Measurements of size distribution and density of a pharmaceutical fat emulsion, using field-programmed sedimentation field-flow fractionation (SdFFF).

PURPOSE

The main goal was to establish that sedimentation field-flow fractionation (SdFFF), operated with power based field programming, is effective in the characterization of a commercial emulsion, Medialipide. This emulsion is used clinically for total parenteral nutrition and it is consisted of a mixture of long-chain triglycerides (LCT, soybean oil) with medium-chain triglycerides (MCT) emulsified by phospholipids.

METHODS

Different field programming methods were used in the analysis to establish the limits of applicability of the technique.

RESULTS

Identical size distribution profiles were obtained under various conditions of the analysis. The density of the droplets was determined by collecting fractions from the SdFFF eluting bands, and analyzing them by photon correlation spectroscopy. The value of density of the oil droplets was changed in the SdFFF data, until best agreement with the PCS values was achieved. The value of density corresponding to the best agreement was considered as the oil density, and it was closed to the weighted average value between soybean and MCT oils.

CONCLUSIONS

Field programming extends the capabilities of sedimentation field-flow fractionation in handling and characterizing complex and delicate samples as Medialipide.