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Development of a buccal mucoadhesive film for fast dissolution: mathematical rationale, production and
Marta M D C Vila1, Edgard R Tardelli, Marco V Chaud
1University of Sorocaba, Laboratory for the Development and Evaluation of Bioactive Substances, Cidade Universitária , Sorocaba/SP , Brazil .
Abstract:
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 cm3 g(-1)), differential scanning calorimetry analysis (resulting in a Tg = 63 °C), thermogravimetric analysis (244-341 °C), moisture content determinations (14%, w/w), dissolution timeframe (41.6 s), mucoadhesion force (40 kg/cm2), scanning electron microscopy analyses (critical ray under 1.0 μm), mechanic strength (tensile strength = 58 N/mm2, deformation = 4.4%). The mucoadhesive formulation exhibited important characteristics for a drug carrier, that is, a 6 cm2 area, a fast dissolution timeframe, an adequate mucoadhesivity, resistance to both oxygen and water vapor penetration, increased viscosity in solution (ranging from 33.2 cm3/g to 71.61 cm3/g), easy molding, suitable water solubility and transparency.
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This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...

