Effects of Hydrotropic Phenomenon on Solubility Enhancement of Ebastine; Formulation and Characterization

Abstract

Hydrotropes are the nontoxic small organic molecules that at certain concentrations result in solubility enhancement of poorly water-soluble compounds. In this study various hydrotropes including nicotinamide, sodium acetate and trisodium citrate were used at varying ratios to observe the effect on solubility enhancement of Ebastine. Various combinations of drug-hydrotrope complexes were prepared with each above mentioned hydrotropes using solvent evaporation technique. The resultant residues were subjected to various analytical and characterization techniques for verification of complexation and solubility enhancement. These techniques included Powder X-ray diffraction studies, FTIR and UV spectroscopy. Three different formulations were prepared using various hydrotrop-drug complexes and their stability studies along with in-vitro release were carried out using simulated environment in dissolution apparatus and then later UV spectrophotometric studies were conducted.Standard curve was constructed for UV Spectroscopic analysis and the UV analysis of %age drug release from final suspension dosage form revealed 67.56%, 55.04 % and 66.76 % for the complex containing drug-nicotinamide at ratio of 3:1, drug- sodium acetate at 2:2and drug-trisodium citrate at 2:2 respectively. This release profile clearly indicated the increment in water solubility of the said insoluble drug in the prepared suspension formulated from the drug-hydrotrope complex