[Preclinical research on Pharmachim's ronidazole].

Area of Science:

• Veterinary Pharmacology
• Animal Toxicology
• Drug Stability

Background:

• Ronidazol-Pharmachim (RPh) is a 10% water-soluble powder.
• Understanding its toxicological profile and stability is crucial for safe application.

Purpose of the Study:

• To evaluate the stability of RPh across various pH levels.
• To determine the acute and subchronic toxicity of RPh in mammals.
• To assess residual amounts and withdrawal times in pigs.

Main Methods:

• Stability testing in aqueous solutions and acidic media (n HCl).
• Acute toxicity studies (LD50) via oral and intraperitoneal routes in rats.
• Subchronic toxicity and tolerance trials in pigs at varying doses and concentrations.
• Determination of withdrawal times in pigs.

Main Results:

• RPh demonstrated stability in water (pH 5.0-9.0) for 96 hours and in n HCl for over a month.
• Oral LD50 in rats was 34000 mg/kg; intraperitoneal LD50 was 1500 mg/kg.
• Pigs tolerated single oral doses up to 180 mg/kg and 30-day water administration up to 300 ppm without adverse effects on behavior, appetite, growth, blood, or visceral structure.
• Growth stimulation was observed at 180 ppm.
• A withdrawal time of at least 72 hours was established.

Conclusions:

• Ronidazol-Pharmachim exhibits good stability and a wide safety margin in mammals.
• The drug is well-tolerated by pigs, with no adverse effects at therapeutic and higher doses.
• A 72-hour withdrawal period is sufficient for pigs treated with RPh.