SUSTAINED RELEASE MULTI-PARTICULATES FORMULATION OF STEREO-SELECTIVE MOLECULE OF KETOPROFEN BY FLUID BED PROCESSORAbstract
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.
B. G. Prajapati * and A. Patel
Department of Pharmaceutics, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, Gujarat, India.
22 September 2019
24 April 2020
22 August 2020
01 September 2020