A Novel Method to Eliminate Preservatives in Eye Drops.

Abstract

Multiuse eye drops must maintain sterility and typically accomplish this by added preservatives. However, preservatives often cause harmful side effects. A gauze barrier dressing ("BIOGUARD®") recently cleared by the FDA has an immobilized poly diallyldimethylammonium chloride (p-DADMAC) coating and is an effective antimicrobial with minimal compound release into solution. To implement use of this dressing as a replacement for preservatives in multidose eye drop bottles, its ability to maintain sterility without interacting with the active ingredient (AI) of the ophthalmic medication was tested. To determine immobilized p-DADMAC's microbicidal efficacy, it was added to eye drop bottles, then contaminated with Staphylococcus aureus (SA113) bacteria. To assess interference with AI in eye drops, high performance liquid chromatography was used to determine whether the AIs timolol and dorzolamide were affected after exposure to p-DADMAC. To further investigate effects on AI, the microbicidal activity of Vigamox® (moxifoxacin) was assessed after p-DADMAC gauze exposure. S. aureus bacteria were eliminated by p-DADMAC-treated gauze for all samples. The concentrations of both timolol and dorzolamide increased after exposure to p-DADMAC-treated gauze, but spectrometric analysis showed that this did not occur when the p-DADMAC-coated material was presoaked in deionized water. The microbicidial activity of moxifloxacin was unaffected by exposure to p-DADMAC-treated gauze. Due to its lack of effect on eye drop AI and its microbicidal efficacy, p-DADMAC treatment would make an excellent candidate for replacing preservatives in eye drops.