Sizing of a vesicle drug formulation by quasi-elastic light scattering and comparison with electron microscopy and ultracentrifugation.

Quasi-elastic light scattering has been used for the sizing of a vesicle formulation. Porcine insulin was encapsulated in a vesicle preparation containing cholesterol, dipalmitoylphosphotidylcholine, digalactosyl digycerides, and dipalmitoylphosphotidylglycerol in a 40:40:15:5 ratio. The measurement requires less than 15 min to obtain mean size and distribution information and can be operated in a quality control environment. Advantages and limitations of quasi-elastic light scattering are described and this method is compared to electron microscopy and ultracentrifugation.