FORMULATION AND EVALUATION OF IN SITU OCULAR GEL OF LEVOFLOXACIN
Total of 8 formulations of in situ gels of Levofloxacin hydrochloride were prepared by pH triggered in situ gelling system using different polymers like sodium alginate as gelling agent, Noveon AA-1 polycarbophil and HPMC E50LV as viscosity enhancing agent and benzalkonium chloride as preservative. All the prepared formulations were clear and the visual appearance was found to be transparent. The pH of the prepared formulations was ranged between 6.50and 7.00. The drug content varied between 96.84 Â± 0.396 and 99.65Â±0.489 % which indicated that the uniform distribution of drug was found in all the prepared formulations. Among all the formulations, the formulations A4 and A8 showed better gelling capacity. The shear rate on the preparation was large during the blinking stage. From the in vitro drug release profile the formulations A4 and A8 was selected as the best formulations and these formulations were used for further studies such as mechanism of drug release, sterility, antimicrobial efficacy, ocular irritation and accelerated stability. Both formulations provided good fit to the Higuchi model. According to this model, the drug release from these gels may be controlled by diffusion through the micro-pores. The selected formulations showed good anti-microbial action against the organisms and ocular irritation studies revealed that the selected formulations were good with non-irritation and there were no ocular damage or abnormal clinical signs. During and at the end of the accelerated stability study, the selected formulations did not undergo any chemical changes/interaction and remained stable during the study period and showed almost similar physical stability and drug content.
Key Words: Levofloxacin hydrochloride, in situ gels, in vitro drug release, Higuchi model, accelerated stability study.
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