Development and Evaluation of a Microemulsion-Based Gel System for Improved Delivery of Therapeutic Agents in the Management of Oral Submucous Fibrosis

Abstract

Background: Oral Submucous Fibrosis (OSMF) is a long-term, progressive condition affecting the oral mucosa, marked by fibrotic changes, restricted mouth opening (trismus), and a persistent burning sensation. Existing treatment options are often inadequate, mainly due to issues like poor drug solubility, instability, and low bioavailability. Lycopene and Coenzyme Q10 possess significant antioxidant and antifibrotic activities, making them promising therapeutic agents; however, their clinical effectiveness is limited by formulation-related challenges. Aim: The objective of the study was to develope, optimize, and evaluate a microemulsion-based gel incorporating lycopene and coenzyme Q10. A systematic Quality by Design (QbD) framework, supported by a Design of Experiments (DoE) approach, was employed to ensure an efficient and targeted formulation for the management of Oral Submucous Fibrosis (OSMF).