QUANTIFICAÇÃO DE METAIS E METALOIDES EM AMOSTRAS COMERCIAIS DE COLÍRIOS UTILIZADOS NO TRATAMENTO DE GLAUCOMA NO BRASIL

Abstract

Glaucoma is one of the leading causes of irreversible blindness worldwide, requiring continuous use of eye drops to control intraocular pressure. However, the presence of metals and metalloids in ophthalmic formulations has been little investigated. In this study, aluminum (Al), arsenic (As), barium (Ba), cadmium (Cd), cobalt (Co), chromium (Cr), copper (Cu), iron (Fe), magnesium (Mg), manganese (Mn), molybdenum (Mo), nickel (Ni), lead (Pb), selenium (Se), vanadium (V), and zinc (Zn) in commercial samples of eye drops for glaucoma. A total of 50 samples were purchased from commercial outlets and analyzed using inductively coupled plasma optical emission spectrometry (ICP-OES). The results obtained were compared with the limits established by national and international regulatory agencies. Concentrations varied between manufacturers, with the following standing out: Al (0.2636±0.0179 and 0.1001±0.0050 mg/kg), Cd (0.0394±0.0054 and 0.0093±0.0050 mg/kg), Cr (0.0385± 0.0114 and 0.0102± 0.0115 mg/kg), Mg (4.3968 ±0.3553 and 0.0093±0.0252 mg/kg), Se (0.1191±0.0029 and 0.0290±0.0024 mg/kg), and Zn (0.1030±0.1247 0.0589±0.0257 mg/kg). Compared to the limits established by the Brazilian Pharmacopoeia and ICH Q3D (R2) for parenteral drugs, the values found for Cd were well above the standard. The calculated permissible daily exposure (PDE) indicates the need for specific standardization for ophthalmic products, since there are no exclusive limits for this route of administration. The results reinforce the importance of systematic monitoring, improvement of manufacturing processes, and updating of legislation to ensure patient safety.