Preparation of solid dispersions of ornidazole using mixed hydrotropic solubilization technique and their characterization

Abstract

Aim: The aim of the study was to determine the aqueous solubility of ornidazole using different hydrotropic agents then prepare a solid dispersion of ornidazole by mixed hydrotropic solubilization technique and their characterization. Materials and Methods: Equilibrium solubilities of ornidazole in different aqueous mediums were determined at room temperature. The volumetric flask was shaken on mechanical shaker for 12 h so that equilibrium solubility can be achieved and the solution was allowed to equilibrate undisturbed for 24 h. For the preparation of hydrotropic solid dispersion containing ornidazole and hydrotropic blend, minimum quantity of distilled water at 68°C–70°C contained in a 200 ml beaker was used to dissolve the urea and nicotinamide. Then, ornidazole was added to this beaker (at 35°C–40°C) and a Teflon-coated magnetic bead was dropped in it. Magnetic bead was stirring in a beaker using a magnetic stirrer, maintaining the temperature at 35°C–40°C. The prepared solid dispersions of ornidazole have been characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC), and infrared (IR) studies. Results and Discussion: The hydrotropic blend urea and nicotinamide (1:1 ratio) have been found to increase aqueous solubility of poorly water-soluble drug ornidazole. This mixed hydrotropic blend was used to prepare solid dispersion of ornidazole. DSC thermogram, XRD, and IR spectra showed that there is no interaction between drug and hydrotropic agents. Conclusion: Solid dispersions are containing a blend of urea and nicotinamide as water-soluble hydrotropic carriers show fast release of drug as compared with the pure bulk drug sample and physical mixture. The proposed techniques would be economical, convenient, and safe.