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Solubility and Dissolution Properties of Gliclazide

Gliclazide is a second generation sulfonylurea drug, characterized by poor solubility and, hence, by a low dissolution rate in water. This property causes inter-individual variations of its bioavailability. The major drawback in the therapeutic application and efficacy of gliclazide as oral dosage forms is its very low aqueous solubility because of its hydrophobic nature. Statistical experimental design is the methodology of how to conduct and plan experiments in order to extract the maximum amount of information in the fewest number of runs. With the rapidly rising cost of conducting experiments, it is essential that optimization be achieved with as few experiments as possible. This is one important reason why statistical experimental design is needed. Most experimentation today is done by changing levels of one factor (variable) at a time in a non-systematic way in order to try and find the optimum conditions of a complex system. It is not a good strategy because of its low efficacy, non-rationality and expense. A key concept often employed in optimization methodology is the response surface graphic. The response surface graphic is a geometrical representation of the response and the factor levels similar to a contour graphic. The formulation or a region in which its response has optimal characteristics based on the experimenter‘s specifications can be chosen in this way. Results of this study indicate the low aqueous solubility and low dissolution rate of gliclazide. A factorial design study was used to investigate the results, and the polynomial equations were constructed for further investigations.