title: 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 71.61 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.
authors.affiliation: University of Sorocaba, Laboratory for the Development and Evaluation of Bioactive Substances, Cidade Universitária , Sorocaba/SP , Brazil .
authors.forename: Marta M D C
authors.initials: MM
authors.lastname: Vila
authors.forename: Edgard R
authors.initials: ER
authors.lastname: Tardelli
authors.forename: Marco V
authors.initials: MV
authors.lastname: Chaud
authors.forename: Matthieu
authors.initials: M
authors.lastname: Tubino
authors.forename: Victor M
authors.initials: VM
authors.lastname: Balcão
mesh_terms: D000269:Adhesives / Q000138:chemical synthesis* / Q000493:pharmacokinetics*; D000278:Administration, Buccal; D055598:Chemical Phenomena; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004337:Drug Carriers / Q000138:chemical synthesis* / Q000493:pharmacokinetics*; D008962:Models, Theoretical; D012995:Solubility; D013997:Time Factors; D014783:Viscosity
chemical_list: D000269:Adhesives; D004337:Drug Carriers
keywords: Biopolymers; buccal mucoadhesive carrier; mathematical rationale; natural gums; pullulan