Development, characterization, and in vitro assessment of multilayer mucoadhesive system containing dexamethasone sodium phosphate

Abstract

The main goal of this work is the design of a mucoadhesive system, based on three layers for the unidirectional release of dexamethasone sodium phosphate (DEX-F) for possible use in the oral mucosal cavity. The different layers were created by the electrospinning process, using polyvinylpyrrolidone (PVP) and poly(ε-caprolactone) (PCL)as polymeric base and polycarbophil (NOVEON^® AA-1, PCF) as adhesion enhancer. The system contains a drug-release layer, an adhesive layer and a backing layer. The nanofibers matrices were characterized morphologically by scanning electron microscopy (SEM), Fourier-transform infrared spectroscopy (FTIR), thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC); in vitro drug content, degradation time and ex vivo mucoadhesive properties studies were performed. SEM images showed the formation of fibers with a variable diameter and porosity between the layers. Thermal studies TGA and DSC indicated an excellent thermal stability for materials. In vitro studies show a drug content release of 79.86% ±13.5% of the loaded drug in a 4 h release period. Mucoadhesive evaluation exhibit excellent characteristics for a mucosal adhesion. The produced electrospun mucoadhesive patch exhibited an excellent stability, thermal properties, mucoadhesive properties, and the appropriate amount of drug released, promising features for successful DEX-F delivery in a mucoadhesive system for oromucosal surface.

Graphical Abstract

Keywords:

• Electrospinning
• mucoadhesive
• multilayer
• nanofiber
• poly(vinyl-pyrrolidone)
• poly(ε-caprolactone)

Acknowledgments

Authors would like to thank the Centro de Nanociencias y Nanotecnología (CNyN) de la Universidad Nacional Autónoma de México, Ensenada, Baja California, México for kindly provide research facilities. This Project was supported by 19th and 20th Internal Call for Research Projects UABC and the Program for Strengthening of Academic Bodies SEP/PRODES 2018.

Disclosure statement

No potential conflict of interest was reported by the author(s).