FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLETS OF ITOPRIDE HYDROCHLORIDE

The objective of this research work was to develop sustained release tablets of Itopride HCl using different hydrophilic polymers like HPMC K4M, HPMC K15M, Carbopol 971P, Metolose 60SH-50, Guar gum, Xanthan gum by direct compression method. Various amounts of combination of polymers in 1:1 ratio were used in the twenty four proposed formulations (F-1 to F-24) for the study of release rate retardant effect at 15 %, 25 % and 35 % of total weight of tablet matrix respectively. Then the tablets were evaluated in terms of their physical parameters (weight variation, hardness, friability and thickness), drug content and In-vitro release studies. All the formulations showed compliance with pharmacopoeial standards. The In-vitro dissolution study were conducted using USP dissolution apparatus type II (paddle method) in 900 ml 0.1 N HCl for first 2 h and remaining 22 h performed in 6.8 pH phosphate buffer at 50 rpm for a total period of 24 h. Based on the dissolution data comparison with innovator, formulation F-8 was found as the best formulation. The drug release of formulation F-8 followed First Order kinetic model and the mechanism was found to be non-Fickian / anomalous according to Korsmeyer-Peppas equation