Development, evaluation and clinical studies of Acitretin loaded nanostructured lipid carriers for topical treatment of psoriasis

Abstract

The objective of the present study was to formulate and characterize Acitretin loaded Nanostructured Lipid Carriers (ActNLCs), to understand in vitro drug release and clinically evaluate the role of the developed gel in the topical treatment of psoriasis. ActNLCs were prepared by solvent diffusion technique using 3(2) full factorial design. The mean diameter and surface morphology of ActNLC was evaluated. ActNLCs were lyophilized and crystallinity of NLC was characterized by Differential Scanning Calorimtery (DSC) and powder X-Ray Diffraction (XRD). The NLCs were incorporated in 1% w/w Carbopol 934 P gel base and in vitro skin deposition studies in Human Cadaver Skin and double-blind clinical studies in psoriatic patients were conducted. The optimized ActNLCs were spherical in shape, with average particle size of 223(±8.92)nm, zeta potential of -26.4 (±0.86) mV and EE of 63.0(±1.54)%. DSC and XRD data confirmed the formation of NLCs. Significantly higher deposition of Acitretin was found in human cadaver skin from ActNLC gel (81.38 ±1.23%) as compared to Act plain gel (47.28±1.02%). Clinical studies demonstrated significant improvement in therapeutic response and reduction in local side effects with ActNLCs loaded gel indicated its effectiveness in the topical treatment of Psoriasis.