PHARMACEUTICAL AND TECHNOLOGICAL EVALUATION OF THE SUBSTANCE AND TABLET MASS OF FLACOSIDE

Flacoside substance with the active ingredient "fellamurin" is an individual natural flavonoid glycoside isolated from the leaves of Amur cork tree, possessing antiviral, hepatoprotective, antioxidant, immunostimulating activity, from which in the 1980s VILAR employees developed the composition and technology of tablets, launched industrial production, which made it possible to use them in the treatment of chronic liver and biliary tract diseases of various origins. However, in the 1990s, the production of the drug was suspended, but the COVID-19 pandemic contributed to the ac-tualization of this development. The aim of the work is to determine the pharmaceutical and technological parameters of the substance and tablet mass of flacoside, to establish their compliance with the requirements of the State Pharmacopoeia of Russia, XV edition, and to identify ways to improve the technology for obtaining tablets to resume production of the drug. The technological parameters of the flacoside substance and the tablet mass obtained by wet granulation (in accordance with the previously developed Technological Regulations) were compared. The results of laser diffractometry, sieve analysis and optical microscopy showed that as a result of granu-lation, the particle size of the tablet mass increases significantly (from 0.02 mm to 1.3-1.5 mm). The bulk density before and after compaction, as well as the angle of natural repose, corresponded to those obtained in the 1980s, which confirms the pharmaceutical and technological identity of the flacoside substance obtained in 2022. A comprehensive pharmaceutical and technological assessment of powders based on 12 parameters, processed using the SeDeM expert system method, showed that the good compression index (GCI) of the flacoside substance, which is not suitable for direct pressing, increases by 1.30 (4.43 → 5.73) as a result of granulation, and the resulting tablet mass can be used for industrial pressing.