Volume :

6

Issue :

1

Abstract :

A novel ionotropic gelation technique was employed to design and develop sustained release Nizatidine microspheres for oral administration. Calcium chloride was selected as cross linking agent and sodium alginate as polymer to control the release profile of the Nizatidine from microspheres. The S1 to S14 formulations were subjected to micromeritic properties, swelling index, % yield, encapsulation efficiency and in vitro drug release. Fourier transform infrared spectroscopy (FTIR) and scanning electron microscope (SEM) were characterized for the prepared microspheres. The optimal formulation used for fabrication of microspheres was dispersion with 2% (w/v) sodium alginate, 10% (w/v) calcium chloride, and the drug Nizatidine content was 450mg based on solid weight in the dispersion. It was indicated that Nizatidine had no interactions with excipient by the FTIR and DSC. The optimized formulation (S6) showed the particle size, bulk density, tapped density, angle of repose, Carr’s index and swelling index of 82.45±0.09 µm, 0.52g/ml, 0.59g/ml, 20˚.54, 7.95%, 97%, respectively. The % yield, %EE and Cumulative % drug release of S6 was found to be 98.3%, 96.3% and 98.54%, respectively. The in vitro drug release was showed the 98.07±0.46% within 12h. The optimized formulation followed the Zero order and Higuchi kinetics indicated the diffusion controlled release mechanism. SEM studies showed the optimized formulation had particles of spherical in shape. The optimized formulation S6 was found to stable. All the results proved that the ionotropic gelation is a novel and promising technique for preparing sustained-release microspheres, and suitable for industrial production due to its successive and controllable step in preparation.