Formulation and Characterization of Gemifloxacin Mesylate Ophthalmic In-Situ Gel (Research Article)

Author(s): Madhushree Badashetti*, Shankrayya M, Omkarswamy Maradimath, Kavya S U, Megha CM and Sachin Wali

Abstract: Objective: Gemifloxacin Mesylate is an fluoroquinolone antibacterial agent with a broad spectrum of activity. It is a fourth generation fluoroquinolone, has high potency against Gram-positive, Gram-negative bacteria and its bactericidal activity is through inhibition of bacterial topoisomerase II and IV enzymes which are critical in the maintenance, synthesis and replication of DNA. Gemifloxacin mesylate showed good in vivo activity in a model of infective keratitis due to St.aureus ,in comparison to all third generation fluoroquinolones. Method: Gemifloxacin Mesylate in situ gels were formulated using sodium alginate as main polymers and HPMC K4 as co-polymer. Sodium alginate and HPMCK4 were used in different concentration (0.5, 0.1, 1.5 and 2%) whereas HPMCK4 was in (0.6, 0.8, 1 and 1.2 %) respectively and benzalkonium chloride as preservative. All the prepared in-situ gel formulations were evaluated for gelation, pH, drug content, viscosity, in-vitro release study, and the optimized formulation was tested for accelerated stability studies. Results: FT-IR and DSC studies revealed that drug was found to be compatible with formulation excipients. All the formulations were developed using combination of sodium alginate with HPMC K4 and the developed formulations showed satisfactory results for in-vitro gelling capacity, rheology and other physical properties. Conclusion: The in-situ gel is a promising approach for ocular infection. This gel combines the advantage of a solution and its administration convenience with favourable residence time and sustained release.

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