Department of Pharmaceutical Quality Assurance, Mahatma Gandhi Vidyamandir's Pharmacy College, Nashik
Dolutegravir is an HIV-1 antiviral agent used to control HIV/AIDS. In the present study, Dolutegravir inclusion complexes have been subjected to improvement in solubility and dissolution rate performance by being formulated as immediate release tablets, in which ?- CD were used as polymers. Inclusion complexes of dolutegravir were prepared with different ratios of dolutegravir and ?-CD (1:0.5, 1:1, and 1:2) by the kneading method. The pre-compression and post-evaluation parameters were studied, and the results were shown. All the results were within acceptable IP limits. Finally, by comparing all the dissolution profiles of the inclusion complex, Formulation F2 containing Dolutegravir + ?- CD (1:2) showed better results by the kneading method at the end of 45 min with maximum drug release; hence, it is selected as the best formulation. From the obtained optimized inclusion complex formulation, the Immediate release tablets were prepared by using different concentrations of various solubility enhancers and super disintegrants. The in-vitro drug releases of the formulated Dolutegravir tablets were performed using a 6.8 pH Phosphate buffer as a dissolution medium. The optimized F2 formulation contained Sodium starch glycolate (SSG) (6% w/w) as a super disintegrant, and it showed 99.75% drug release at 45 min. Characterization in the solid-state was done by analytical methods such as UV-visible and FT-IR studies.
Renuka Sagane, Kiran B. Erande, Solubility Enhancement, Formulation and Evaluation of Dolutegravir, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 206-213. https://doi.org/10.5281/zenodo.10443939
10.5281/zenodo.10443939
