturing. Written contributions from leading researchers and practitioners in the field, this vital resource provides the fundamental knowledge and explains the connection between pharmaceutically relevant properties and the structure of a crystal. Comprehensive in scope, the text covers a range of topics including: crystallization, molecular interactions, polymorphism, analytical methods, processing, and chemical stability. The authors clearly show how to find solutions for pharmaceutical form selection and crystallization processes. Designed to be an accessible guide, this book represents a valuable resource for improving the drug development process of small drug molecules. This important text: Includes the most important aspects of solid-state organic chemistry and its role in drug development Offers solutions for pharmaceutical form selection and crystallization processes Contains a balance between the scientific fundamental and pharmaceutical applications Presents coverage of crystallography, molecular interactions, polymorphism, analytical methods, processing, and chemical stability Written for both practicing pharmaceutical scientists, engineers, and senior undergraduate and graduate students studying pharmaceutical solid-state materials, Pharmaceutical Crystals: Science and Engineering is a reference and textbook for understanding, producing, analyzing, and designing organic crystals which is an imperative skill to master for anyone working in the field.

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)

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
Total Pages: 389
Release: 2008-11-16
Genre: Medical
ISBN: 0387856277

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Photostabilization of Polymers

Photostabilization of Polymers
Author: J.F. Rabek
Publisher: Springer Science & Business Media
Total Pages: 607
Release: 2012-12-06
Genre: Science
ISBN: 9400907478

During the last two decades, the production of polymers and plastics has been increasing rapidly. In spite of developing new polymers and polymeric materials, only 40-60 are used commercially on a large scale. It has been estimated that half of the annual production of polymers is employed outdoors. Increasing the stability of polymers and plastics towards heat, light, atmospheric oxygen and other environmental agents and weathering conditions has always been a very important problem. The photochemical instability of most of polymers limits them to outdoor application, where they are photo degraded fast over periods ranging from months to a few years. To the despair of technologists and consumers alike, photodegrada tion and environmental ageing of polymers occur much faster than can be expected from knowledge collected in laboratories. In many cases, improved methods of preparation and purification of both monomers and polymers yield products of better quality and higher resistance to heat and light. However, without stabilization of polymers by applica tion of antioxidants (to decrease thermal oxidative degradation) and photostabilizers (to decrease photo-oxidative degradation) it would be impossible to employ polymers and plastics in everyday use.

Drug Stability and Chemical Kinetics

Drug Stability and Chemical Kinetics
Author: Muhammad Sajid Hamid Akash
Publisher: Springer Nature
Total Pages: 284
Release: 2020-11-01
Genre: Medical
ISBN: 9811564264

This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of reactions, types of degradation and how to prevent it, as well as types of stability studies. It also offers insights into the importance of the rate at which the drug is degraded and/or decomposed under various external and internal conditions, including temperature, pH, humidity and light. This book is intended for researchers, PhD students and scientists working in the field of pharmacy, pharmacology, pharmaceutical chemistry, medicinal chemistry and biopharmaceutics.

The Syringe Driver

The Syringe Driver
Author: Andrew Dickman
Publisher: Oxford University Press
Total Pages: 609
Release: 2016
Genre: Medical
ISBN: 0198733720

This book serves as a valuable reference source, providing a comprehensive review of syringe driver use and administration of drugs via CSCI, a safe and effective way of drug administration when other routes are inappropriate.

Stability of Drugs and Dosage Forms

Stability of Drugs and Dosage Forms
Author: Sumie Yoshioka
Publisher: Springer Science & Business Media
Total Pages: 274
Release: 2007-05-08
Genre: Medical
ISBN: 0306468298

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.

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.