Ophthalmic drops are subject to microbial contamination during use and storage by repeated opening of bottle when administrating individual doses, touching dropper-tip with infected eye/eyelid or contaminated hands, that why preservatives are added to eye drops packaged in multidose containers to prevent preparation spoilage and minimize hazards of ophthalmic infections ,especially in post-operative patients.
The aim of this study is to evaluate and compare the effectiveness of preservatives in three commercially marketed ophthalmic drops (timolol maleate solution 0.5%, polyvinyl alcohol solution 1.4%, and prednisolone acetate suspension 1%) in Syrian market by compendial antimicrobial effectiveness test which is not yet subject to international harmonization in different pharmacopeias.
The results showed that timolol maleate ophthalmic solution 0.5%, and polyvinyl alcohol ophthalmic solution 1.4% comply with different compendial acceptance criteria in antimicrobial effectiveness test(AET) , while prednisolone acetate ophthalmic suspension 1% didn’t comply with any of compendial acceptance criteria.. There are many reasons can lead to preservative failure like adsorption of preservatives on plastic bottles and/or differences in formulation conditions of eye drops (viscosity- increasing agents, surfactants, incompatibility between product’s pH range and optimal pH range of preservative used).
Bulletin of pharmaceutical Science Assiut.
2022.