Snehyrova D. Development of the composition and standardization technology of a combined oral solution based on magnesium salts

The thesis is devoted to the choice of qualitative and quantitative composition of combined oral solutions based on organic magnesium salts, and further development of technology and standardization for obtained medicines. An original method for the synthesis of the active pharmaceutical ingredient magnesium L-lactate dihydrate from magnesium oxide and L-lactic acid by a neutralization reaction in an aqueous medium was proposed. The analytical quality of the obtained salt according to the requirements of the European Pharmacopoeia was proved. The specific optical rotation for the compound was additionally determined. The developed method is characterized by simplicity in technological execution, absence of flammable and explosive substances and high yield. The scientific knowledge about the synthesis of active pharmaceutical ingredient magnesium pidolate was widened. For the first time a cost-effective technology for this compound obtaining in the form of a concentrate from relatively cheap ingredients magnesium oxide and L-glutamic acid with formation of the intermediate product magnesium L-glutamate followed by a cyclodehydration reaction at high temperatures was proposed. The quality of the obtained salt corresponds to the indicators of the European Pharmacopoeia monograph. The technology for a generic medicine with improved quality obtaining in single-dose ampoules "Mag-M6693" was developed and standardized, a draft of methods of quality control for the medicine was developed. For the first time the original composition of the oral solution in multi-dose vials "Maglycimet" was developed. The technology of medicine preparation was developed and standardized, the project of methods of quality control was developed. According research, both the generic drug of improved quality "Mag-M6693" in single-dose ampoules and the original drug "Maglycimet" in multi-dose vials have higher pharmacological activity compared to popular analogues. The technology of the oral solution "Mag-M6693" was tested in the conditions of industrial production of the Limited Liability Company "YURIA-PHARM". The technology of oral solution "Maglycimet" was tested in the conditions of industrial production of the Private Joint-Stock Company Pharmaceutical Factory "VIOLA". The originality of the composition and technology of production of the drug "Maglycimet" is protected by a patent of Ukraine for a utility model № 134684, a positive decision to grant a patent for an invention was received, registration number of the application a 2019 00574.