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M. Ozawa, M. Sato, S. Nakaya, A. Kato, H. Hirata, E. Shirasawa; Novel Preservative-Free Drug Container Maintains Content Sterility Despite Bacterial Challenges. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5302.
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© ARVO (1962-2015); The Authors (2016-present)
Application of preservative containing eyedrops can induce ocular irritation and allergies. To reduce this complication, containers are being developed for preservative-free repeated drug delivery. We describe here the results of an assessment of the sterility properties of our novel portable multi-dose preservative-free (NP) container.
NP container and content sterility were examined under the following three conditions: 1) simulated daily use, 2) aspiration of bacterial suspension, and 3) aspiration of rabbit conjunctival fluid. For all experiments, the NP container content was 0.9% saline ((benzalkonium chloride) BAC-free). Its nozzle tip, drops, filter, and contents were also examined for bacterial contamination. Our assessment entailed counting the number of colony forming units (CFU), in culture medium after: 1) Dispensing its contents twice a day for 10 or 20 days 2) Aspirating into the NP container suspensions containing either100-200 CFU of S. aureus, P. aeruginosa, or C. albicans . CFU numbers were determined 0, 3, 6, and 24 h later. 3) Aspirating into the NP container rabbit lacrimal gland fluid obtained by touching the NP container nozzle tip onto the rabbit ocular surface. The results of procedures 1 and 3 were compared with those obtained using a conventional container filled instead with 0.9% saline containing 0.02% BAC.
Under all of the three indicated conditions, the NP container and its contents remained free of any bacterial contamination. At 0 h, a maximum of 75 CFUs were detected but this number declined with time to reach an undetectable level after 24 h. These results were identical to those obtained with usage of a conventional container used to dispense solutions containing 0.02% BAC.
Our novel NP container maintains content sterility as well as that of a conventional one containing 0.02% BAC. Moreover, it is smaller than others of this type. This improvement makes it more portable and safer for convenient ocular surface drug delivery. These attributes are expected to improve patient compliance and therapeutic outcome.
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