Development and evaluation of hyaluronic acid-functionalized, vitamin e-loaded liposome-in-Aloe Vera Gel for oral submucous fibrosis

Abstract

Background: Oral submucous fibrosis (OSMF) is a chronic, progressive, and potentially malignant disorder of the oral mucosa, for which current therapies offer limited efficacy. To develop and characterize a novel composite gel system comprising hyaluronic acid (HA)-functionalized, vitamin E-loaded liposomes incorporated in an aloe vera gel matrix for the management of OSMF. Methods: Vitamin E-loaded liposomes were prepared using the thin film hydration method and surface-functionalized with HA. The liposomes were characterized for size, zeta potential, encapsulation efficiency, morphology, and in vitro release. Antioxidant and anti-inflammatory activities were assessed. The optimized liposomes were incorporated into aloe vera gel, which was evaluated for physicochemical and safety parameters. Results: The HA-functionalized liposomes displayed a mean size of 245.6 nm, a PDI of 0.215, and a zeta potential of -32.4 mV, indicating good stability and uniformity. FTIR confirmed successful encapsulation and HA-coating. In vitro release showed biphasic kinetics with sustained release up to 24 hours. The formulation exhibited potent antioxidant and anti-inflammatory activity. The final gel was stable, mucoadhesive, and non-irritant, with suitable pH, viscosity, and spreadability. Conclusion: The developed HA-functionalized, vitamin E-loaded liposome-in-aloe Vera gel offers a promising, patient-friendly approach for OSMF management, warranting further clinical evaluation.