Challenge Test: Inspection of multidose ophthalmic solutions with preservatives in the formulation for the treatment of glaucoma, marketed in Argentina according to the list of the National Vademecum of Medicines (2020-2022)

Abstract

Multidose ophthalmic solutions are sterile products intended for instillation in the eye for therapeutic purposes. The formulations must maintain consistent microbiological quality throughout their shelf life, as microbial contamination can lead to alterations in the product and cause serious eye infections. The study evaluated ophthalmic solutions with preservatives in the formulation for the treatment of glaucoma, marketed in Argentina based on data collected from the National Vademecum of Medicines during the period 2020-2022. A horizontal sampling was carried out through product control. A total of 17 establishments were inspected, in which 49 medicinal products were examined. The samples requested were analyzed through the challenge test, according to the guidelines established in Chapter of the first supplement of the Argentine Pharmacopoeia, 7th edition, at the facilities of the Microbiological Laboratory Service of the National Institute of Medicines. The results showed that 94 % of the trials complied with the pharmacopoeial specifications. Regarding the unsatisfactory ones, it was observed that the pharmacopoeial acceptance criteria for the microorganism Pseudomonas aeruginosa were not met.