Abstract
Purpose :
Microbial keratitis is a risk for all users of topical ophthalmic solutions due to microbial proliferation within the formulation upon accidental contamination of the product. Historically, preservatives added to the formulation are included to inhibit the growth of microbes introduced from repeated use. Preservative-free products are viable alternatives for individuals who are sensitive, or have reservations about using traditional preservatives. To mitigate microbial growth without the use of preservatives, a multi-dose packaging system must present a physical barrier to contamination throughout the use period. This study evaluates the potential of microbial ingress into Systane Ultra presented in the NOVELIA® Multi-Dose Preservative Free package over a 30-day use period.
Methods :
Two challenge methods were evaluated for 30 days per Note for Guidance on In-Use Stability Testing of Human Medicinal Products (CPMP/QWP/2934/99) to simulate consumer use. First, the tip was challenged daily with low levels (102 CFU) of Brevundimonas diminuta (ATCC 19146) after actuation to simulate the tip routinely contacting a contaminated surface. Second, after four days of dispensing, the tip was submerged in a high level (106 CFU/mL) susp. of B. diminuta and actuated to simulate routine use of the product followed by a gross contamination event similar to falling into a heavily contaminated liquid.
Following each 30-day simulation, the internal contents of replicate samples were evaluated for sterility per USP<71>. A passing result indicates the packaging system was able to prevent microbial ingress into the bottle, while a failing result indicates ingress into the packaging system.
Results :
For all simulations, a passing USP<71> sterility result was obtained following the 30-day use simulations and microbial challenges of the NOVELIA package.
Conclusions :
Systane Ultra Preservative Free when presented in the NOVELIA package with the PureFlowTM 200 nozzle remains contaminate-free over a 30-day use period, even when subjected to extreme cases of accidental contamination. Users who suffer from dry eye disease now have the option of Systane Ultra Preservative Free in a unique multi-dose package.
This is a 2021 ARVO Annual Meeting abstract.