Design and development of reinforced antibiotic eye drops in a community pharmacy

Abstract

Develop sterile vancomycin-amikacin reinforced antibiotics in smaller batches of finished products than those produced at the industrial level and under different working conditions. In this work, critical aspects concerning the elaboration process such as equipment and process evaluation, protocol development, physicochemical characterization, and microbiological tests were analyzed. In the first stage, the preparation of the formulations was carried out in the Department of Pharmaceutical Sciences of the Faculty of Chemical Sciences of the National University of Cordoba. In the second stage, the eye drops were prepared in the laboratory of Farmacia Vilarrubi, an office pharmacy authorized by the health authority and dedicated to the preparation of non-sterile compounding formulations. Both samples prepared at different manufacturing sites were subjected to the same physicochemical and microbiological tests. Methods and results: The sample compounding formulations of Vancomycin, Amikacin or their combination, at a dose of 30 mg/mL, were developed and subjected to physicochemical essays such as macroscopic observation, measurement of pH, osmolality, particle size, and quantification of drug concentration, during 7 days stored under adequate conditions of light and temperature. In addition, microbiological assays were carried out to verify their sterility and procedure under aseptic conditions. All the formulations made of reinforced antibiotic eye drops demonstrated high physicochemical and microbiological stability during the evaluated period.Conclusion: The reinforced antibiotic eye drops and the container used for their conservation showed correct sterility and microbiological stability during the time of use for the patient. It is possible to transfer small batch production of this type of quality sterile formulations to a pharmacy. For this, the training and education of the pharmaceutical professional is imperative.