Formulation and Evaluation of Bilayer Tablet of Dolutegravir sodium and lamivudine

Abstract

Aim

The aim of current research is to develop a bilayer tablet with dolutegravir sodium and lamivudine.

Experimental Work

In Bilayer tablets, sustained release tablet was prepared by direct compression method and immediate release tablet was prepared by wet granulation method using super-disintegrants such as sodium starch glycolate, crospovidone, croscarmellose sodium and sustained release  polymers such as HPMC K15M, HPMC K100M and Guar gum respectively. The bilayer tablets were evaluated for hardness, thickness, friability, weight change, disintegration time and % drug release.

Result and Discussion

Prepared bilayer tablets were found to have all physiochemical properties in acceptable range. The optimum concentration of HPMC K15M and sodium starch glycolate were required to formulate bilayer tablets. Based on factorial batches formulated, FB7 having 15% HPMC K15M and 8% sodium starch glycolate which shows disintegration time of 2.61±0.01 min and highest %CDR at 45 min and 12 hr of 95.72% and 96.84% release of dolutegravir and lamivudine respectively.

Conclusion

Based on the obtained result,it was inferred that the optimised formulation with the following content was obtained i.e. HPMC K15M and sodium starch glycolate are more desirable to disintegrate and drug release properties. This is why sodium starch glycolate and HPMC K15M are potential polymer and super-disintegrants candidates which can be used to formulate bilayer tablets.