Burdak K. Creation of a drug of hepatoprotective action based on the substance ademetionin in the form of tablets

The thesis is devoted to the scientific substantiation of the composition and development of the technology for obtaining the drug hepatoprotective action on the basis of the substance ademetionin in the form of tablets. A study and a comparative analysis of the physico-chemical and pharmacological-technological properties of the substance of two foreign manufacturers was carried out. The qualitative and quantitative composition of auxiliary substances was selected, their compatibility was investigated. The rational technology of nuclear core tablets and the parameters of application of for film gastric coating have been developed. The developed quality control methods for both the intermediate product and the finished product, including the methods of identification and quantification of the active substance ademetionine and its isomers and storage conditions. The performed studies made it possible to obtain a pharmaceutical equivalent tablet of the comparative drug Heptral. Approbation, technology scaling and drug development for clinical trials have been performed