Design of Experiments (DOE).

In the present study compared and evaluated the three granulation process for controlled release antidiabetic drug of Gliclazide. The effect of three different polymers on the in-vitro dissolution profiles of Gliclazide controlled release tablet was studied. Later combinations of polymers were used and the tablets were prepared by using wet, dry and MADG (Moisture Activated Dry Granulation) process. The study was carried out using full factorial designs of experiments. The release rate of 5 to 6 mg%/ hour was targeted and the effect of the polymers on drug release over 24 hours was evaluated. The DOE experiments have shown that when the combination of polymer is used, the total polymer concentration should be in a narrow range of 32.4% w/w to 37.5% w/w in order to achieve the target dissolution profile for Gliclazide. The effect of three granulation process on the tablet properties and drug release were studied. Wet granulation and MADG process were compared. Finally MADG process is showing better results when compared with other process.