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Tablets & Capsules July 2017 13 Determine the ANI's maximum solubility. This entails adding an excess of ANI to each of the SENDS pre- concentrate candidate components, individually or in selected combinations. Once the ANI is added, the com- ponent-ANI mixtures are vortexed to ensure the ANI is randomly distributed within them. These vortexed combi- nations are then agitated for 24 hours at 37°C and allowed to stand for 24 hours at 25°C. Next, the solutions are fil- tered and analyzed for ANI content to determine the maxi- mum ANI solubility in each pre-concentrate candidate. Determine the emulsions' characteristics. After deter- mining their maximum solubility, the selected SENDS pre-concentrate components are plotted on a phase dia- gram. Typically, SENDS components are plotted on two vertices of a simplex and water is plotted on the third ver- tex. Subsequently, binary or pseudo-binary mixtures of the pre-concentrate components are diluted systemati- cally with water, and the phase characteristics of these combinations are observed. Characteristics of interest include clear emulsion formation, emulsion globule size, and phase separation. Emulsion globule size and the sta- bility of the globules are of specific interest because those characteristics can ultimately affect the absorption of the ANI and, therefore, the ANI's bioavailability. Assess the dissolution characteristics. In vitro dissolu- tion testing is required to demonstrate an improvement in the ANI's aqueous solubility in the optimized SENDS formulation compared to the same ANI in a non-SENDS formulation. Additionally, dissolution testing allows observation of the SENDS formulation's phase behavior under stirred sink conditions. Dissolution parameters and media can be adjusted on an individual formula basis as required. Researchers at St. John's University have sug- gested an in vitro dispersion test, which employs USP apparatus 2 (0.01N HCl, 37°C, 50 rpm) [6]. The ANI concentration and the emulsion's globule size are ana- lyzed over time during the test to observe both dissolu- tion and phase behavior of the oil-in-water emulsion. Applications SENDS are suitable for formulating a variety of ANIs, including CoQ10, vitamin E, and quercetin. Figure 2 Effects of CoQ10 on CCl4-induced changes in serum ALT, AST and ALP levels (surrogate biomarkers for hepatic injury) [7] Notes: Data are expressed as mean ± standard deviation. Asterisk denotes P < 0.05 as compared with pure API treated group. Normal Pure PAPI Untreated control S-SNEDDS AST ALT IU/L ALP * * *