DOI: https://doi.org/10.24959/ubphj.20.285

Study of acute toxicity of a gel containing dimethyndene maleate and dexspanthenol

T. Popova, H. Kukhtenko, D. Litkin

Abstract


Topicality. Today there is an increase in the number of cases of local allergic skin reactions to various irritants. A special category of patients are children who are highly sensitive to the bites of membranous insects and to the products of their activities. The NUPh Department of Technologies of Pharmaceutical preparations  carries out scientific work on the development of the composition of the gel containing dimethydenene maleate and dexpanthenol for the treatment of contact allergy within the scientific research activity of the department under the direction 0114U000945 «Development of composition, technology and biopharmaceutical studies of medicinal products based on natural and synthetic raw materials».

Aim. To study the acute toxicity parameters of the drug in the form of a gel containing 0.1 % dimethindene maleate and 3.0 % dexpanthenol at a single dermal application and intragastric administration.

Materials and methods. The object of the study is a combined drug in the form of a gel with proven antiallergic and reparative action. Laboratory studies have been performed on 36 white rats of both sexes. The animals were once applied to the skin and administered into the stomach (dermally – 2810 mg/kg, gastrically – 5000 mg/kg) test sample of the gel and observed, assessing the general condition. The main indicators studied during the study: survival, body weight dynamics and internal organs mass coefficients.

Results and discussion. Indicators of the dynamics of animals’ body weight for 14 days of experiment when applying and administering the test gel did not go beyond physiological norms and did not differ statistically from similar indicators in the group of intact animals. Mass coefficients of internal organs in the vast majority of cases do not differ in the studied female and male rats from intact control animals. For 14 days of the study, there was no mortality in rats of both sexes at dermal application and enteric administration. According to dose levels applied, the test gel can be classified as class IV toxicity.

Conclusions. Toxicological studies acute toxicity of the combined antiallergic and reparative gel showed that the studied composition of the gel at a single external application and intragastric administration at appropriate maximum doses of class IV toxicity by dosage form did not cause any general manifestations of toxicity in male and female rats.

Keywords


gel; dimethindene maleate; dexpanthenol; acute toxicity; toxicity class IV

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Abbreviated key title: Ukr. biopharm. j.

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