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Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H2 receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole (DFDB).Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control.Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC.Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out.Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.

Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shelf life for the product. The aim of this study was to compare current requirements for stability testing of medicinal products in the Russian Federation and the Eurasian Economic Union (EAEU). The study covered stability testing of small-molecule medicines. The paper describes evolution of approaches to stability testing in the Russian Federation. It summarises the main differences in basic requirements for stability testing as stipulated in the State Pharmacopoeia of the Russian Federation (Ph. Rus.) XIII edition, Ph. Rus. XIV edition, and EAEU regulations. The study demonstrated that the Russian Federation lacks regulations containing specific requirements for stability testing performed to support variations to marketing authorisation documentation. The Ph. Rus. XIV edition does not specify the extent of stability testing to be performed after switching to another manufacturer of the active ingredient or introduction into operation of a new manufacturing site where the medicinal product will be produced. At the same time, the EAEU regulatory documents contain requirements for stability testing for each type of the most frequent variations to marketing authorisation documentation. The study demonstrated the continuing relevance of bringing the Russian regulations on stability testing in line with those of the EAEU.

Aim . To study the stability of biocompatible microemulsion composition-based bromokain transdermal therapeutic systems (TTS) in order to confi rm the original shelf life and to identify the most appropriate TTS composition for storage. Materials and methods . The stability test using accelerated aging method was performed on the samples of TTS containing 50 and 100 mg of bromokain. Physicochemical properties of TTS were analyzed at the end of the 1st, 2nd, 3rd, and 6th month of storage. The physical confi guration of the dosage form, the content of bromokain in TTS, and drug release were evaluated at each stage of the study. The content of bromokain in the samples was recorded using high performance liquid chromatography (HPLC). As a control for each method, the newly manufactured TTS forms were used. Results . Unlike the samples containing 50 mg of bromokain, TTS with 100 mg of the anesthetic demonstrated changes in the physical confi guration and deterioration of the functional properties after the 6th month of storage. The quantitative content of the substance in TTS containing 50 and 100 mg of bromokain met the requirements of regulatory documentation (RD) at all phases of the experiment and was within 50,0 ± 5,0 mg and 100,0 ± 10,0 mg, respectively. The release profi le of TTS with 50 mg of bromokain has remained unchanged during storage and complies with the RD. TTS with 100 mg of bromokain after the 3rd month of storage had a deviation from the release profi le indicated in the RD. Conclusion. The shelf life of 2 years at t = 25 °C preset by us for samples of TTS containing 50 mg of bromokain has been confi rmed. According to the test results, samples of TTS with the content of bromokain of 100 mg were declared unstable and unfi t for storage under the selected storage conditions.