FORMULATION AND EVALUATION OF ORODISPERSIBLE DOSAGE FORMS INCORPORATING DRUG NANOPARTICLES CONTAINING CLOPIDOGREL BISULPHATE

Clopidogrel bisulphate (CB) is the rate of dissolution often controls a sparingly soluble orally administered drug and the rate of absorption. Reports suggest that the drug has poor water solubility which may be challenging for developing liquid dosage forms of Clopidogrel bisulphate. Hence in the present study, we sought to develop orodispersible nanoparticles to enhance the solubility by an anti-solvent evaporation technique using stabilizers as PVPK-30, Poloxamer-188, PVA, L-arginine and tween-80. We found that the particle size was ranging between 154.7 nm to 844.2 nm and % Drug entrapment efficiency was 42.4% to 97.1% respectively. Among all the formulations, F3 stabilized with L-arginine and PVA has been found to show 92.62 ± 0.81% drug release at the end of 10 min in both 0.1N HCl and phosphate buffer (pH6.8). Through SEM studies we found that the particles were small with no aggregation. Further, the particles (F3) were compressed into tablets F3(c) through direct compression method and characterized based on some selected parameters in comparison with the marketed tablet. We have also observed a satisfactory clopidogrel excipient compatibility through FT-IR investigation. DSC and XRD results have illustrated that the crystallinity of drug was lost in lyophilized powder and tablet converted to an amorphous form. Hence, we concluded that the optimized formulation of Clopidogrel bisulphate could improve the rate of absorption controlled by the rate of dissolution.