Characterization of metoprolol succinate coated with Surelease(TM) polymer and fluid bed monitoring using NIR.

摘要

Current manufacturing of metoprolol succinate drug products does not have adequate online process control of moisture content which normally affects coating efficiency and drug release. Proper monitoring of this factor during the fluidized bed coating process will provide valuable information for the manufacturing of dosage forms (Flake). Important consideration of Process Analytical Technology (PAT) is also necessary to characterize the effects of process parameters: spray rate, inlet temperature and curing temperature on the dissolution of metoprolol succinate (Schaefer). The aim of this study is to use PAT in the characterization of important factors affecting coating efficiency and drug release of metoprolol succinate. Moisture content and drug concentration were monitored during the fluidized bed coating process using Near Infra-red Spectroscopy. Effects of process parameters, such as spray rate, inlet temperature and curing temperature (based on experimental design) were studied on dissolution of metoprolol succinate from beads coated with Surelease(TM) film.