Background: Low aqueous solubility is a major problem faced with new drug molecules.
The purpose of this research was to provide a fast dissolving oral dosage form of Gliclazide (GLZ) using
the concept of mixed hydrotropy. The recent patents on Adenosine (US20140107059A1), Growth
hormone releasing factor peptide (EP0984788A1) and Paclitaxel (WO2002030466A2) helped in selecting
Methods: Solubility of GLZ was determined individually in sodium salicylate, nicotinamide, lactose,
sodium acetate, urea, trisodium citrate and sodium benzoate. Highest solubility was obtained in 40%
sodium benzoate solution. In order to decrease the individual hydrotrope amount, mixed hydrotropic
agents were used.
Results: Highest solubility was obtained in 25:15 ratio of sodium salicylate and sodium benzoate. This
optimized combination was utilized in the preparation of solid dispersions which were evaluated for Xray
diffractometry, Differential Scanning Calorimetry (DSC) and Fourier-transform infrared to show no
drug-hydrotropes interaction. This solid dispersion was compressed to form fast dissolving tablets. Dissolution
studies of prepared tablets were done using USP Type II apparatus.
Conclusion: The batch G3 tablets showed 86% cumulative drug release within 14min with in vitro
dispersion time of 33sec. It was concluded that the enhancement in solubility of GLZ is a clear indication
of the potential of mixed hydrotropy which is a novel, safe and cost-effective technique to be employed
for other poorly water-soluble drugs having low bioavailability.