title: Evaluation of the in vitro ocular toxicity of the fortified antibiotic eye drops prepared at the Hospital Pharmacy Departments.
abstract: The use of parenteral antibiotic eye drop formulations with non-marketed compositions or concentrations, commonly called fortified antibiotic eye drops, is a common practice in Ophthalmology in the hospital setting. The aim of this study was to evaluate the in vitro ocular toxicity of the main fortified antibiotic eye drops prepared in the Hospital Pharmacy Departments. We have conducted an in vitro experimental study in order to test the toxicity of gentamicin, amikacin, cefazolin, ceftazidime, vancomycin, colistimethate sodium and imipenem-cilastatin eye drops; their cytotoxicity and acute tissue irritation have been evaluated. Cell-based assays were performed on human stromal keratocytes, using a cell-based impedance biosensor system [xCELLigence Real-Time System Cell Analyzer (RTCA)], and the Hen's Egg Test for the ocular irritation tests. All the eye drops, except for vancomycin and imipenem, have shown a cytotoxic effect dependent on concentration and time; higher concentrations and longer exposure times will cause a steeper decline in the population of stromal keratocytes. Vancomycin showed a major initial cytotoxic effect, which was reverted over time; and imipenem appeared as a non-toxic compound for stromal cells. The eye drops with the highest irritating effect on the ocular surface were gentamicin and vancomycin. Those antibiotic eye drops prepared at the Hospital Pharmacy Departments included in this study were considered as compounds potentially cytotoxic for the ocular surface; this toxicity was dependent on the concentration used.
authors: Pharmacy Unit, Xerencia de Xestión Integrada of Santiago de Compostela, SERGAS, Santiago de Compostela. Clinical Pharmacology Group, Health Research Institute (IDIS-ISCIII), Santiago de Compostela. Department of Pharmacy and Pharmaceutical Technology. School of Pharmacy, Universidad de Santiago de Compostela, Santiago de Compostela.. anxordes@gmail.com.
authors: Anxo
authors: A
authors: Fernández-Ferreiro
authors: Pharmacy Unit, Xerencia de Xestión Integrada of Santiago de Compostela, SERGAS, Santiago de Compostela. Clinical Pharmacology Group, Health Research Institute (IDIS-ISCIII), Santiago de Compostela.. anxordes@gmail.com.
authors: Miguel
authors: M
authors: González-Barcia
authors: Ophthalmology Unit, Xerencia de Xestión Integrada of Santiago de Compostela, Santiago de Compostela. Ophthalmological Institute Gómez-Ulla, Santiago de Compostela.. anxordes@gmail.com.
authors: María
authors: M
authors: Gil-Martínez
authors: Ophthalmology Unit, Xerencia de Xestión Integrada of Santiago de Compostela, Santiago de Compostela.. anxordes@gmail.com.
authors: María
authors: M
authors: Santiago Varela
authors: Obesidomics Group, Health Research Institute (IDIS-ISCIII), SERGAS, Santiago de Compostela. Spain.. anxordes@gmail.com.
authors: María
authors: M
authors: Pardo
authors: Department of Pharmacy and Pharmaceutical Technology. School of Pharmacy, Universidad de Santiago de Compostela, Santiago de Compostela. Industrial Pharmacy Institute, Universidad de Santiago de Compostela (USC), Santiago de Compostela.. anxordes@gmail.com.
authors: José
authors: J
authors: Blanco-Méndez
authors: Ophthalmology Unit, Xerencia de Xestión Integrada of Santiago de Compostela, Santiago de Compostela.. anxordes@gmail.com.
authors: Antonio
authors: A
authors: Piñeiro-Ces
authors: Pharmacy Unit, Xerencia de Xestión Integrada of Santiago de Compostela, SERGAS, Santiago de Compostela. Clinical Pharmacology Group, Health Research Institute (IDIS-ISCIII), Santiago de Compostela.. maria.jesus.lamas.díaz@sergas.es.
authors: María Jesús
authors: MJ
authors: Lamas Díaz
authors: Department of Pharmacy and Pharmaceutical Technology. School of Pharmacy, Universidad de Santiago de Compostela, Santiago de Compostela. Industrial Pharmacy Institute, Universidad de Santiago de Compostela (USC), Santiago de Compostela.. anxordes@gmail.com.
authors: Francisco J
authors: FJ
authors: Otero-Espinar
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001681:Biological Assay; D002478:Cells, Cultured; D002642:Chick Embryo; D002645:Chickens; D004339:Drug Compounding; D005131:Eye Injuries / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D015603:Keratinocytes / Q000187:drug effects; D009883:Ophthalmic Solutions; D010607:Pharmacy Service, Hospital
chemical_list: D000900:Anti-Bacterial Agents; D009883:Ophthalmic Solutions