FORMULATION AND CHARACTERIZATION OF CROSS LINK CHITOSAN MICROSPHERE: APPLICATION AS A MUCOADHESIVE DRUG DELIVERY OF NIFEDIPINE

The purpose of this research was to formulate and systematically evaluate in vitro performance of mucoadhesive microspheres of nifedipine. Cross-linking Nifedipine microspheres containing chitosan were prepared by simple emulsification phase separation technique using glutaraldehyde as a cross-linking agent. A simple lattice design was employed to study the effect of independent variables, volume of cross-linking agent (X1), cross-linking time (X2) and total stirring time (X3) on dependent variables percentage mucoadhesion, drug entrapment efficiency and release of nifedipine. Results of preliminary trials indicate that volume of cross-linking agent, time for cross-linking and total stirring time affected characteristics of microspheres. Microspheres were discrete, spherical, and free flowing. The microspheres exhibited good mucoadhesive property in the in vitro wash-off test and also showed high percentage drug entrapment efficiency. From the statistical evaluation, best batch found showed 60.47 % mucoadhesion after 1 hour, 60 % drug entrapment efficacy and desired drug release profile upto 12 hours by taking 3.2 ml of cross-linking agent, 3 hours of crosslinking time and 3.8 hours of total stirring time. This statistically optimized batch was repeated to validate the results.