Preparation, statistical optimization, in-vitro evaluation and characterization of solid lipid nanoparticles of an anti-retroviral drug Nevirapine

Nevirapine-loaded solid lipid Nanoparticles (SLNs) were manufactured using lipid and emulsifying agent by hot homogenization method. The goal of research was to formulating a SLN system to target the HIV reservoir which is mostly found in the lymphatic system and to conquer the obstacle of drug itself. Also, nearly 50% of antiviral drugs fall within BCS class 2, which have low solubility. 44% antiviral drugs belongs to BCS class 3 have inadequate permeability and 6% belongs to class 4 with inadequate solubility and inadequate permeability. Depending on the NVP solubility and stable formulation, stearic acid as a lipid and poloxamer 188 and tween 80 as an emulsifying agent were chosen and SLNs were manufactured with the help of hot homogenization method. Optimization of independent variables such as lipid concentration, emulsifying agent concentration and no. homogenization cycle was carried. The effect of independent variables on the dependent variables i.e. particle size and entrapment efficiency was studied. Optimized formulation which was lyophilized (L-SLN) and this L-SLN additionally characterized using DSC, SEM and XRD analysis. Also, in-vitro drug release of optimized batch studied in 0.04 M Sodium phosphate buffer pH 6.8 containing 2% SLS, demonstrated 41.83% release at the end of 24^th hr. Absence of low intensity in XRD indicated the presence of amorphous SLNs. SEM showed the morphology of SLNs. No prominent changes observed in the accelerated stability studies.