Glatiramer acetate: comparison of quality control methodologies in products commercialized in Argentina
DOI:
https://doi.org/10.62035/rca.1.13Keywords:
glatiramer acetate, immunomodulator, synthetic peptide, quality controlAbstract
Glatiramer acetate is a synthetic peptide within the group of non-biological complex drugs, and it is indicated as an immunomodulator for the treatment of multiple sclerosis. Currently, there are three products which are commercialized in the national market that contain glatiramer acetate as the active ingredient, all of them in the form of pharmaceutical injectable solution. The objective of this work is to perform a survey of the tests carried out in their quality control. For this purpose, the database of registration procedures of the National Administration of Medicines, Food and Medical Technology was explored, and a bibliographic search on the subject was carried out as well. After analyzing the different control methods, it was shown that all the owning laboratories carry out general tests for the injectable solution form, while in relation to the analyses related exclusively to the nature of the active pharmaceutical ingredient, some differences were observed in the tests to be carried out. The challenge then remains to define the tests that should be mandatory in the quality control of these products. The registration records of the currently marketed products are an extremely useful tool for this purpose. This survey creates a scenario that allows to project and work to combine and define the specifications and minimum technical requirements to be considered necessary.
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