Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Sujan Khadka, Anisha Pandey, Rambriksh Sah, Subeksha Yadav, Anil Bhusal*, Sandeep Pandit, Sajan Maharjan

Abstract

The main aim of this study is to develop a fast-dissolving tablet containing both amlodipine besylate and atorvastatin calcium using superdisintegrants—Croscarmellose Sodium (CCS), and Sodium Starch Glycolate (SSG) at varying concentrations. Thirteen formulations were designed by central composite design (CCD) using Minitab software, in which the concentration of SSG was varied from 0.757% to 9.242% w/w and that of CCS from 0.171% to 5.828% w/w. The preparation process involves geometric mixing of the APIs along with the excipients, followed by direct compression. The UV-visible spectrophotometric method used for the estimation of both the drugs was validated for linearity, limit of detection, limit of quantitation, accuracy and precision. The powder blends were evaluated for pre-compression parameters such as angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The formulated tablets were investigated for thickness, appearance, organoleptic properties, weight variation, hardness, friability, wetting time, dispersion test, disintegration time, drug content and in vitro dissolution. FT-IR studies were carried out to determine possible drug–excipient interactions. IR spectra of pure drug Amlodipine and Atorvastatin and its mixture with excipients were analyzed and interpreted. Specturm obtained from FT-IR concluded no interaction occurred between drug and excipients. With addition of super disintegrating agents like Croscarmellose Sodium (CCS), Sodium Starch Glycolate (SSG) Improved disintegration and dissolution parameters were obtained. Drug content on the optimized formulation for Amlodipine and Atorvastatin was found to be 96.14% and 100.15% and dissolution study for Amlodipine and Atorvastatin was found to be 95.17% and 95.55%. The disintegration time for the optimized formulation was 10 seconds. Fast dissolving tablet of Amlodipine Besylate and Atorvastatin Calcium using super disintegrants was successfully prepared and evaluated. Hence, fast dissolving tablet of Amlodipine and Atorvastatin can be used commercially for the better patient compliance which saves time as well as low cost.

Keywords: Fast Dissolving Tablets, Amlodipine besylate, Atorvastatin Calcium, Superdisintegrants, Direct compression method.