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

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 71.61cm3g1), differential scanning calorimetry analysis (resulting in a Tg=63°C), thermogravimetric analysis (244341°C), moisture content determinations (14%, w/w), dissolution timeframe (41.6s), mucoadhesion force (40kg/cm2), scanning electron microscopy analyses (critical ray under 1.0m), mechanic strength (tensile strength=58N/mm2, deformation=4.4%). The mucoadhesive formulation exhibited important characteristics for a drug carrier, that is, a 6cm2 area, a fast dissolution timeframe, an adequate mucoadhesivity, resistance to both oxygen and water vapor penetration, increased viscosity in solution (ranging from 33.2cm3/g to 71.61cm3/g), easy molding, suitable water solubility and transparency.