Design and Characterization of Fast Dissolving Solid Dispersion Tablets of Gliclazide

Background

Diabetic mellitus is the oldest and most commonly occurring disease known as a life-threatening disease in all age groups from the past 3000 years ago, which is taking away the liveliness from the persons and shortening their lives based on the prevalence.

Materials and Methods

The present research work is to enhance the solubility and dissolution of gliclazide by preparing stable solid dispersions with Polaxomer-188, Polaxomer-407, Cremophor-RH-40, Solutol-HS-15 as solubilizing agents to formulating gliclazide fast-dissolving tablets. Solid dispersions were prepared by physical mixture, solvent evaporation and melting technique with the drug to carrier ratio of 1:1, 1:2, and 1:3 w/w respectively. Prepared formulations were evaluated by FTIR, DSC, XRD, SEM and in vitro dissolution performance.

Results and Discussion

Results showed that the solubility has increased 43.29 folds with enhancement in solubility of prepared solid dispersion formulations when compared to gliclazide drug. FTIR studies showed the retainment of a few individual characteristics group peaks in the drug structure. XRD pattern and DSC thermograms showed a significant change in crystallinity to amorphous of gliclazide. From the study, poloxamer-407 was indicated as the suitable carrier and melting technique as a suitable method for enhancement of solubility and dissolution of gliclazide. Optimized solid dispersion was further prepared into fast-dissolving tablets and was evaluated for pre and post-compression studies.

Conclusion

From the obtained data, it was concluded that Polaxomer-407 can be used as the solubilizing agent with low concentration in the preparation of fast-dissolving tablets.