Formulasi dan Karakterisasi SelfNanoemulsifying Drug Delivery System (SNEDDS) Esomeprazol Magnesium Trihidrat

Abstract

The Self-Nanoemulsifying Drug Delivery System (SNEDDS) is developed as an effort to increase the solubility of lipophilic drugs such as esomeprazole magnesium trihydrate, so as to increase their dissolution rate and bioavailability. This study aims to make a SNEDDS formulation of esomeprazole magnesium trihydrate that meets pharmaceutical characteristics. The SNEDDS formulation consists of virgin coconut oil as oil, tween 80 as a surfactant and polyethylene glycol 400 as a co-surfactant. Evaluation of the optimum SNEDDS formula includes measurements of percent transmittance, dispersibility, stability (heating-cooling cycle, centrifugation, freeze-thaw cycle), robustness to dilution, refractive index, particle size, polydispersity index, zeta potential, drug content and dissolution rate. The best formula for SNEDDS esomeprazole magnesium trihydrate (F11) at a ratio of oil : Smix (surfactant : co-surfactant) 1:6 with a ratio of Smix (surfactant : co-surfactant) 2:1 because it is able to form nanoemulsions spontaneously, no phase separation occurred in the thermodynamic stability test, stable in the robustness to dilution test, fulfilling the requirements for percent of transmittance (99.346 ± 0.019 %), time dispersibility (16.44 ± 0.955 seconds), refractive index (1.346 ± 0.0002), globule size (78.03 ± 0.249 nm), polydispersity index (0.467 ± 0.005), zeta potential (-34.57 ± 1.837 mV) and drug content (100.337 ± 0.725%). The results of the in vitro dissolution rate test at 30 minutes showed that the SNEDDS preparation of esomeprazole magnesium trihydrate was higher than pure esomeprazole magnesium trihydrate, namely 87.10 ± 2.104% and 19.45 ± 0.50%, respectively. It was concluded that esomeprazole magnesium trihydrate can be formulated in the dosage form SNEDDS with good pharmaceutical characteristics