Approaches to the definition of macromolecular aggregates in glatiramoids

Abstract

The approaches to the selection of the optimal chromatographic conditions to assess the content of high molecular weight aggregates in glatiramer acetate - compounds belonging to nonbiological medicines of complex chemical structure - are described. It is found that accelerated aggregate formation occurs under stringent conditions, and in this case it is accompanied by a change in the molecular weight distribution of a basic compound. The number of aggregates formed relatively small. Samples not subjected to accelerated aging are substantially free of aggregates. Clarification of the composition and the molecular weight of the resulting units, as well as an assessment of their stability, is the subject of further research, which will recommend approaches to standardization of pharmaceutical preparations containing glatiramer acetate.

Keywords

• глатирамоиды
• глатирамера ацетат
• эксклюзионная хроматография
• высокомолекулярные соединения
• агрегаты
• glatiramoids
• glatiramer acetate
• size-exclusion chromatography
• macromolecular compounds
• aggregates