Development and Characterization of Phytosomal Mucoadhesive Oral Gel of Camellia sinensis Polyphenols
Abstract
Background: Epigallocatechin-3-gallate is a polyphenol obtained from Camellia sinesis. Which acts as an antioxidant and Anti-inflammatory. It exhibits poor water solubility, low lipophilicity (log P ≈ 1.2), and extensive first-pass metabolism, highlighting the need for improved drug delivery methods.
Aim: To formulate a stable phytosomal delivery system for EGCG and incorporate it into a mucoadhesive oral gel suitable for effective oral mucosal and topical applications.
Materials and Methods: Phytosomes were prepared by the solvent-evaporation technique using phosphatidylcholine as the lipid carrier to form stable phyto-complexes. The resulting vesicles were characterised for their morphological and physicochemical properties using Scanning Electron Microscopy (SEM) and particle size analysis. The prepared phytosomal gels (F1–F3) were further evaluated for pH, viscosity, spreadability, and drug content uniformity. In vitro diffusion studies were performed in phosphate buffer (pH 6.8). Kinetic modelling and stability testing at 25 °C ± 2 °C / 60 % ± 5 % RH for 45 days were also conducted.
Results: SEM revealed uniformly shaped spherical vesicles with smooth surfaces. Formulation F8 exhibited the smallest mean particle size of 244 nm, suggesting improved permeation and stability. In vitro diffusion studies demonstrated a sustained-release profile extending over 12 hours, with cumulative drug release ranging from 96.37% to 98.88%. Kinetic modelling of the optimised formulation (F2) indicated diffusion-controlled release consistent with the Higuchi model. Stability testing showed negligible variations in physicochemical parameters and only a slight reduction in drug release (from 98.88% to 94.37%), confirming the formulation’s robustness.
Conclusion: The developed phytosomal mucoadhesive gel offers a promising delivery system for EGCG, capable of improving its therapeutic potential and bioavailability for effective oral mucosal and topical applications.
Keywords: Camellia sinensis, solvent evaporation method, in vitro drug release, phytosomal gel, mucoadhesive system.
Keywords:
Camellia sinensis, solvent evaporation method, in vitro drug releaseDOI
https://doi.org/10.22270/jddt.v15i12.7497References
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Copyright (c) 2025 Sidra Tanveer , Syed Abdul Azeez , Abdul Mannan
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