Development of a buccal mucoadhesive film for fast dissolution: mathematical rationale, production and physicochemical characterization

The validity of a mathematical rationale for preparation of a fast-dissolving buccal mucoadhesive was tested. A buccal mucoadhesive biopolymeric formulation has been developed having pullulan as the main component. The formulation was duly evaluated physicochemically, via assays for intrinsic viscosity (resulting in 71.61 cm(3) g(-1)), differential scanning calorimetry analysis (resulting in a Tg = 63 degrees C), thermogravimetric analysis (244-341 degrees C), moisture content determinations (14%, w/w), dissolution timeframe (41.6 s), mucoadhesion force (40 kg/cm(2)), scanning electron microscopy analyses (critical ray under 1.0 mu m), mechanic strength (tensile strength = 58 N/mm(2), deformation = 4.4%). The mucoadhesive formulation exhibited important characteristics for a drug carrier, that is, a 6 cm(2) area, a fast dissolution timeframe, an adequate mucoadhesivity, resistance to both oxygen and water vapor penetration, increased viscosity in solution (ranging from 33.2 cm(3)/g to 71.61 cm(3)/g), easy molding, suitable water solubility and transparency.