The aim of the study was to evaluate the presence of metal(loid)s in lubricating eye drops used in the treatment of dry eye disease. The concentrations of Al, As, Ba, Cd, Co, Cu, Cr, Pb, Fe, Mg, Mn, Mo, Ni, Se, V, and Zn were determined in 19 eye drop samples using inductively coupled plasma optical emission spectrometry (ICP OES). The limit of detection (LOD) and limit of quantification (LOQ) values for the quantified elements ranged from 0.0002–0.0363 (mg/L) and 0.0007–0.1211 (mg/L), respectively. High values of concentrations of Al (2.382 µg/g), As (0.204 µg/g), Ba (0.056 µg/g), Cd (0.051 µg/g), Co (1.085 µg/g), Cr (0.020 µg/g), Cu (0.023 µg/g), Fe (0.453 µg/g), Mg (24.284 µg/g), Mn (0.014 µg/g), Mo (0.046 µg/g), Ni (0.071 µg/g), Pb (0.049 µg/g), Se (0.365 µg/g), V (0.083 µg/g), and Zn (0.552 µg/g) were quantified in samples of eye drops with and without preservatives. The concentrations of As (5 samples) and Cd (3 samples) were higher than those allowed by the Brazilian Pharmacopoeia for impurities (parenteral use). The value of Co content (µg/g) in a sample was higher than the value established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH Q3D (R2)) in the parenteral route. The daily eye drop instillation exposure (µg/day) was below the values from the parenteral-permitted daily exposure (PDE) set by the ICH Q3D guideline (R2). The presence of heavy metals in eye drops is an alert to regulatory agencies in several countries so that control and inspections can be carried out.

Lithium carbonate is one of the most prescribed mood stabilizers worldwide and remains the first-line pharmacological treatment for bipolar disorder (BD). Its therapeutic efficacy is well established; however, lithium (Li) has a narrow therapeutic index, and prolonged or excessive intake can cause renal, neurological, or endocrine toxicity. In Brazil and globally, lithium-based formulations are widely commercialized; however, only Brazil adopts a specific regulatory classification distinguishing reference, generic, and similar medicines. Despite its extensive clinical use, studies monitoring the actual Li concentration in pharmaceutical products are extremely scarce. This study quantified Li concentrations in different formulations available in Brazil to evaluate their chemical uniformity, estimated daily intake, and potential health risks. Samples were digested and analyzed using Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES). Statistical analysis with the Kruskal–Wallis test revealed significant differences among formulations (p = 0.012), confirming non-uniform Li content. Measured concentrations ranged from 245.47 to 315.24 mg/kg, with generic products showing the highest values. The calculated daily intake (DI) and chronic daily intake (CDI) increased with therapeutic dose (600–1800 mg/day), and higher-dose regimens frequently exceeded the permitted daily exposure (PDE) value for Li established by International Council for Harmonisation Guideline for Elemental Impurities (Revision 2) (ICH Q3D (R2) (0.55 mg/day). Moreover, hazard quotient (HQ) values above 1 in some scenarios indicated potential health risks associated with excessive or long-term Li exposure. As one of the first studies to quantify Li in marketed formulations, this work underscores the need for systematic monitoring and stricter quality control to ensure therapeutic safety.

The study aimed to evaluate the effect of baru oil (Dipteryx alata Vog) supplementation on maternal milk and offspring of female Wistar rats. Animals were divided into three groups (n = 12), supplemented with baru oil, soybean oil, or olive oil, at a daily dose of 1,000 mg/kg during pregnancy and lactation. The body weights and food intake of rats were measured weekly and analyzed. Milk collection was performed manually from the 12th to the 21st day of lactation. After weaning, rats and pups were euthanized after a 6-h fast. Blood was collected from the animals, five sites of adipose tissue were removed from each mother rat, and the mesenteric site was removed from the pups. It was observed that breast milk from the group supplemented with baru oil had higher concentrations of polyunsaturated and monounsaturated fatty acids, such as linoleic and oleic acids. However, there was no statistical difference between the group supplemented with Baru and soybean oil or olive oil group. Supplementation of the three types of oils did not interfere with body weight gain, animal consumption, serum parameters, liver weight, and adipose tissue sites. However, it showed antiatherogenic activity.

Dry eye disease is a common condition in which tear production or quality is insufficient to lubricate the eyes properly. Standard treatment usually involves lubricating eye drops. In this study, we assessed the human health risks, including both non-carcinogenic and carcinogenic effects, associated with long-term exposure to the chemical elements arsenic (As), cadmium (Cd), cobalt (Co), iron (Fe), nickel (Ni), lead (Pb), and zinc (Zn) in eye drops used in Brazil. The results indicated that the Co concentration (1.1048 mg/kg) in the eye drops sample 5 exceeded the limit established by the ICH Q3D (R2) guideline for parenteral products (0.5000 mg/kg). Additionally, As levels in eye drop samples 2, 8–10, 12, 13, and 16, as well as Cd levels in samples 2, 3, 8–10, and 12, exceeded the limits established by the Brazilian Pharmacopoeia for parenteral administration (0.0500–0.0532 mg/kg). The main health risk appears to come from oral exposure, as the drug can drain into the nasal cavity via the nasolacrimal duct and then be absorbed through the gastrointestinal tract. While none of the tested eye drops posed non-carcinogenic risks, carcinogenic risks from oral exposure to As and Cd were identified, with overall risk levels exceeding acceptable thresholds. These findings emphasize the need for strict regulation and continuous monitoring of these products to reduce health risks and prevent long-term damage.