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

VALLE BESSONE, CAROLINA DEL; RAMIREZ, MARÍA LAURA; MARTINEZ, SOFÍA MICKAELA; VILRRUBI, SILVINA MABEL; VILLEGAS, NATALIA ÁNGEL; ALLEMANDI, DANIEL ALBERTO; QUINTEROS, DANIELA ALEJANDRA

Pharmacy & Pharmacology International Journal

MEDCRAVE

Lugar: Budapest; Año: 2021 vol. 9 p. 242 - 247

Objective: Develop sterile vancomycin-amikacin reinforced antibiotics in smallerbatches of finished products than those produced at the industrial level and under differentworking conditions. In this work, critical aspects concerning the elaboration processsuch as equipment and process evaluation, protocol development, physicochemicalcharacterization, and microbiological tests were analyzed. In the first stage, the preparationof the formulations was carried out in the Department of Pharmaceutical Sciences ofthe Faculty of Chemical Sciences of the National University of Cordoba. In the secondstage, the eye drops were prepared in the laboratory of Farmacia Vilarrubi, an officepharmacy authorized by the health authority and dedicated to the preparation of non-sterilecompounding formulations. Both samples prepared at different manufacturing sites weresubjected to the same physicochemical and microbiological tests.Methods and results: The sample compounding formulations of Vancomycin, Amikacin ortheir combination, at a dose of 30 mg/mL, were developed and subjected to physicochemicalessays such as macroscopic observation, measurement of pH, osmolality, particle size, andquantification of drug concentration, during 7 days stored under adequate conditions oflight and temperature. In addition, microbiological assays were carried out to verify theirsterility and procedure under aseptic conditions. All the formulations made of reinforcedantibiotic eye drops demonstrated high physicochemical and microbiological stabilityduring the evaluated period.Conclusion: The reinforced antibiotic eye drops and the container used for theirconservation showed correct sterility and microbiological stability during the time of usefor the patient. It is possible to transfer small batch production of this type of quality sterileformulations to a pharmacy. For this, the training and education of the pharmaceuticalprofessional is imperative.