CDP - Comparative Dissolution Profiles
Basic Concept of Comparative Dissolution Profiles (CDP) Introduction CDP is among the common quality control tools in pharmaceutical industries. To prove effect of manufacturing process related changes on formulation in the preapproval or post-approval space, most regulatory agencies recommend dissolution profile comparison be conducted with a specified number of reference (prechange) and test (postchange) drug product lots. Various regulatory guidelines are available on this subject such as EMA, TGA, USFDA etc. This post tries to summarise some basic concepts of CDP refering regulatory guidelines. What is CDP? Dissolution profiles of reference and test products are performed with a validated dissolution method using the medium described in the regulatory application as well as two additional media, for example: · 0.1 N HCl or simulated gastric fluid without enzymes · pH 4.5 acetate buffer · pH 6.8 phosphate buffer or simulated intestinal fl