Influence of Various Process Variables and Formulation Excipients on the Engineering of Sertaconazole Solid Lipid Nanoparticles

Abstract

Abstract:The present research work focuses on the study of influence of various ingredients, concentration of ingredients and process parameters on the formulation of Solid lipid nanoparticles (SLN). The sertaconazole loaded solid lipid nanoparticles (SERT-SLN) were prepared by simple, easily reproducible and novel modified solvent emulsification method. Lipid and surfactant solubilizing potential was determined by solubility study. To improve the properties of SLN some excipients were added like cosurfactant TPGS, organic solvent for nanodroplet structure in SLN and charge induction by stearyl amine. Further study was performed to determine the optimum concentration of components such as concentration of surfactant OLML, stearyl amine, TPGS and organic solvent. The process parameters like stirring rate and time, sonication time and cooling temperature also affect the formation of SLN. The formulations were evaluated for average particle size, polydispersity index (PDI) and zeta potential (ZP). The particle size, PDI and ZP of optimized formulation was observed to be 155.1 nm, 0.23 and 9.76 mV respectively. The TEM study confirms the nanometric size particles with particle size < 200 nm. The DSC and XRD study reveals the presence of amorphous nature of SLN. The SERT-SLN formulation was stable at refrigerator and 25 0 C. SERT-SLN showed biphasic release pattern initiated with burst and then sustained release.

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“…Studies on lipid-based nanoparticles have shown that several factors such as surfactant type and its concentration, instrumental conditions, and lipids used in their formulations can have impact on PDI and particle size. 147 …”