Abstract
The aim. To substantiate the safety using of the new nasal spray with Enisamium Iodide via study results of acute local drug-induced irritant action of the test object single-dose to eyes and nasal cavity mucosa.Material and methods. Enisamium Iodide 10 mg/mL (nasal spray) was the test object. The reference drug was 0.9 % saline. Flemish Giant rabbits were used to induce the experiment (2 groups, 9 rabbits in each group). All study objects were administered in single-dose into the eye conjunctival sacs (0.01 mL) and nasal passages (0.1 mL) by instillation. The eye examination we performed in different time observation point (through 1, 24, 48 and 72 h after drug instillation). Nasal endoscopy was used for control of nasal cavity in all stages of study (15 minutes before, 1-hour and 24 hours after drug instillation) under general anesthesia. The scales of the assessment were used to the result objectivity.Results. The total score was 0 points in all groups at all-time points according to the relevant scale and the scale of the assessment of rabbit nasal cavity mucosa by nasal endoscopy results. This corresponds to the condition of a healthy eye and healthy nasal mucosa.Conclusions. Enisamium Iodide 10 mg/mL (nasal spray) in the single-dose instillation into the rabbit eye conjunctival sacs and rabbit nasal passages did not show local drug-induced irritant action on the eye conjunctiva and nasal cavity mucosa in the experimental animals. Nasal endoscopy could be used as an informative visual method in preclinical studies
Highlights
Rhinosinusitis (RS) is inflammation of the nasal sinuses and affects approximately 12 % of the population [1]
A significant fact in favor of intravital nasal endoscopy is that this technique allows you to more closely follow modern bioethical standards for conducting experiments on animals, causing them the least possible harm
The total score was 0 points in both groups (II a and II b) at all-time points according to the scale of the assessment of rabbit nasal cavity mucosa by nasal endoscopy results (Table 2), which corresponds to the condition of a healthy nasal cavity mucosa
Summary
Rhinosinusitis (RS) is inflammation of the nasal sinuses and affects approximately 12 % of the population [1]. Acute rhinosinusitis (ARS) is an inflammation of the nasal cavity and nasal sinuses mucosa with sudden symptom onset and duration of all symptoms up to 12 weeks. ARS is characterized by a decrease of life quality of patients with the possible development of complication (chronic RS, orbital and intracranial complications, et al.) [1,2,3]. It should be noted that most drugs for pathogenic and symptomatic treatment of the different forms of ARS (viral, post-viral and bacterial ARS) have high-level evidence and strength of recommendations. The use of drugs such as intranasal forms of corticosteroids, despite the high-level evidence in the treatment of individual forms of ARS, is not rational in the treatment of viral ARS. The use of irrigation therapy with saline solutions of various concentrations based on sea or mineralized water, despite the presence of topical forms, will not always lead to a rapid decrease in all symptoms of ARS, for example, such as facial pain
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