FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS ENALAPRIL MALEATE USING DIFFERENT SUPERDISINTEGRANTS
N. G. Raghavendra Rao*, K. Shruthi and C. Kistayya
Enalapril maleate is a prodrug that is rapidly metabolized by liver esterases to enalaprilat following oral administration. Enalapril maleate lowers the blood pressure by antagonizing the effect of the RAAS. (Renin angiotensin system). It stimulates the secretion of aldosterone from the adrenal cortex. In the present study work has been made to prepare, formulate and characterize fast dissolving tablets of enalapril maleate. The tablets of enalapril maleate were formulated by direct compression technique using superdisintegrant like Crospovidone, Sodium starch glycolate and Croscarmellose in different ratios. The prepared were evaluated for various pharmaceutical characteristics viz. hardness, % friability, weight variation, drug content, in-vitro dissolution profiles. Results showed that the direct compression technique by using superdisintegrants successfully used for enhancing the solubility of Enalapril Maleate. The prepared tablets were characterized using FTIR and finally the prepared tablets were evaluated for various pharmaceutical characteristics such as hardness, % friability, weight variation, drug content all the results were within the IP Limit. The in-vitro disintegration time is measured by the time taken to undergo uniform disintegration. Rapid disintegration within several minutes was observed in all the formulations. The in-vitro disintegration time of Enalapril Maleate fast dissolving tablets prepared by direct compression, was found to be in the range of 46 to 121 sec in using superdisintegrants method fulfilling the official requirements. The in-vitro disintegration time of Enalapril Maleate prepared by direct compression method F6 formulation containing CCS 6% shows around 46 sec. Based on the in-vitro disintegration time, formulation F5 and F6 were found to be promising and showed a disintegration time of 46 and 61.26 sec respectively. CCS 6% and 4% containing tablets rapidly exhibit high capillary activity and pronounced hydration with a little tendency to gel formation and disintegrate the tablet rapidly. The in-vitro drug release showed 99.9% within 20min. The results of stability studies revealed no change in physical appearance, and after three month the tablets were again analyzed for the hardness, friability and disintegration time. No change was observed in the hardness, friability and in-vitro dispersion time of tablets prepared by direct compression technique. Thus Results showed that the direct compression technique by using superdisintegrants successfully used for enhancing the solubility of Enalapril maleate
Keywords: Enalapril Maleate, Mannitol, Crospovidone, Croscarmellose, Sodium starch glycolate, direct compression method.
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