Formulation and In-Vitro Evaluation of Mucoadhesive Ocular Inserts for Enhanced Retention of Sulfacetamide Sodium
Keywords:
Mucoadhesive ocular inserts, Sulfacetamide Sodium, sustained drug release, bioavailability, ocular retention, in-vitro evaluation, hydrophilic polymers, bacterial conjunctivitis.Abstract
The present study focuses on the formulation and in-vitro evaluation of mucoadhesive ocular inserts containing Sulfacetamide Sodium, a broad-spectrum antibiotic widely used for treating bacterial conjunctivitis and other ocular infections. Conventional eye drops suffer from poor bioavailability and rapid precorneal elimination, requiring frequent administration. To overcome these limitations, five formulations (F1–F5) were prepared using hydrophilic polymers—hydroxypropyl methylcellulose (HPMC), sodium alginate, and chitosan—via solvent casting technique. The inserts were evaluated for physicochemical properties, drug content, swelling index, tensile strength, in-vitro drug release, ex-vivo mucoadhesion, and sterility. Among all, formulation F2 demonstrated optimal performance with a thickness of 0.224 mm, surface pH of 7.02, and drug content of 99.3%. It exhibited sustained drug release over 12 hours (94.2%), following Higuchi diffusion kinetics. F2 also showed the highest mucoadhesive strength (15.3 g) and longest ocular retention (94 min). Histopathological evaluation confirmed no tissue damage, and all formulations passed sterility tests. The results confirm that mucoadhesive ocular inserts are a safe, effective, and patient-compliant alternative to conventional eye drops for ocular drug delivery, offering prolonged drug retention and improved therapeutic efficacy.
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