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.
About the Authors
Yu. V. Olefir
Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
A. I. Lutseva
Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
O. A. Vaganova
Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
A. A. Bendryshev
Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
T. A. Efremova
Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
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Review
For citations:
Olefir Yu.V., Lutseva A.I., Vaganova O.A., Bendryshev A.A., Efremova T.A. Approaches to the definition of macromolecular aggregates in glatiramoids. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(4):16-19. (In Russ.)
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