Abstract

Sedimentation field-flow fractionation (SdFFF) operated with power-based field programming, was shown to be effective in the characterization of submicron investigational pharmaceutical emulsions. Field programming, in which the decrease of field strength with time gradually decreases the retention of sample components, extends the capabilities of sedimentation field flow fractionation in handling polydisperse and multicomponent samples. The emulsions were made of medium chain triglycerides (MCT) oil in water emulsified by phospholipids. They were analysed by different rates of field decay and different flow rates. Identical size distribution profiles were obtained under all circumstances, using the appropriate stop-flow times. Fractions were collected from the SdFFF eluting bands, and diameters were analysed by photon correlation spectroscopy, showing good agreement with values given by the FFF instrument at high flow rates and low rates of field decay. Accurate and highly reproducible size distribution profiles were obtained under various conditions. The detector response was shown to consist mostly of light scattering and was linear with concentration.

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