FORMULATION AND EVALUATION OFANTIPLATELET AND ANTI THROMBOTIC IMMEDIATE RELEASE TABLETS

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. All raw materials are weighed according to formula and sifted through the sieve #30. All sifted materials except Cutina HRPH are placed in octagonal blender and blended for 15min. All sifted materials, Cutina HRPH loaded into the octagonal blender and blended for 5min. Samples were taken from at least three places from the blender and the samples were sent to QC for in process analysis. After the QC approval the samples were subjected to tablet making. The blended material was compressed into tablets using rotary die apparatus as per SOP. Tablets were coated with the coating solution of Opadry II pink. 6 tablets were placed in each of 6 dissolution flasks containing 900 ml of pH 2.0 HCl maintained at 37±0.5°C. The apparatus was run for 30 minutes. A suitable volume of sample was withdrawn at regular intervals of time and filtered through 0.45 μm membrane filter. The absorbance of the sample preparations were measured at 249 nm, using pH 2.0 HCl as blank