Determination of stability of utero-tonic drug «Uteroedev»
Journal Title: Бюлетень "Ветеринарна біотехнологія" - Year 2018, Vol 33, Issue
Abstract
Introduction. A mandatory condition for the registration of a new drug «Uterodev», which is intended to stimulate reproductive activity, in the treatment of gynecological pathologies and improvement fertilization of animals is to study its stability during shelf life. The study of the expiration date of new drugs in order to obtain information on quality changes over time under the influence of environmental factors (temperature, humidity, illumination, etc.) is a mandatory type of tests. The goal of the work was to study the stability of the injectable drug «Uterodev» during shelf life in vials of dark glass in commercial packaging (cardboard boxes). Materials and methods. Studies on determining the shelf life of the drug «Uterodev» were conducted at a temperature condition up to 25°C and at a relative humidity of 60±5% during 27 months and one day after the opening. In order to evaluate the quality of the drug «Uterodev», its organoleptic parameters (appearance, color, presence of sediment, etc.), concentration of propranolol hydrochloride according to Kartamyshev S.V. (2002) and microbial contamination according to the methods described in the State Pharmacopoeia of Ukraine were determined. Results of research and discussion. The drug «Uterodev» is a colorless solution for injection. Throughout the experiment, changes in composition of the drug were not observed, qualitative tests on the main groups of biologically active substances confirmed the stability of the drug. During tests, changes in pH level and propranolol hydrochloride content of the experimental drug samples were within acceptable range, and microbial contamination was not registered. Analysis of the results of the microbial contamination test showed that all samples did not contain bacteria Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa. The microscopic fungi in all samples under different temperature regimes was not registered during the entire storage time, and in one day after the package opening its number was less than 10 CFU/ml. Test drug meets the requirements of the State Pharmacopoeia of Ukraine regarding microbiological purity requirement. At present, the established shelf life of the drug is 2 years, but the study was carried out in one day after the opening and next 3 months, so it was confirmed that for storage of medicinal products it is necessary to take into account several additional months after the expiration date. The stability of the developed drug is archived due to the presence of benzyl alcohol in the extractant, which simultaneously serves as a preservative. Conclusions and prospects for further research. The optimum storage conditions of the drug in containers made of dark glassware determined which are up to 25 °C and a relative humidity of 60±5% that corresponds to our climatic conditions. The obtained experimental data indicated that the shelf life for the drug «Uterodev» was more than 2 years. During the tests of pH indexes variability, the content of propranolol hydrochloride and microbial contamination of the experimental samples of the drug were within acceptable ranges. The stability of «Uterodev» is archived due to the presence of the benzyl alcohol as preservative. The results of the experiment were used during developing normative documentation for the drug. Further research will be the next stage of pre-registration tests aimed at conducting clinical trials of the injectable drug «Uterodev» on target animals.
Authors and Affiliations
Roman Sachuk, Sergii Zhyhaliuk, Olga Kulinich, Lyubov Kalinovskaya, Orest Katsaraba
Keywords
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- EP ID EP411592
- DOI 10.31073/vet_biotech33-15
- Views 155
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