Formulation and characterization of IV injectable fat emulsion

Abstract

Introduction: Intravenous nutrition is one of the most important medical achievements of the twentieth century, as it rescues many patients with malnutrition and focuses on the medical attention to nutrition. Intralipid, an injectable oil in water emulsion (O/W) a high volume product. Objective: The purpose of this study is to provide a method for preparing a formulation for a suitable lipid injection drug. Materials and Methods: In this study, 6types of lipid formulation were used, each of which was studied at 3temperatures. Formulations included glycerin, miglyol, egg lecitin, water, sodium hydroxide and soylecitin. The emulsion was prepared for each of the 6 types of formulation. The initial emulsion was placed in a sonicator after 48 hours to reach the equilibrium. After reaching the equilibrium, the pH was adjusted to7.4 by adding sodium hydroxide. The emulsion was then homogenized to obtain a stable emulsion. The droplet size of the prepared emulsion was then measured, and if it was in normal range, the rest of the steps continued. The micro-emulsion was then divided into 3parts and each was placed at oven temperatures, refrigerator and room temperature. Results: Only the micro-emulsions that was kept at the refrigerator temperature during the study was stable. In the case of L5,L6 formulations, the emulsion of which used SoyLecitin as emulsifier, were remained stable for up to 2years after preparation, and also had a droplet size in normal range (which is equal to 846 nm and 640). In the case of surface tension, according to the results, the surface tension of L5 and L6 formulations was lower than others and were respectively 22.8 and 24.33 DYNES/cm. Conclusion: Formulations prepared with Soylecitin, can maintain their stability for a period of 2 years at a refrigerated temperature.