Parenteral emulsions stabilized with a mixture of phospholipids and PEG-660-12-hydroxy-stearate: evaluation of accelerated and long-term stability.

Different emulsion formulations were prepared using phospholipids (Lipoid S57) and PEG-660-12-hydroxy-stearate (Solutol HS15) as single emulsifiers or in mixtures. The accelerated stability after autoclaving, freezing and centrifugation was investigated. The long-term stability was also studied at different temperatures (4, 20, and 37 degrees C) for 8 months. Emulsion stabilized with phospholipids displayed a stable behavior after the autoclaving and centrifugation, but it broke down after the freezing process. In mixture with Solutol HS15, however, the emulsion showed appropriate shelf stability at different temperatures for 8 months. A change in the particle size of the emulsion prepared only with Solutol HS15 was observed after centrifugation (slight) and after autoclaving (marked). In contrast to phospholipid emulsion, this emulsion (with only Solutol HS15) was less prone to breaking down after the freezing, as no complete phase separation was observed. The results obtained using an emulsifier mixture revealed that a combination of an anionic surfactant (phospholipids) and non-ionic surfactant (PEG-660-12-hydroxy-stearate) improves the emulsion's stability, compared to the emulsion's stability prepared using only a single emulsifier. However, no direct correlation could be found between the accelerated and the long-term stability data.