The present study explores the pharmaceutical potential of a natural organic matter (fulvic acid) for sustained\r\nrelease, acid buffering capacity and mucoadhesion in vaginal drug delivery. The antifungal drug, Itraconazole,\r\nwas first converted into inclusion complexes with fulvic acid (1:1 & 1:2 molar ratio) and then characterized by\r\nDifferential Scanning Calorimetry (DSC), X-Ray Diffraction (XRD), Fourier Transform Infrared\r\nSpectroscopy (FT IR) and Mass Spectroscopy. Results were also authenticated by conformational analysis.\r\nSolubility analysis of complexes yielded different thermodynamic parameters and explained the driving force\r\nfor solubilisation when the pH was varied in an acidic range. MTT assays were also performed to assess the\r\npotential in vitro cell toxicity of the complexes in comparison to the neat drug. The complexes were then\r\nformulated into tablets and optimized for hardness, mucoadhesion and release profiles. The optimized tablets\r\npresented with satisfactory mucoadhesion, acid buffering and spreading ability. Moreover, the antifungal\r\nactivity of the formulation was also increased due to improved aqueous solubility of the drug despite the\r\nlarger size of the complex. The study also indicated the potential use of fulvic acid as a functional excipient in\r\nthe preparation of a vaginal drug delivery system (VDDS).
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