Preparation and Formulation of Ocusert using Dipping and Solvent Casting Technique
DOI:
https://doi.org/10.32947/ajps.v25i5.1319Keywords:
Ocusert, ocular drug delivery, rate-controlling membrane, Sulfacetamide sodium, solvent casting, dipping methodAbstract
Background: One of the primary challenges in ocular drug delivery is maintaining therapeutic drug concentrations at the target site for a prolonged duration. This is particularly relevant for sulfacetamide sodium, a commonly used antibacterial agent in ophthalmic therapy.
Objective: This study aimed to develop a polymer-based ocular insert (Ocusert) for the extended release of sulfacetamide sodium over a 12-hour period.
Dipping and solvent casting method: Various formulations were developed using the dipping and solvent casting technique, with sodium alginate, polyvinylpyrrolidone K90 (PVP K90), and Eudragit RL PO. The inserts were evaluated for physical and functional properties, including folding endurance, thickness, drug content, swelling index, and in vitro drug release. The optimal formulations were further examined via ex vivo bioadhesion and ex vivo permeation studies using goat corneal tissue.
Results: All formulations demonstrated: pH (6.91–6.99), drug content (4.67 -5.26) mg, drug content percent (93.43%–105.26%), Thickness (0.11-0.53) mm, and weight variation (13.41-81.30) mg. Among them, formulation F14C—containing 1.5% sodium alginate, 7% PVP K90, and 15% Eudragit RL PO—exhibited controlled drug release for up to 12 hours, high folding endurance of over 300 times, swelling index of 242.96%, drug release kinetics of zero order, ex vivo bio-adhesive strength of 0.183 ± 0.016 g, a force of adhesion of 0.083 ± 0.016 N, a tensile strength of 3.116 ± 0.18 (N/mm²), a percent elongation of 358.87% ± 0.164, an SEM shows film thickness was in the range of 552.20 ± 5.30 µm, having a rate-controlling membrane of 616.6 ± 62.12 nm in thickness, and cumulative amount of drug permeated (0.398 mg) in Ex vivo drug permeation study.
Conclusions: The developed ocular insert offers a promising sustained-release platform for sulfacetamide sodium, potentially improving patient compliance and therapeutic outcomes in the management of bacterial ocular infections.
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