Design of Eudragit E100 Films Incorporating Lipoic Acid as a Permeability-Enhancing Platform for Prednisolone Delivery in the Treatment of Ophthalmic Diseases.

Prednisolone (PRED), a widely used corticosteroid for the treatment of ocular inflammation, has limited bioavailability due to its poor water solubility. In this study, Eudragit E100-based films incorporating polyethylene glycol 400 (PEG) and α-lipoic acid (ALA) as plasticizers were developed and characterized to improve the ocular delivery and corneal permeability of PRED. ALA, which is also known for its antioxidant and therapeutic properties in ocular surface disorders, plays a dual role by enhancing both the mechanical properties and drug delivery performance of the films. The E100:PEG:ALA:PRED (1:0.3:0.2:0.2) formulation exhibited flexibility, mucoadhesion, and controlled-release behavior. Furthermore, cell viability and wound-healing assays were performed to evaluate the biocompatibility of the films. In addition, ex vivo permeability studies using porcine corneas revealed significantly enhanced PRED penetration compared with a commercial eye drop formulation (Sophipren Ofteno® 1%) and demonstrated that the films induced minimal corneal irritation. Based on these findings, Eudragit E100 films containing ALA, PEG, and PRED may represent a promising alternative to conventional ophthalmic suspensions, as they provide sustained drug release while potentially simplifying dosing regimens.