PRECLINICAL SAFETY STUDIES (ACUTE AND CHRONIC TOXICITY) OF A POTENTIAL DRUG BASED ON PEPTIDERGIC NEURO AND STRESS PROTECTOR
The purpose of this work was preclinical studies of the safety of the potential drug "Lyzargam, nasal spray dosated" based on peptidergic neuro- and stress protector for the treatment of cerebral circulatory disorders. Preclinical investigation were carried out in the State Research Institute oh Highly Pure Biopreparations. A previous study of the specific pharmacological activity of this potential drug showed its high neuroprotecting efficacy in vivo. In assessing possible acute toxicity with the intranasal route of administration, it has been demonstrated that doses of the potential drug in 2500 and 1250 times greater than the intended therapeutic dose for humans are no toxic for mice and rats and for rabbits correspondingly. A study of the acute toxicity of the potential drug (when administered intravenously) showed that doses of the potential drug, exceeding the estimated therapeutic dose for humans in 25000 times for mice and rats and in 20000 times for rabbits, have a toxic effect, but no lethal effects are observed. Evaluation of a possible local irritant and pyrogenic effect has shown that the studied potential drug is non-pyrogenic and does not have a local irritant effect. A preclinical study of chronic toxicity showed that doses of the potential drug “Lyzargam” up to 5 mg / kg (250 times greater than the therapeutic dose for humans) when administered daily for 90 days are completely non-toxic to laboratory animals. The calculation of the safety index showed that the potential drug belongs to the class III low-hazard drugs. Thus, the results of this work may be used under investigation of clinical safety of “Lyzargam”.