The objective of present study was to formulate and evaluate clopidogrel bisulphate prefilled syringe for immediate onset of action, reduce time drug wastage and avoid first pass metabolism. I.V solution prepared using propylene glycol (cosolvent) and tween 80 (surfactant) in different concentration. In 32 factorial designs propylene glycol (X1) and tween 80 (X2) were selected as independent variables and pH of the IV solution (Y1) and drug dissolved in 2 ml (Y2) were dependent variables. All formulations were evaluated for clarity, pH, drug dissolved in 2 ml. Optimized formulation was evaluated for one month stability study. The optimization study indicates that pH of the I.V solution and drug dissolved in 2 ml depends on concentration of propylene glycol and tween 80. Regression analysis and analysis of variance were performed for dependent variables. Formulation F6 containing 20% of propylene glycol and 0.2% of tween 80 was optimized. It showed pH 4.61 of the solution and 194.1 mg drug dissolved in 2 ml. The studies indicate that the prefilled syringe of clopidogrel bisulphate can be efficiently formulated by the co solvents and surfactants. The optimized formulation was subjected to stability studies for one month at 40°C temperature with RH 75±5% and showed there was no significant change in Clarity, pH, drug content.
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