Development and Optimization of Eudragit® L100 Film for Ocular Delivery of Prednisolone for Dry Eye

Abstract

Background: One of the more prevalent ocular conditions, dry eye causes between 30 to 40 million individuals in the United States on its own and is a serious human medical issue. Ocular films of prednisolone were developed using a variety of polymeric methods to improve drug accumulation; these films showed benefits such as easier delivery and longer interaction times.

Objective: The major purpose of the current research focuses on the creation and optimization of ocular films of prednisolone for the management of dry eye to maximize the therapeutic impact by prolonged interaction at the corneal surface.

Method: The current study sought to formulate ocular Films of Prednisolone for treating of dry eye utilizing solvent casting method. The concentration of Polyvinyl pyrrolidone K-30 and Glycerine used as polymer and plasticizer, respectively, in the ocular films were optimized using the central composite design (CCD). Thickness, pH and drug release parameters were adopted as dependent responses. Ocular films were assessed for different physicochemical parameters like film thickness, folding endurance, surface pH, uniformity of weight, drug content, swelling index, moisture adsorption, moisture loss, in-vitro release study, kinetic study, stability study and test of ocular irritation on rabbit eye.

Results: The optimized ocular film (P2) with thickness 0.506 mm and pH 6.8 showed appropriate physicochemical characteristics for ocular delivery. The optimized formulation released 90.75% of the encapsulated drug during 12 h. Release followed Higuchi kinetics and revealed transport mechanism was non-fickain. Tests for stability were conducted on this improved formulation. The ocular film passed the sterility test, and the physicochemical characteristics did not significantly alter between the 0th and 60th day. Thus, it was discovered that the formulation was stable. The films did not cause ocular toxicity or irritation, according to the results of the eye irritancy test.

Conclusion: Our research leads us to the conclusion that optimized prednisolone ocular film (P2) may help alleviate dry eye by increasing residence duration, prolonging drug release, and requiring less frequent administration.

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Materials

Prednisolone was collected from Central Drug House (P) Ltd., Delhi, India. The following excipients were purchased from Central Drug House (P) Ltd., Delhi, India: Eudragit® L 100, Polyvinyl Pyrrolidone K-30(PVP K-30) and Glycerine. Analytical grade substances and solvents were utilized in the formulation

Vindhya Pal, Sushma Verma, Prashant Verma et al. Development and Optimization of Eudragit® L100 Film for Ocular Delivery of Prednisolone for Dry Eye, 11 August 2025, PREPRINT (Version 1) available at Research Square, https://doi.org/10.21203/rs.3.rs-7283794/v1

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