FORMULATION, EVALUATION AND OPTIMIZATION OF FAST DISINTEGRATING CLOPIDOGREL TABLETS

*Aswathi V., Sujith S. Nair and Sreena K.

ABSTRACT

The main objective of the research work is to formulate the Clopidogrel fast disintegrating tablets. Clopidogrel, an antiplatelet drug used to control heart attack, hypertension by inhibiting platelet activation and aggregation. Fast disintegrating tablets disintegrate or dissolve quickly in the saliva without the need of water. The fast dissolving tablets of Clopidogrel were prepared employing different concentrations of sodium starch glycolate, crospovidone and croscarmellose sodium in different combinations as a Superdisintegrant by direct compression technique. FTIR studies for drug & excipients revealed that there is no incompatibility/ interaction between drug and excipients. The developed formulation were then charecterised for their physical appearance, bulk density, tapped density, carr’s index, hausner’s ratio, angle of repose, weight variation, hardness, friability, drug content, thickness, in vitro disintegration, in vitro dissolution and stability studies. The fast disintegrating tablets prepared using sodium starch glycolate, crospovidone and croscarmellose sodium as superdisintegrant showed better result and hence selected as optimized formulation. The optimized formulation was subjected to stability studies under 3 different conditions. From the stability studies after 90 days, it was found that there was no significant change in appearance drug content, friability, hardness, in vitro disintegration and in vitro dissolution. The in vitro drug release from the tablets showed significantly improved drug dissolution with an increase in concentration of the superdisintegrants. Hence these fast dissolving tablet dosage form could be a potential formulation which could improve the bioavailability reducing the dosing frequency, improved patient compliance.

Keywords: Clopidogrel, fast disintegration tablets, direct compression, superdisintegrants.