Design Of Experiment Approach for Optimization and Characterization of Lycopene and Coenzyme Q10 Microemulsion for Treatment of Oral Submucosa Fibrosis

Abstract

Background: Oral Submucous Fibrosis (OSMF) is a chronic, progressive disorder of the oral mucosa characterized by fibrosis, trismus, and burning sensation. Current therapies offer limited benefits due to poor solubility, stability, and bioavailability of drugs. Lycopene and Coenzyme Q10, with strong antioxidant and anti-fibrotic properties, have therapeutic potential but are limited by these formulation challenges. Aim: The study aimed to design, optimize, and characterize a microemulsion of Lycopene and Coenzyme Q10 using a Quality by Design (QbD)-based Design of Experiments (DoE) approach for effective management of OSMF. Result: A microemulsion was formulated using olive oil, Tween 80, and glycerol, optimized through a Box–Behnken Design. The optimized formulation showed a particle size of 52 nm, zeta potential of –31.9 mV, and a PDI of 0.366, indicating nanoscale uniformity and stability. Entrapment efficiency was 74.5% for Lycopene and 97.5% for Coenzyme Q10. In-vitro release studies demonstrated biphasic, sustained drug release, ensuring both immediate and prolonged antioxidant effects.