Optimization of a self-nanoemulsified tablet dosage form of Ubiquinone using response surface methodology: effect of formulation ingredients.

The objectives of the present study were (1) to evaluate the effect of formulation ingredients on the release rate of Ubiquinone from its adsorbing solid compact; and (2) to prepare and evaluate an optimized self-nanoemulsified tablet formulation. A three factor, three-level Box-Behnken design was used for the optimization procedure, with the amounts of copolyvidone (X(1)), maltodextrin (X(2)) and microcrystalline cellulose (X(3)) as the independent variables. The response variable was cumulative percent of Ubiquinone emulsified in 45 min with constraints on weight, flowability index, tensile strength, friability and disintegration time of the dry powdered emulsion and the resultant compact. Based on the experimental design, different Ubiquinone release rates and profiles were obtained. Mathematical equations and response surface plots were used to relate the dependent and independent variables. The regression equation generated for the cumulative percent emulsified in 45 min was Y(6)=64.10-12.32X(1)-4.36X(2)-25.53X(3)+6.99X(1)X(2)+3.97X(1)X(3)+9.70X(2)X(3)-8.98X(1)(2)16.22X(2)(2)+17.10X(3)(2). The optimization model predicted an 85.4% release with X(1), X(2) and X(3) levels of 66.6, 560.1 and 100, respectively. A new formulation was prepared according to these levels. The observed responses were in close agreement with the predicted values of the optimized formulation.