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Abstract

Formulation, development and evaluation of solid dispersions for enhancement of solubility and dissolution rate of clopidogrel bisulfate

Anil Kumar Patel*, Prabhakar Budholiya, C. K. Tyagi

College of Pharmacy, Sri Satya Sai University of Technology & Medical Sciences, Sehore (M.P.)

ABSTRACT

Clopidogrel is a thienopyridine class inhibitor of P2Y12 adenosine 5′-diphosphate (ADP) platelet receptors and used to inhibit blood clots in coronary artery disease, peripheral vascular disease and cerebrovascular disease. Clopidogrel is a pro-drug of carboxyl clopidogrel activated in the liver by cytochrome P450 and CYP2C19 enzyme. The active metabolite has an elimination half-life of about 7-8 h and acts by forming a disulfide bridge with the platelet ADP receptor. In the present study, solid dispersions of Clopidogrel were prepared by physical trituration method to increase its water solubility. Hydrophilic carriers such as polyethylene glycol 4000 were used in the ratio of 1:1, 1:2, 1:4 and 1: (drug to carrier ratio). Percentage assay of different formulation was determined by U.V. Vis Spectroscopy. Further fast dissolving tablets of Clopidogrel were prepared and evaluated. The percentage assay of different formulation was in range of 97.85±0.32 to 99.98±0.21%. The maximum percentage assay (99.98±0.21%) and less disintegration time (99.98±0.21 sec.) were found to be formulation F4 in Fast dissolving tablets. The optimized formulation of batch F4 subjected to further in vitro drug release. The in vitro drug release studies of the enhanced detailing was subjected to integrity of fit test by linear regression analysis as indicated by zero order, first order kinetic Higuchi and peppas release equation, in order to decide the mechanism of drug release. At the point when the regression coefficient values of were looked at, it was watched that 'r' values of first order was most extreme i.e. 0.997 consequently showing drug release from plans was found to take after first order kinetics.

Keywords: Clopidogrel, Solid dispersions, Physical trituration, Solvent evaporation, Kneading method.


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