Antibacterial Activity of Beyond Use Date 0.3% Ofloxacin Eye Drops against Pseudomonas aeruginosa
Abstract
Pseudomonas aeruginosa is a Gram-negative bacterium and a major cause of healthcare-associated ocular infections. The beyond-use date (BUD) of ophthalmic preparations is intended to ensure drug safety and efficacy. This study aimed to analyze the effect of the BUD of 0.3% ofloxacin eye drops on the growth of P. aeruginosa. This in vitro experimental study used a post-test only control group design. Samples were obtained by purposive sampling using P. aeruginosa colonies, with five samples in each time group. Antibacterial activity was evaluated by measuring inhibition zone diameters and analyzed using the Friedman test followed by the Wilcoxon test. The mean inhibition zone diameters at day 0, day 7, day 14, day 21, and day 28 were 37.4 mm, 34.2 mm, 31.6 mm, 30.0 mm, and 29.4 mm, respectively (p < 0.001). Statistically significant differences were observed among the BUD groups from day 0 to day 28 (p < 0.05); however, no significant difference was found between day 21 and day 28 (p > 0.05). The findings indicate that extended storage time may compromise the stability of the active pharmaceutical ingredient, thereby contributing to a measurable decline in antibacterial efficacy.
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