June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Microbial Ingress Risk Evaluation of Novelia Multi-Dose Package for PG/HPG Nano-Emulsion Lubricant Eye Drops
Author Affiliations & Notes
  • Cynthia L McAnally
    Alcon Laboratories Inc, Fort Worth, Texas, United States
  • Monica Crary
    Alcon Laboratories Inc, Fort Worth, Texas, United States
  • Paul Shannon
    Alcon Laboratories Inc, Fort Worth, Texas, United States
  • Footnotes
    Commercial Relationships   Cynthia McAnally Alcon Laboratories, Code E (Employment); Monica Crary Alcon Laboratories, Code E (Employment); Paul Shannon Alcon Laboratories, Code E (Employment)
  • Footnotes
    Support  All authors are current employees of Alcon Laboratories. No grants were accepted or used to support this study/abstract.
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 1997 – A0327. doi:
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    • Get Citation

      Cynthia L McAnally, Monica Crary, Paul Shannon; Microbial Ingress Risk Evaluation of Novelia Multi-Dose Package for PG/HPG Nano-Emulsion Lubricant Eye Drops. Invest. Ophthalmol. Vis. Sci. 2022;63(7):1997 – A0327.

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      © ARVO (1962-2015); The Authors (2016-present)

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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 products containing 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 PG/HPG nano-emulsion (propylene glycol/hydroxypropyl guar preservative-free lubricant eye drop) presented in the NOVELIA® Multi-Dose package over 30 and 90-day use periods.

Methods : Two methods were evaluated per Note for Guidance on In-Use Stability Testing of Human Medicinal Products (CPMP/QWP/2934/99) to simulate consumer use. First, after four days of dispensing, the tip and air intake were submerged in a high level (106 CFU/mL) suspension of Brevendamonas diminuta and the tip actuated to simulate routine use of the product followed by a gross contamination event similar to falling into a heavily contaminated liquid. Following the 30-day simulation, the internal contents of replicate samples were evaluated for sterility per USP<71>. Second, after 90 days of dispensing to simulate routine use of the product, the internal contents of replicate samples at T0 and 6-month stability conditions of 25°/40%RH and 30°/75%RH were evaluated per USP<61>. A passing result of no microbial recovery indicates the packaging system prevented microbial ingress into the bottle while a failing result of microbial recovery indicates ingress into the packaging system.

Results : For all microbial challenge simulations, a passing USP<71> sterility result was obtained following the 30-day use simulations of the NOVELIA package. For all 90-day routine use simulations, no microbial recovery was observed over 6 months of monitored stability.

Conclusions : PG/HPG nano-emulsion when presented in the NOVELIA package with the PureFlowTM 200 nozzle remains contaminate-free for up to 90 days. Users who suffer from dry eye disease now have the option of PG/HPG nano-emulsion preservative-free lubricant eye drops in a unique multi-dose package.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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