Development and Evaluation of Polymer-bound Glibenclamide Oral Thin Film

Abstract

Glibenclamide (GLB) is a second-generation sulfonylurea oral hypoglycemic agent used in the treatment of non- insulin dependent diabetes mellitus. The use of this drug is limited due to its poor dissolution and pharmacokinetic profile. In order to nullify these drawbacks, GLB oral thin films were prepared and evaluated to study the influence of preparatory conditions on the physicochemical properties by using Scanning Electron Microscopy (SEM), Fourier Transform Infra-red Spectroscopy (FTIR) and Differential Scanning Calorimetric (DSC). The surface pH of the GLB thin film was found to be in the range of 6.50 ± 0.10 and it is non-irritant to mucosal lining of the oral cavity. The results of the SEM analysis showed uniform surface morphology with homogenous distribution of GLB pure drug in PVP matrix. The in vitro drug release profile at pH 5.0 and 7.5 revealed sustained release patterns for a period of 8 h. The GLB oral thin film showed an enhanced in vivo insulin release profiles as compared to pure GLB drug. Thus, the results of the present study revealed that, the prepared GLB oral thin film can be used as alternative strategy to deliver glibenclamide for diabetes mellitus as it showed a significant role in increasing in vitro dissolution and in vivo insulin release profiles