Дисперсионный анализ в подборе вспомогательных веществ для создания лиофилизированной лекарственной формы с субстанцией ГК-2

An increase in the number of neurodegenerative diseases indicates the need to develop new, effective neuroprotective drugs. In the FSBI «Research Institute of Pharmacology named after V. V. Zakusov». A low-molecular dipeptide mimetic of the 4th patch NGF-hexamethylenediamide bis- (monosuccinyl-glutamyl-lysine) synthesized by the Institute, which received the working code GK-2. Due to the peptide structure and correspondingly high thermolability and hydrolytic activity of the pharmaceutical substance (FS), the development of a dosage form of lyophilizate for the preparation of injections has been proposed. The key stage in the formulation of the composition and technology was the optimization of the composition with the help of the analysis of variance with the detection of the degree of influence of each factor on the optimization parameters, in this case the technological properties such as the rehydration time, the degree of pH change after lyophilization, residual moisture, the amount of PS after lyophilization and resistance mass transfer of water model compositions. The estimation of optimization parameters for each factor of the technological process is also given separately.