Solid Lipid Nanoparticles Based Novel Topical Formulation of Terbinafine Hydrochloride

The present research was aimed at developing Solid Lipid Nanoparticle (SLN) based formulation of Terbinafine hydrochloride ((TRB) for topical application. Melt emulsification method was chosen for fabrication of TRB SLN using ultrasound dispersion and Hot High Pressure Homogenization (HPH) techniques. Differential concentration of various surfactants and blend thereof was screened for fabricating SLN dispersion. Routine characterization parameters like particle size, polydispersibility index (P.I.), entrapment efficiency and colloidal stability on standing were analyzed for optimizing formulation variables. Effect of time of sonication on SLN dispersion was optimized. Large scale batches of TRB SLN were taken using HPH. Process parameters like applied homogenization pressure and number of homogenization cycles were optimized thoroughly. The optimized formulation and process parameters were then used for formulating final batches of TRB SLN. Extensive characterization using DSC, XRD, and zeta potential was done. SLN dispersion was incorporated into gel using Carbopol 980 NF. The gel so formed was analyzed for its physicochemical properties. In vitro skin permeation and skin deposition studies on Wistar Rat skin were carried out using Keshary Chien diffusion cell. In vitro occlusivity test was carried out using synthetic membrane. Acute toxicity test was performed using New Zealand Rabbits. In vitro antifungal activity was evaluated against Candida albicans species.