Ex Vivo Irritation Evaluation of a Novel Brimonidine Nanoemulsion Using the Hen's Egg Test on Chorioallantoic Membrane (HET-CAM).

Introduction: The hen's egg test on chorioallantoic membrane (HET-CAM) assay is a cost-effective and well-validated, non-animal-based ex vivo method for evaluating the irritant potential and eye toxicity of substances. A colloidal dispersion of a surfactant and a cosurfactant with a nanosize range is called a nanoemulsion (NE), which is formed by mixing immiscible liquids and stabilized by surfactants. Patients with glaucoma are commonly prescribed Brimonidine (BR), an alpha-2 adrenergic agonist, to lower their intraocular pressure.
Materials and Methods: In this study, surfactant-cosurfactant blends were prepared by mixing Tween 80 (surfactant) and propylene glycol (cosurfactant) in a 4:1(v/v) ratio. Triacetin served as the oil phase, while deionized water was used as the aqueous phase. Using the drop method, a range of NE formulations (F1, F2, F3, FB1, FB2, and FB3) were developed and subsequently evaluated for their potential to irritate, and then the results were compared to those of a commercially available BR eye drop formulation.
Results: According to the average cumulative HET-CAM test scores (IS), from excipients, propylene glycol caused moderate irritation by causing slight damage to blood vessels. The formulations FB1 and F1 were found to have the highest level of irritation among other formulations in the investigation, recording 1.05 ±0.07 and 1.2 ±0.10, respectively. All other NE formulations exhibited non-irritating potential, as confirmed by the HET-CAM test, and were comparable to the marketed BR eye drop formulation.
Conclusion: The NE formulations created for BR were determined to be safe and non-irritating. The findings indicate that the prepared NE could be a beneficial solution for addressing problems with conventional eye drops and delivering BR effectively to the eyes.
Competing Interests: Human subjects: All authors have confirmed that this study did not involve human participants or tissue. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
(Copyright © 2024, Smail et al.)