Pharmaco-technological research and stability of the drug for the treat-ment and prevention of vitamin and trace element deficiency in animals

Abstract

The article presents the research results on the Development of manufacturing technology and the study of the stability of a solution for oral use based on carnitine hydrochloride, vitamins – E, B12, choline chloride, selenium, and zinc. “Devivit Carnitine” oral is used for the prevention of diseases of liver and muscle tissue metabolism in farm animals and poultry, nephrosis, myocarditis, prevention of stress (heat, transport, sound, food, post-vaccination, etc.), and prevention of vitamin and hypovitaminosis. When developing the drug technology, experimentally obtained pharmaco-technological properties of active substances and excipients were taken into account. The technological process of preparing an oral solution consists of four technological stages: preparation of canisters for filling, preparation of the solution, filling containers with medicine and packaging. The stability and shelf life of “Devivit Carnitine” (solution for oral use) in plastic canisters were determined. It was established that the drug sample in plastic canisters was stable, according to all quality control methods indicators, during the entire period of the study. The shelf life of the medicinal product with carnitine hydrochloride, vitamins E and B12, choline chloride, selenium, and zinc is 12 months. In the future, a study of preclinical data is planned to verify whether the drug does not reveal a particular hazard for animals based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and developmental toxicity.