Equitoxicity of domestic hydroxycarbamide and reference drug hydrea in rats

Abstract

Introduction . The appearance of high-quality and effective generics can significantly reduce the cost of health care for the drug supply of the population of Russia. According to expert estimates, the cost of treatment of cancer patients with generics of domestic can be 30– 40 % cheaper as compared to the original drugs. In Russia the pharmaceutical production company “Ozon” created by the domestic analogue of the original anticancer drug hydrea – hydroxycarbamide.
Objective: comparative study of chronic toxicity of the drug hydroxycarbamide (“Ozon”, Russia) and registered reference drug hydrea (Corden Pharma Latina S. p. A., Italy) on rats.
Materials and methods . A comparative study of the toxicity of drugs was carried out on 70 non-inbred white male rats weighing 220– 250 g obtained from the accredited laboratory animal nursery of LLC “Krolinfo”. Both drugs were administered in parallel daily orally 5-fold in 3 doses. As a solvent, 1 % starch paste was used. Doses were calculated according to the literature data on the basis of maximum tolerated dose. Standard methods of evaluation of chronic toxicity of drugs in rats were used.
Results . The obtained data on chronic toxicity of the compared forms of the domestic drug hydroxycarbamide and the reference drug hydrea do not differ significantly in terms of quantitative and qualitative toxicity (lethality, biomarkers of toxicity, morphometry of organs). Conclusion . The compared generic and commercial preparations are practically equitoxic by 5 times oral administration to rats.