Bioequivalence Study of Indomethacin from Loaded Spermaceti Wax Microspheres on Healthy Albino Sheep

The present study aims at probing in vitro release and bioequivalence of Indomethacin (IM) loaded spermaceti wax microspheres with Microcid®SR. The microspheres of spermaceti wax have been prepared by meltable emulsified cooling solidification method and the conditions such as drug/wax ratio; pH and amount solvent; and rotational speed and time are optimized. The drug loaded spermaceti microspheres were characterized by SEM, DSC, FTIR and stability studies. The bioavailability of optimized formulation has been established by randomized cross over study on 10 fasting healthy albino sheep on two separate occasions. Plasma IM concentrations and pharmacokinetics parameters were statistically analyzed. Spermaceti microspheres have shown controlled release and it can be concluded that prepared formulation and Microcid®SR are bioequivalent in terms of rate and absorption.