Abstract

PREPARATION AND EVALUATION OF SUSTAINED RELEASE PELLETS OF SAXAGLIPTIN BY EXTRUSION-SPHERONIZATION

Balasaheb B. Nishane*, Kailas N. Tarkase, Madhurani K. Tarkase and Mahesh D. Dokhe

Abstract

The present search engrossed on the preparation and evaluation of sustained released pellets of Saxagliptin using a different grade of polymers like Eudragit L and Eudragit RLPO as a sustained released polymer. Pellets were prepared by using Extrusion spheronization method in which water was used as a solvent and microcrystalline cellulose which acts as the spheronization aid. The pellets were prepared and evaluated for the pre-formulation studies like Bulk density, Tapped density, Compressibility index, and Hausner‟s ratio. Evaluation parameters were found within a standard range which indicated that pellets were prepared by Extrusion-spheronization processes having a satisfactory result for further studies. Friability of pellets was found to be within standard range.DSC and FT-IR studies confirmed the compatibility of the drug with the polymer in the drugloaded polymer. The prepared formulation was spherical in nature confirmed by SEM photography and sphericity factor. Drug content was in the range of 99.25%. Stability studies were carried out for a period of 90 days 40 0c 75 RH hence pellets was found to be stable in nature.

Keywords: Saxagliptin, Eudragit L, Eudragit RLPO, microcrystalline cellulose, Extrusion-spheronization method, In-Vitro study.