Design and quality control of fast dissolving atorvastatine calcium and amlodipine besylate tablets
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In the present investigation, a blend of superdisinegrants and wetting agent consist of sodium starch glycolate, crospovidone Xl-10, starch 1500 and aerosol were utilized to develop fast dissolving tablets of atorvastatine calcium and amlodipine besylate with a vision to improve patient compliance and fast onset of action by direct compression method. The simple physical blends of superdisinegrants and wetting agent were characterized for angle of repose, bulk density, tapped density, Carr's compressibility index, Hausner's ratio and compatibility studies by FTIR spectroscopy. Fast dissolving tablets of atorvastatine calcium and amlodipine besylate were prepared using the physical blends of superdisinegrants and wetting agent. Prepared tablets were evaluated for hardness, friability, disintegration time, dispersion time, wetting time, drug content and drug release. Formulation F10 prepared by adding 2% w/w aerosol and superdisinegrants sodium starch glycolate, crospovidone XL-10, starch 1500 in ratio of 1: 1: 1 showed minimum dispersion time of 48±6.12 s, disintegration time of 24±0.6 s and higher amount of amlodipine besylate release of 97.68±1.59% at the end of 5 min and atorvastatine calcium release of 103.32 ±0.86% at the end of 10 min. Formulation F-10 was developed as best formulation based on disintegration properties and drug release characteristics in pH 6.8 phosphate buffer compared with the tablets obtained from conventional formulation F-1of as well as with marketed preparation. This study revealed that the combination of superdisintegrants and wetting agent have excellent flow properties, low disintegration and dissolution time, thus fast onset of action for the treatment of hypertension and hyperlipidemia.
Direct compression, Superdisintegrants, Wetting agent, Atorvastatine Calcium and Amlodipine Besylate.