Pharmacological studies of the veterinary medicinal product “Dibutalastin Ointment”

Abstract

The study of pharmacological studies of the veterinary medicinal product for external use in the form of ointment – “Dibutalastin Ointment” is a mandatory stage of preclinical research of the drug, which is a new development of PP “Biopharm” and LLC “DEVIE”. In a scientific experiment on laboratory animals, it is possible to assess the drug's safety for different terms of use to determine the zone of toxic action and doses that do not cause harmful effects on health. Therefore, the work aimed to carry out pharmacological studies of the drug with methyl salicylate and dimethyl sulfoxide in the form of an ointment for treating European fallow deer, deer, dogs, and cats with mastitis, arthritis, myositis, and injuries of various origins. The toxicological characteristics of the studied ointment “Dibutalastin” based on methyl salicylate and dimethyl sulfoxide were studied in an "acute" study on warm-blooded animals. The average lethal dose (LD50) for intragastric administration could not be established, as the volume exceeded the permissible level. It was established that according to the “average lethal dose when entering the stomach” indicator, the veterinary medicinal product belongs to relatively non-toxic substances (toxicity class IV). The results of pharmacological studies indicate the absence of resorptive-toxic effects, sensitizing properties, and irritating effects on the mucous membranes of the eyes and skin. Pathomorphological studies of animal organs when studying the acute toxicity of the drug showed that the developed ointment with methyl salicylate and dimethyl sulfoxide does not cause pathological changes in internal organs. From the point of view of veterinary toxicology, this drug is safe. Further studies will be the next stage of pre-registration tests aimed at studying the embryotoxic effect of “Dibutalastin Ointment”, which is mandatory material of the “Safety and residue studies” section of the dossier for this medicinal product.