Abstract: The purpose of this research was to develop Dolutegravir sustained release 200mg matrix tablets. Dolutegravir is a second-generation HIV integrase strand transfer inhibitor (INSTI) and the most recent antiretroviral drug approved for the treatment of HIV-1 infection. Six formulations of Dolutegravir 200mg were formulated by direct compression technique using different hydrophilic polymer grades such as PEO, Xanthan Gum and HPMCK15M were used as rate controlling polymers in different concentrations and other ingredients are Magnesium stearate, Talc, Sodium Lauryl Sulphate, before the formulation the granules are evaluated by pre-compression studies. The obtained tablets were evaluated with different post-compression parameters like hardness, friability, thickness, weight variation, drug content, in vitro dissolution studies. The formulation F4 was selected as an optimized formulation because it gives best results in terms of in vitro drug release in a sustained release manner and best fitted to first order model with R2 value of 0.999. Short time stability studies indicate no appreciable changes in drug content and in vitro drug release of optimized formulation of F4.
Keywords: Formulation, Evaluation, Sustained release, Pharmacokinetic studies