EVALUATION OF PRESERVATIVE EFFECTIVENESS IN SOME EYE DROPS IN SYRIAN MARKET BY ANTIMICROBIAL EFFECTIVENESS TEST ACCORDING TO DIFFERENT PHARMACOPEIAS | ||
| Bulletin of Pharmaceutical Sciences Assiut University | ||
| Volume 45, Issue 2, December 2022, Pages 1155-1163 PDF (1.47 M) | ||
| Document Type: Original Article | ||
| DOI: 10.21608/bfsa.2022.271828 | ||
| Authors | ||
| Reem Rajab* 1; Youssef AlAhmad2 | ||
| 1Department of Pharmaceutical Chemistry and Drug Quality Control, Faculty of Pharmacy, Al-Baath University, Homs, Syria | ||
| 2Faculty of Pharmacy, Arab University for Science and Technology (AUST), Hama, Syria | ||
| Abstract | ||
| 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). | ||
| Keywords | ||
| ophthalmic/eye drops; sterility; preservative effectiveness; microbial contamination; compendial test | ||
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