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

Drug Deliv. 2014 Nov;21(7):530-9. doi: 10.3109/10717544.2013.851301. Epub 2013 Nov 5.

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.

Keywords: Biopolymers; buccal mucoadhesive carrier; mathematical rationale; natural gums; pullulan.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adhesives / chemical synthesis*
  • Adhesives / pharmacokinetics*
  • Administration, Buccal
  • Chemical Phenomena
  • Chemistry, Pharmaceutical / methods*
  • Drug Carriers / chemical synthesis*
  • Drug Carriers / pharmacokinetics*
  • Models, Theoretical*
  • Solubility
  • Time Factors
  • Viscosity

Substances

  • Adhesives
  • Drug Carriers