An Experimental Design of SNEDDS Template Loaded with Bovine Serum Albumin and Optimization Using D-Optimal

Abstract

Self Nanoemulsifying Drug Delivery System (SNEDDS) is not only limited to develop Biopharmaceutics Classification System (BCS) class II drugs, but also BCS class III and IV. Protein is classified into BCS class III because of its good solubility and its poor permeability. It needs suitable composition to load hydrophilic substance into lipophilic carrier such as SNEDDS. The objective of the study was to optimize SNEDDS template for Bovine Serum Albumin (BSA) protein using D-optimal mixture design. In this study, BSA was used and loaded into a SNEDDS template. Mixture of D-optimal design was used for optimization. The optimized template contained minimum amount of surfactant and maximum amount of oil that shows enhanced transmittance and emulsification rate. Sixteen formulas consisting of oil phase (X1, Mygliol 812), surfactant (X2, Chremophore EL 40), and co-surfactant (X3, Span 20) were evaluated for transmittance and emulsification time. The optimum SNEDDS template was then loaded with 1mg/ml BSA. Characterization results of the optimum template showed 55,4 nm of the size, -0,9 mV of zeta potential, spheric morphology, 34,24±0,53 second of emulsifying time, 94,20±0,82% of transmittance, and 87±0,4 0 C of cloud point. The template was also resistant to 100, 200 and 1000 times dilution using water as medium, Simulated Gastric Fluid (SGF), and Simulated Intestinal Fluid (SIF).