Pharmaceutical Dissolution Testing offers an expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms

Features:

• Contains 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 situations
• Discusses the compendial requirements of dissolution testing, including a comparison of the three most used pharmacopoeia from the United States, Europe, and Japan
• Focuses on the application of dissolution testing to the quality control of drug products
• Addresses 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 tests
• Introduces the latest thinking on biorelevant dissolution testing and its application to both immediate and controlled-release dosage forms
• Includes a discussion of the impact of the FDA on dissolution testing
• Utilizes practical examples to showcase IVIVC relationships

Contents

• Historical Development of Dissolution Testing
• Compendial Testing Equipment: Calibration, Qualification, and Sources of Error
• Compendial Requirements of Dissolution Testing
• The Role of Dissolution Testing in the Regulation of Pharmaceuticals: The FDA Perspective
• Physiological Parameters Relevant to Dissolution Testing: Composition of Fluids in the GI Tract
• Physiological Parameters Relevant to Dissolution Testing: Hydrodynamic Considerations
• Physiological Parameters Relevant to Dissolution Testing: Behavior of Solid Pharmaceuticals in the GI Tract
• Dissolution Data Analysis with a View to IVIVC
• Analysis and Interpretation of Time Profiles In Vitro and In Vivo
• Pharmacokinetic Study Design with a View to Quality Control
• Dissolution Method Development: An Industrial Perspective
• Design and Qualification of Automated Dissolution Systems

Index

click here to see books of related interest