Volume :
2
Issue :
4
Abstract :
The objective of the present study was to develop sustained release tablet of Isosorbide Mononitrate by porous membrane osmotic technology. The drug is mainly indicated for the treatment of Stable and unstable angina pectoris, acute myocardial infarction and heart failure. The tablets were prepared by wet granulation method. The granules were evaluated for angle of repose, bulk density, tapped density, compressibility index and Hausner ratio. The tablets were subjected to thickness, hardness, friability, weight variations, and drug content by assay and in vitro dissolution studies. The drug release from Isosorbide Mononitrate sustained release was carried out in 1.2 N HCl, 4.5 pH acetate buffer and 6.8 pH phosphate buffer for 24hrs. The granules showed satisfactory flow properties, compressibility index and drug content. All the tablet formulations showed acceptable pharmaceutical properties. Formulation variables like type (PVP, PEG 4000 and HPMC) and level of pore former (0-55%, w/w of polymer), percent weight gain were found to affect the drug release from the developed formulations.The optimized formulation showed the highest f2 (f2 = 76.4) value. The drug release from the developed formulation was independent of pH and agitational intensity. The similarity factor F2 was applied between the optimized formulation and the theoretical dissolution profile. The drug release data were plotted using various kinetic equations (Zero order, first order, Higuchi’s kinetics, Korsmeyer and Peppas kinetics and Hixson and Crowell kinetics) to evaluate the drug release mechanism and kinetics. The formulations were found to be stable for after 2 months of accelerated stability studies.