Pharmaceutical Dissolution Testing

Offering contributions by leading FDA and USP scientists, as well as the editor of Dissolution Technologies, this referencecontains a detailed overview of the history of dissolution testing provides a comprehensive layout of the available testing equipment-offering photographs and diagrams of each device, as well as troubleshooting procedures for difficult situationsdiscusses the compendial requirements of dissolution testing, including a comparison of the three most used pharmacopoeia from the United States, Europe, and Japanfocuses on the application of dissolution testing to the quality control of drug productsaddresses practical issues in the design of dissolution tests in the industrial arena-covering subjects such as selection of key operating parameters, the choice of sampling times, method optimization, and analytical considerations such as linearity, precision, specificity, and ruggedness, with an entire chapter devoted to automation of dissolution testsintroduces the latest thinking on biorelevant dissolution testing and its application to both immediate and controlled-release dosage formsincludes a discussion of the impact of the FDA on dissolution testingutilizes practical examples to showcase IVIVC relationships An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.