Investigation of stability of intrauterine aerosol preparation “Yodozol”
Abstract
For standardization, quality control, study of stability and establishment of storage conditions and terms of use, complex preclinical trials of the new development of PE “Biopharm” and the Experimental Station of Epizootology IVM NAAN – aerosol preparation “Yodozol” have been carried out. The methods of evaluation of a medicinal product applied to aerosols are used, which include: determination of changes in appearance, inspection of packaging for leakproofness, measurement of the percentage of contents of the package, the establishment of qualitative and quantitative indicators of active substances, and also the study of microbiological purity of the product. “Yodozol” is a light yellow liquid, 1 ml of which contains 5 mg of iodine and 10 mg of potassium iodide. The drug is used for the prevention and treatment of postnatal intrauterine infections in cows, pigs, sheep and goats (endometritis, pyrometers, cervicitis, vaginitis, delayed digestion caused by microorganisms sensitive to iodine), after obstetrics aid, cesarean section and postpartum sanitation of the uterus. The drug has antimicrobial, anti-inflammatory and analgesic effects, improves the proliferative processes of the genital organs, reduces the time for recovery of animals. The drug is used according to the guidelines, after its production livestock is used without restrictions. The shelf-life, which is the result of the test of the dasg according to the «stability» indicator, has been determined, which was performed under long-term storage in a place protected from light at a temperature range from + 5 ± 2 °С to + 25 ± 2 °С. The studies conducted after 6, 12, 24 and 30 months showed complete compliance of the quality indices with the declared standards when stored for 24 months in the temperature corridor from + 5 °C to + 20 °C. With an increase in storage temperature to + 25 °C or more, a slight quantitative decrease in the concentration of antimicrobial components occurred. In addition, with long-term storage of drugs, release of the contents from the cylinder became uneven and foam acquired a shade less than the saturation rate, increased microbiological contamination. Thus, according to the results of the study, the established shelf life of the preparation is 2 years at the recommended storage temperature from +5 to +20 °С. All studies conducted on the stability of the aerosol intrauterine drug “Yodozol” were included in the registration materials of the medicinal product.
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