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Formulation and Evaluation of Israpidine Extended Release Matrix Tablets
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The purpose of this study was to formulate and evaluate an efficient Isradipine extended release matrix tablets designed to provide 24 hours drug release profile using varying proportion of hydrophilic polymers viz; Lactose monohydrate and HEC as matrix-forming material. Prepared matrix tablets showed satisfactory physicochemical properties where drug content was 98.24% to 101.06 %, thickness was 3.33 mm to 3.55 mm, hardness was 7.52±0.171 to 8.94±0.285 kg/cm2 , friability was less than 1% and % weight variation was within the standard pharmacopoeial limits of ±7.5% of the weight. Mathematical analysis of the release kinetics of the optimized formulation (F15) was best fitted in zero order kinetics (R2 = 0.9743). The dissolution profiles of formulation F15 and innovator product in multi media were compared in pH 4.5 acetate buffer, pH 6.8 phosphate buffer, 0.1N HCl respectively. The stability data reveals that the F15 showed a negligible change in drug content after storage in various conditions for two months according to ICH guidelines.
Keywords
Isradipine, Matrix Tablets, Lactose Monohydrate, HEC, Extended Release.
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