An industrially viable technique for fabrication of docetaxel NLCs for oncotherapy.

The aim of this study is to formulate thermodynamically stable docetaxel loaded nanostructured lipid carriers (DTX-NLCs) for parenteral cancer therapy with improved long term stability and better pharmacokinetic performance. DTX-NLCs were formulated using microemulsion (ME) template technique and characterized for particle size, entrapment efficiency (EE), drug content, and in vitro release kinetics. Further evaluation of NLCs was carried out by IR, DSC, and SEM analysis. The optimized formulation was subjected to stability studies as per ICH guidelines. In vivo pharmacokinetic studies were carried out using SD rats in comparison with a marketed formulation (MF). The particle size of optimized formulation was found to be in the range of 150-180 nm with EE of 68-70% and the SEM images illustrated spherical morphology. In vitro release of the formulation showed a sustained release of the drug from formulation compared to MF. The formulation was found to be stable for a period of 6 months at conditions of 30 °C/ 65%RH, 40 °C/ 75%RH, and 2-8 °C. In vitro cytotoxicity studies revealed better cytotoxic activity of DTX-NLCs than MF against various types of cancer cell lines. In vivo pharmacokinetic studies showed better performance with respect to half-life, volume of distribution, etc. (*p < 0.05, by unpaired t-test) of DTX-NLCs compared to MF.