The primary objective of the work was to develop a self nano emulsifying drug delivery system of dolutegravir HCL. Self-nanoemulsifying drug delivery system is a lipid based formulation which consists of isotropic mixtures of oils, surfactants and co-surfactants. It can conveniently develop the emulsion on gentle agitation and offers a considerable surface area for interaction between the SNEDDS formulation and the aqueous gastrointestinal fluid. This may lead to enhanced bioavailability of hydrophobic agents. The Liquid SNEDDS was prepared and after that solidified by aerosil 200. For 10 gm of liquid SNEDDS; 5 gm of Aerosil 200 was used and after that product is dried by spray drying method. And 12 gm of product is remaining after the process. The drug-excipients interaction studies were carried out using FTIR and DSC. The interaction studies were carried out to check physical and chemical stability of Dolutegravir with other excipients. FTIR spectra showed the characteristic peaks of drug (i.e. for C-H stretch, N-C stretch) appear in the spectra of physical mixtures at the same wave number indicating no modification or interaction between drug and the polymers. The liquid SNEDDS formulation C1 showed good thermodynamic stability without any precipitation and having globule size 536.6 nm and zeta potential -29.9. Based on thermodynamic stability, precipitation studies, self-emulsification studies, globule size and zeta potential liquid SNEDDS of formulation batch C1 was selected as optimized formulation. Liquid SNEDDS and solid SNEDDS was prepared for Dolutegravir. SEM, IR, and DSC results confirmed that drug was present in an amorphous state in solid SNEDDS. In-vitro drug release and drug content of optimized formulation was found to be 98.64 and 99.35% respectively. F3 batch of capsule formulation shows better drug release than marketed formulation.
Dolutegravir HCL, Self nano emulsifying drug delivery system, Solubility, Lipid
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