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Sanjay Kumar Yadav*, Arti Gupta, Amrit Patel, Ravinder Bhati
IIMT College of Pharmacy, Greater Noida, Uttar Pradesh, India
*Address for Corresponding Author
Prof. Sanjay Kumar Yadav
IIMT College of Pharmacy, Greater Noida, Uttar Pradesh, India
Abstract
Objective: Isosorbide Mononitrate is mainly indicated for the treatment of stable and unstable angina pectoris, acute myocardial infarction and heart failure. The objective of the present study was to develop sustained release tablet of Isosorbide Mononitrate by porous membrane osmotic technology. Material and methods: 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 1.2N HCl, 4.5 pH acetate buffer and 6.8 pH phosphate buffer for 24hrs. Results and conclusion: The granules showed satisfactory flow properties, compressibility index and drug content. All the tablets 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 agitation intensity. The similarity factor f2 was applied between the optimized formulation and the theoretical dissolution profile.
Keywords: Coating, extended release, Isosorbide mononitrate, osmotic pressure, osmotic pump, stability