Preparation and characterization of nateglinide- β cyclodextrin inclusion complexes

Abstract

The objective of the work is physicochemical characterization of nateglinide (NT)- β-cyclodextrin (CD) binary systems both in solution state and solid state and to improve the dissolution properties of nateglinide via complexation with β-cyclodextrin. Binary systems of NT with β-CD, prepared experimentally by different technique(evaporation and kneading),were investigated in solution state by phase solubility studies and solid state by  differential scanning calorimetry, Fourier transformation-infrared spectroscopy, and in vitro dissolution studies. Phase solubility studies revealed 1:1M stoichiometric solid binary systems. Stability constants (Ks) were calculated were found to be CD dependent. A true inclusion complex of NT with β-CD at 1:1 and 1:2M in solid state was confirmed by DSC. In vitro dissolution data suggests the enhancement of dissolution properties of NT- β-CD binary systems were superior when compared to pure.