The aim of the present study was to formulate, evaluate and optimize fast dissolving tablets of glimepiride. Glimepiride is one of the third generation sulfonylurea used for treatment of type 2 diabetes. Poor aqueous solubility and slow dissolution rate of the glimepiride lead to irreproducible clinical response or therapeutic failure in some cases due to sub therapeutic plasma drug levels. Consequently, the rationale of this study was to improve the solubility, dissolution rate and biological performance of the drug. Solid dispersion of glimepiride with polyethylene glycol 6000 was prepared by fusion method. Further solid dispersions were formulated as fast dissolving tablets by direct compression technique using superdisintegrants like sodium starch glycolate (SSG) and croscarmellose sodium (CCS) in different concentrations. SDs was evaluated for FTIR, DSC, XRD and SEM, in-vitro dissolution profiles. Among different formulations of SDs, SD prepared by fusion method containing drug to polyethylene glycol 6000 in the ratio of 1:2 by fusion method gives best dissolution profile and among tablet formulations, containing 30% cross carmellose sodium (CCS) gives faster disintegration and dissolution profiles compared with other formulations. Results showed that polyethylene glycol 6000 is a promising carrier for enhancing the solubility of glimepiride. Prepared tablets were evaluated for angle of repose, weight variation, hardness, %friability, wetting time, drug content, disintegration and in-vitro dissolution studies. The results of stability studies revealed no change in physical appearance, drug content and in-vitro dissolution profile, thus indicating that formulations was stable. FTIR, DSC, XRD and SEM studies revealed that there was no significant interaction between drug and polymer in the formulations. Among all the formulations, Formulation GP6 prepared with croscarmellose sodium (CCS 30%) was found to be optimized as compared with other formulations.
Loading....