Assessment of release of trimetazidine hydrochloride from orally disintegrating tablets (odts) prepared using different disintegrants

The purpose of the study was to assess impact of four disintegrants (starch, microcrystalline cellulose, crospovidone and croscarmellose sodium) on release of trimetazidine hydrochloride from orally disintegrating tablets (ODTs). Tablets weighting 100 mg and containing 20 mg of trimetazidine were prepared with direct compression method using Erweka AR 400 tablet press machine. The following parameters were analyzed for obtained tablets: thickness, weight, hardness, friability, disintegration time, wetting time as well as water absorption ratio. The dissolution studies were performed using paddle apparatus (Erweka 600DT) and 900 ml of dissolution medium (artificial saliva pH 5.8, NaCl phosphate-buffered pH 6.8 and 0.1MHCl pH 1.2). SEM micrographs were made to analyze the surface of the tablets. Data were analyzed with ANOVA or t-student test. The dissolution profiles of trimetazidine to all media were compared by calculation the similarity and difference factors (f1, f2). The thickness and weight of the tablets prepared from each formulation were uniform. The shortest disintegration time (22.7 s) was observed for tablets with crospovidone while the longest ñ for formulation containing starch (78.5 s). The release of trimetazidine from formulations with crospovidone and croscarmellose sodium is better characterized by first order kinetics. In case of formulation with crospovidone the release of trimetazidine to artificial saliva reached almost 100% during 2 minutes.