SUSTAINED RELEASE MULTI-PARTICULATES FORMULATION OF STEREO-SELECTIVE MOLECULE OF KETOPROFEN BY FLUID BED PROCESSOR

The aim is to prepare sustained release multi-particulates dosage form of Dexketoprofen trometamol, which is the active isomer of ketoprofen. Utilization of active moiety with minimum drug dose and administration frequency sustained-release multi-particulates dosage form is explored. Sustained release pellets of the dexketoprofen trometamol were developed by the fluidized bed technology, in which drugs along with a binder and anti-adherent agents, were loaded onto microcrystalline cellulose inert beads. These drug-loaded pellets were again coated with Kollicoat SR 30D as sustained-release coating polymer, triethyl citrate as plasticizer and talc as an anti-adherent. The formulation was further statistically optimized for agglomerates formation, process efficiency, and drug release profile using central composite design (CCD). Results show that 16.9 to 18.5% w/w sustained release coating with 9.0-14.6% w/w talc and 8.1 to 16.5% w/w triethyl citrate concentration gives desired drug product quality attributes. Sustained-release multi-particulates were successfully developed for dexketoprofen trometamol, which maybe explored to manufacture various dosage forms like capsules, compressed tablets, pellets in sachet etc. for ease of patient compliance.