Response Surface Methodology as an Approach to Optimization of an Oral Solution

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Abstract
Response surface methodology was used to optimize the cloud point and turbidity of a nonionic surfactant solution that had been used to solubilize a very slightly water soluble drug. A formulation suitable for oral administration with turbidity less than four parts per million and cloud point greater than 60°C was desired. A first-order experiment, specifically, a 24 factorial with four center points, was designed to investigate the effect of four formulation components that had been identified as the most likely to affect turbidity and cloud point. When lack-of-fit tests for the first order linear model indicated that a second-order model would provide a better approximation to the response surface in the experimental region, a central composite design with six center points was run in order to fit second-order linear models. Within the experimental region of the second-order design, a simple first-order linear model with the concentration of one component was adequate to describe the cloud point response function; turbidity was fitted with a three component second-order response equation. Experimental runs were performed to confirm the optimum combination of components predicted by the fitted response functions. Response surface methodology provided an efficient approach to development of a nonionic surfactant solution with turbidity less than 4 ppm and cloud point greater than 60°C while maintaining the concentration of formulation ingredients within ranges suitable for oral administration

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