Ocular Microbiology and Immunology Group
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2023 OMIG Abstract

A Novel Non Toxic Ophthalmic Preservative

Gregory Schultz¹, Anthony Sawyer², George Rodeheaver³, and Richard A Eiferman<sup>4

1</sup>University of Florida, Gainesville, FL; ²Nevada Naturals, Fountain Hills, AZ; ³University of Virginia, Charlottesville, VA; ⁴University of Louisville, Louisville, KY

Purpose: The FDA requires a preservative to be added to all multi dose eyedrops. Unfortunately, additives such as benzalkonium chloride (BAK) can be toxic or retard wound healing. Monolaurin (ML) and sucrose laurate (SL) are organic esters with innate anti-microbial activity. They are FDA approved and commercially utilized in a variety of food products. We tested this mixture to determine if it would be suitable as a non-toxic ophthalmic preservative.

Methods: Preservative Effectiveness Test (USP 51) was performed using the following test organisms: Staph. aureus, Pseudomonas aeruginosa, Aspergillus braziliensis, Candida albicans and E coli using a standard inoculum of 10 5 organisms. CFU was determined at 14 and 28 days and the log reduction of organisms was calculated. Ocular toxicity testing revealed no sign of ocular irritation from either of the components.

Results: All of the bacterial species had a greater than 4 log reduction of CFU at 14 days and no increase from 14 to 28 days. The yeasts and molds had no increase from the initial count at 14 and 28 days.

Conclusions: Both components passed the antimicrobial Preservative Effectiveness Test. This combination could serve as a non toxic organic substitute for the cationic quaternium preservatives that are presently used in ophthalmic eye drops.

Disclosure: C, E, O, P

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