Investigations into the investigational drug "Ferosel T" prior to human testing

Abstract

Preclinical research findings on the novel ferrum and selenium-containing ferrodextran formulation "Ferosel T" are discussed. It has been shown that ferrocellus T, when given orally to laboratory rats for three consecutive days, does not cause any harmful effects at either the preventive dosage of 2 ml/kg b.w. or the therapeutic dose of 4 ml/kg. The introduction of T ferrocellus into the stomach at dosages 3 and 10 times greater than therapeutic ones has been shown to have no harmful impact. Lab animals given a dosage of 10 ml/kg b.w. subcutaneously showed only temporary inhibition, and white rats were not found to die under these settings. The medicine was shown to have no effect on the liver's detoxifying capabilities at either the preventative or optimum therapeutic levels. Hexenal sleep time was 32 and 35% longer than control values in rats given maximal thera- peutic and potentially lethal dosages of ferrocellus T. Studies on the emotional and behavioral responses of rats exposed to therapeutic and maximal therapeutic dosages of ferrocel- lus T for 21 days revealed no discernible impact on the central nervous system. Prophylactic and therapeutic dosages of ferrocellus T applied to rabbit skin did not result in local irritation, as measured by hyperemia, swelling of the skin, and skin thickness. Injecting 0.1 ml of the medication "Ferosel T" sub-planarly into guinea pigs did not result in any paw swelling. Research on the medicine "Ferosel T" revealed no evidence of allergenic characteristics. The effects of prophylactic administration of ferrosel T on the heart, liver, spleen, and kidney weights of laboratory rats have not been determined. The spleen and liver weights of ferrocellus T-treated rats were 10.3 and 6.4% larger, respectively, compared to those of control rats. The spleen and liver both grew by 14.0 and 15.0% in mass when ferrocellus T was introduced at the maximal therapeutic dosage. Preventative and therapeutic usage of "Ferosel T" in animals has been shown to be safe in investigations.