(607e) Fluid Bed Coating Process for Modified Release Applications

Wurster process (bottom spray fluid bed coating process) is a process of choice for coating of multiparticulates to produce modified or controlled release dosage forms. The principle of the Wurster process and advantages of the Wurster process will be presented.  Formulation and process development of multiparticulates for modified release dosage forms will be discussed.  Scale up considerations for the Wurster process will be presented. Example Quality Overall Summary for Controlled Release Capsules (information from the FDA), section on Manufacturing Process Development, will be used as a guide for discussion with real examples.  Equipment, critical process parameters and ranges and scale up considerations will be discussed.