The Study of comparative kinetics of dissolution of a drug based on robenacoxib in accordance with the EAEU procedure

Abstract

A comparative test of the kinetics of dissolution of drugs based on robenacoxib from foreign and domestic manufacturers was carried out in three dissolution media modeling the main sections of the animal's gastrointestinal tract, and in the dissolution medium according to the ND of Apicenna LLC. The purpose of this study was to compare the kinetics of dissolution of several robenacoxib-based dosage forms registered or being developed for use in the EAEU countries, in accordance with current regulatory requirements. The quantitative determination of the released active substance was carried out by high performance liquid chromatography (HPLC) at a wavelength of 275 nm. The experiments were performed on a Paddle Mixer, with sampling points corresponding to 5, 10, 15, and 30 minutes. The results showed that the optimal dissolution medium for robenacoxib is a phosphate buffer solution with a pH of 6.8, which ensures the best release of the active pharmaceutical ingredient. According to the ranking results, based on the calculated similarity factors, the following drugs are most equivalent to comparison drugs: LP 3, LP 5, LP 1, LP 4, LP 2 in decreasing order. The conducted research deepens the understanding of the biopharmaceutical properties of robenacoxib and contributes to the development of a scientifically based regulatory approach to assessing the quality of veterinary drugs in the EAEU space.