Response surface methodology was applied during process optimization of a parenteral emulsion formulation containing perfluorocarbon (PFC). E-Chip, a computer software program, was used to design and analyze the optimization experiments. The levels of eight process variables of interest were varied: pre-emulsification temperature and mixing time, mixer speed, generator type, rate of PFC addition, homogenization temperature, pressure and number of passes. Dependent variables evaluated included emulsion median diameter, viscosity and percent unemulsified PFC. A predictive model describing the relationship between the dependent and process variables was developed. Median diameter of the emulsion was affected significantly by homogenization temperature and pressure, and marginally by the rate of addition of the PFC. Viscosity was not influenced by any of the process variables. Percent unemulsified PFC was slightly influenced by the number of homogenization passes. The model was then used to set optimum process conditions.
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