Influence of β-cyclodextrin on Cefixime Stability in Liquid Suspension Dosage Form

Abstract

Cefixime is a third generation of cefalosporin antibiotic which is easily to hydrolize in water and usually prepared in the form of tablet and dry suspension dosage form. Formation of active ingredient in the form of inclusion complex was one of the methods which can be employed to increase its stability to hydrolytic degradation.The purpose of this study was to evaluate the stability of cefixime-β-cyclodextrin inclusion complex in liquid suspension dosage form. The Inclusion complex of cefixime with β-cyclodextrin were prepared by utilizing of kneading and freeze drying method with weight ratio of 1:1, 1:2 and 1:3. The Inclusion complex formation were confirmed by infrared spectroscopy (FTIR), powder X-ray difractometer (PXRD) and Scanning Electron Microscopy (SEM). The formulation of cefixime liquid suspensions were prepared in the citrate buffer pH of 3.5 for pure cefixime, physical mixture of cefixime with β-cyclodextrin and inclusion complex from each method. Further studies werestability tested for each formulae of cefixime in liquid suspension in 40°C and 75% RH and the remaining concentration of cefixime were determined by HPLC method. The best ratio for formation of inclusion complex was showed by ratio cefixime: β cyclodextrin 1:2. Stability test of cefixime liquid suspension showed that the stability of cefixime in inclusion complex made by freeze drying method decreased the stability instead of increased cefixime stability. Meanwhile there was no differences between stability of pure cefixime, its physical mixture with β-cyclodextrin and inclusion complex made by kneading. Thus, the preparation of cefixime-β-cyclodextrin inclusin complex was not effective in achieving the enchangement of cefixime stability.