Formulation and Evaluation of Fast-disintegrating Tablets of Flurbiprofen and Metoclopramide

Abstract

The present study was aimed to formulate and evaluate fast-disintegrating tablets (FDTs) having Flurbiprofen (FP) and Metoclopramide HCl (MHCl) in combination. Direct compression was used to formulate FDTs of FP and MHCl as a combination regimen in six formulations. FDTs are defined as solid oral dosage form that disintegrates rapidly within seconds when placed in the oral cavity. FDT-1, FDT-2, FDT-3, FDT-4, FDT-5, and FDT-6 were formulated using crospovidone, croscarmellose sodium, and sodium starch glycolate as superdisintegrants each in two formulations. Several pre-compression tests (angle of repose, bulk density, tapped density, Hausner’s ratio, and compressibility index), post-compression evaluation (weight variation, friability, hardness, disintegration time, wetting time, assay, in vitro dissolution study, release kinetics study, statistical analysis, and stability study), and drug compatibility study were done for all six formulations. Pre-compression evaluation showed good flow properties of powder blend. Drug compatibility study showed no interactions between active drugs and excipients. Disintegration and wetting time of all the formulations were in seconds indicating immediate release of drug. Optimized formulation (FDT-6) containing sodium starch glycolate in 15 mg gave 100% release in 15 min for MHCl and in 20 min for FP. Optimized formulation was found stable after being placed at accelerated stability conditions for 6 months. Release kinetics study showed that all formulations followed Korsmeyer-Peppas model indicating drug release from modified release dosage form. Statistical analysis revealed no significant difference statistically (p > 0.05) between drug release rate of all prepared formulations. FDTs improved the release rate that assured that this tactic may be beneficial to increase the dissolution rate of FP and MHCl in order to increase patient compliance.