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[Pharmacological and toxicological studies of novoolean]
Abstract:
A toxicologic study and some pharmacologic investigations were carried out with the novobiocin salt of oleandomycin, formulated as novoolean. The LD50 of the of the preparation for i/m application to mice proved equal to 1500, and to rats--1800 mg per kg of body weight. For oral introduction the average lethal dose for mice amounts to 3250 mg/kg. At such route of application on deaths were observed in rats after the administration of 5 000 mg/kg. A 30-day treatment via i/m application to rats of 180 mg/kg (which is equal to one tenth part of LD50) did not lead to changes in the growth, blood picture, and a number of clinical and biochemical indices of the blood and urine; there were no changes in the development and the structure of the viscera as well as the reproductive capacity of the test animals. Electron-microscope studies with rats treated in the same period with 360 mg/kg (one fifth of the LD50 value) revealed certain injuries of the liver kidneys. With cats the venous infusion of the preparation at rates of up to 15 mg/kg showed no changes in the blood pressure and the rhythm and pulse rate, and the addition of novoolean to the nutrient solution in concentrations of up to 100 mg/cu. cm did not influence the tonus and the motor function of isolated (after Magnus) sectioned portions of the small intestine of rabbits and guinea pigs.
Insights
Novoolean, an oleandomycin and novobiocin formulation, showed low toxicity in rodent models. Higher doses in rats caused liver and kidney damage, but no adverse effects were observed in cardiovascular or gastrointestinal studies.
Area of Science:
- Pharmacology
- Toxicology
Context:
- Novoolean is a novel formulation combining oleandomycin and novobiocin.
- Understanding the toxicological and pharmacological profile of new drug formulations is crucial for safety assessment.
Purpose:
- To evaluate the toxicological and pharmacological properties of novoolean.
- To determine the lethal dose (LD50) and assess potential adverse effects in various animal models.
Summary:
- Novoolean exhibited moderate acute toxicity with LD50 values of 1500 mg/kg (intramuscular, mice) and 1800 mg/kg (intramuscular, rats). Oral administration showed higher lethal doses.
- Subchronic intramuscular administration in rats at 1/10th LD50 did not induce significant toxicity. However, at 1/5th LD50, electron microscopy revealed liver and kidney injuries.
- Pharmacological studies in cats indicated no cardiovascular effects (blood pressure, heart rate) with intravenous infusion. In vitro studies on isolated intestinal segments of rabbits and guinea pigs showed no impact on tonus or motility.
Impact:
- This study provides essential safety data for novoolean, informing its potential therapeutic applications and guiding further preclinical and clinical development.
- The findings highlight the dose-dependent toxicity of novoolean, particularly concerning liver and kidney function at higher exposure levels.