Formulation of buccal microemulsions containing fluocinolone acetonide

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Objectives: The purpose of the present work is to formulate buccal microemulsions (MEs) of fluocinolone acetonide (FA). Methods: Solubilities of FA in different oils were determined for screening of MEs components. In order to determine the concentration ranges of components in MEs, pseudo-ternary phase diagrams were constructed using water titration method. Only the area covered by the transparent region was termed as the ME existence region. The suitable ratio was selected to prepare 0.1% FA ME preparations. Results: Due to high solubility of FA in clove oil (25.22 mg/ml) and peppermint oil (9.5 mg/ml), these two oils were selected to develop ME systems. The pseudo-ternary phase diagram was composed of clove oil or peppermint oil, Tween 80, PEG 400 and water. The phase diagram containing surfactant mixture (Smix) (2:1) provided a larger ME region than the one containing Smix (1:1). Turbid 0.1% FA MEs were obtained from the blank ME systems containing Smix (1:1) and precipitation of FA was observed in 24 hours. However, clear 0.1 % FA MEs without precipitation were received when prepared in blank MEs of 3.5% clove oil, 31.5% Smix (2:1), 65 % water and 15% peppermint oil, 35% Smix (2:1), 50% water. Conclusion: Pseudo-ternary phase diagrams containing clove oil or peppermint oil were constructed in order to formulate buccal microemulsions of FA. The use of Smix (2:1) ratio of Tween80 to PEG400 provided a larger ME region in phase diagrams compared with Smix (1:1) ratio. In addition, the blank MEs containing Smix (2:1) dissolved FA better than the one containing Smix (1:1) ratio.

Keywords: microemulsions; fluocinolone acetonide; oral lichen planus