Influence of Processing and Stabilizer Selection on Microstructure, Stability and Rheology of Emulsion-Based Semisolid Formulations.

Abstract

Background/Objectives: Emulsion-based semisolid formulations are important delivery systems for many applications, including pharmaceuticals, cosmetics and food. The manufacturing process for such formulations typically involves a series of heating, cooling, mixing and emulsification steps. Stabilizing agents are usually included in such formulations, as emulsions are intrinsically unstable and are prone to various destabilization mechanisms. Precise control of each processing parameter and the selection of an appropriate stabilizing agent are essential for delivering products with long-term stability and the desired properties. In this study, the effects of emulsification temperature and the selection of the stabilizing agent on key product attributes were investigated to enable improved design and optimization of both the formulation and manufacturing process. Methods: Model emulsion systems containing propylene glycol (PG) as the dispersed phase and mineral oil as the continuous phase were prepared at different emulsification temperatures to cover both pre-crystallization and post-crystallization regimes. Three stabilizing agents, namely mono-and-diglyceride (MDG), neat monoglyceride (MG) and neat diglyceride (DG), were studied. Their crystallization behavior was first examined to determine crystallization temperatures and crystal morphologies. The resulting emulsion samples were then characterized in terms of their microstructure, physical stability and rheological properties. Results: The emulsions prepared under post-crystallization conditions exhibited better physical stability, higher rheological parameters (crossover stress and viscosity) and a more rigid microstructure compared to those formed under pre-crystallization conditions, regardless of the stabilizer used. Rheological properties were found to corelate well with physical stability. In the pre-crystallization regime, poor stability could partially be mitigated by lowering the emulsification temperature. MG was generally more effective than DG in stabilizing the emulsions and led to higher rheological properties, despite both crystallizing into the same polymorph within the system. This difference in performance was attributed to variations in the crystal morphology and spatial distribution within the emulsion. Notably, the MG-stabilized emulsions also displayed a self-hardening effect during storage. Conclusions: The selection of the appropriate stabilizing agents and processing conditions tailored to the specific system is critical for the successful manufacture of emulsion-based semisolid products with an optimized performance.