Formulation Optimization and Evaluation of Novel Topical Drug Delivery System for the Effective Management of Psoriasis

Abstract

newline newlineBackground: Psoriasis is a common immune-mediated chronic inflammatory skin newlinedisease characterized by skin thickness, erythema and raised plaques with adherent newlinesilvery scales. Conventional treatments of psoriasis have adverse events that influence newlinepatients adherence. This study investigated the therapeutic potential of Clobetasol (CP). newlineIn recent years, nanostructured lipid carriers (NLCs) emerged as most effective research newlineareas for the delivery of lipophilic drugs In this study, NLCs were developed using newlineClobetasol (CP) as a model drug. newlineMethod: In the present investigation, Quality by Design (QbD) approach was applied for newlinethe development and optimization of nano structured lipid carriers (NLCs) using model newlinedrug Clobetasol (CP). CP-NLCs were formulated by hot homogenization and newlineultrasonication method using compritol 888 ATO, oleic acid and tween-80 as solid lipid, newlineliquid lipid and surfactant respectively. The effect of independent variables (X1-drug: newlinelipid ratio, X2-surfactant concentration and X3- homogenization time) on critical quality newlineattributes of NLCs, i.e. dependent variables (Y1- PS, Y2- PDI and Y3-% EE). Multiple newlinelinear regression analysis and ANOVA were employed to identify and estimate the main newlineeffect, 2FI, quadratic, cubic effect and overlay plot. Transmission electronic microscopy newline(TEM), differential scanning calorimetry (DSC), drug release were characterized. newlineResults and Discussion: The BBD, which employed a 3-level, 3-factor design, newlineinvestigated the impact of lipid ratio, surfactant concentration, and sonication time on newlineparticle size, Polydispersity index, and entrapment efficiency (EE). By analyzing the newlinemodels through ANOVA and diagnostic plots, the optimized formulation composition newlinewas selected using the desirability function. The results indicated that a drug-lipid ratio newlineof 1:7.5 was optimal for all formulations. The spherical-shaped Nanostructured lipid newlinecarriers had a size of 168.3±0.367 and#956;m, a Polydispersity index of 0.248183±0.2847, an EE newlineof 85.4±0.384%, and a desira