Preparation and Evaluation of Nateglinide-Cyclodextrin Inclusion Complex

Abstract

A physicochemical characterization of nateglinide (NT) - hydroxy propyl s-cyclodextrin (HPsCD) inclusion complex both in solution state and solid state were studied to improve the solubility and dissolution properties of nateglinide. Inclusion complex were prepared by micro wave irradiation and kneading method at 1:1M, 1:2M ratios. The prepared inclusion complex were investigated in solution state by drug content, phase solubility studies and solid state by differential scanning calorimetry (DSC), Fourier transformation-infrared spectroscopy (FTIR), X-ray diffractometry (XRD) and in vitro dissolution studies. Phase solubility studies revealed 1:1M stoichiometry inclusion complex, a true inclusion complex was observed at 1:1 and 1:2M ratios it was confirmed by FTIR, DSC, XRD studies. In vitro dissolution data suggests the dissolution properties of nateglinide was dependent on method and ratio, the inclusion complex of both methods shows superior dissolution properties when compare to corresponding physical mixture and pure nateglinide.