Formulation Development and Optimization of Sustained Release Tablets of Gliclazide using Central Composite Design

To treat non-insulin dependent diabetic mellitus (NIDDM), it is intended to optimize and produce gliclazide sustained release tablets. A medicine to meet its objective, it should ideally reach the receptor quickly, at the ideal concentration; stay there for the predetermined amount of time, be rejected from other sites, and be quickly eliminated. The wet granulation process was utilized to make gliclazide tablets with sustained release, including two hydrophilic polymers, guar gum and karaya gum. Talc, magnesium stearate and Aerosil, were added to the formulation as glidants and lubricants, while PVP served as the binding agent. An optimal formulation was found through the application of a central composite design. Statistically significant results were obtained for the main impacts (p<0.05) in the contour and 3D plots. Multiple linear regression analysis was used for constructing polynomial mathematical models for the dependent variables. A batch was prepared at a checkpoint to confirm the identification of the optimal formulation. Because of the improved control over release rate, it was determined from the studies that formulation F14, with polymer levels of guar gum 55.018 mg and karaya gum 28.409 mg, satisfied all maximum requirements for an ideal formulation. The ideal formulation demonstrated cumulative percentage drug release at 20 hours of 82.194 and t₅₀ indicated 10.120 hours, with higher desirability and reduced error. Consequently, FTIR spectra were utilized to verify that gliclazide was compatible with the different polymers that were used to make the gliclazide sustained release tablets. In summary, the formulation of sustained release tablets was facilitated by an optimized strategy, which also helped to understand how formulation processing variables affected that development.