Abstract
Monocyte Activation Test (MAT) is thought to be a good replacement for rabbit pyrogen test (RPT); however, MAT remains controversial. MAT was not adequately evaluated in a sufficient number of products, and there is no sufficient data that support the ability of MAT to detect non-endotoxin pyrogens. Furthermore, MAT was used subject to validation for each specific product. The aim of this study was to identify in main pharmacopoeias, whose monographs require pyrogenicity tests, and propose those products for which only the rabbit pyrogen test is required to be used as a kick-off study for future studies. Products’ monographs in pharmacopeias in the United States, Europe, and Brazil that are recommended for RPT or Bacterial Endotoxins Test (BET) are as follows. RPT: 20 in American, 37 in European, and 28 in Brazilian pharmacopoeias. BET: 619 in American, 157 in European, and 41 in Brazilian pharmacopoeias. Four products require pyrogenicity testing in three pharmacopoeias. Both RPT and BET are recommended by six monographs in Brazilian pharmacopeias and 15 in European pharmacopoeias. In Brazilian pharmacopoeias most are biological. These products should be the first to be tested for their applicability to MAT because they are currently tested mainly by RPT.
Highlights
Monocyte Activation Test (MAT) is thought to be a good replacement for rabbit pyrogen test (RPT); MAT remains controversial
Both RPT and Bacterial Endotoxins Test (BET) are recommended by six monographs in Brazilian pharmacopeias and 15 in European pharmacopoeias
In Brazilian pharmacopoeias most are biological. These products should be the first to be tested for their applicability to MAT because they are currently tested mainly by RPT
Summary
A utilização do MAT como método substitutivo possui a vantagem de associar a detecção do amplo espectro de pirogênios do teste in vivo com a sensibilidade do LAL, podendo também ser utilizado para amostras ambientais como ar e poeira[17]. Os resultados indicaram que somente quatro produtos são preconizados nas três farmacopeias simultaneamente quanto à exigência de se testar a contaminação pirogênica (Tabela 1). Quando o total de monografias dos produtos injetáveis foi contabilizado por farmacopeia, observou-se que os testes de Pirogênios e LAL são preconizados para 639 produtos na FA, 194 na FE e 69 na FB. Dos 69 produtos injetáveis que passam por testes de pirogenicidade, 41 fazem exclusivamente o LAL e 28, o Teste de Pirogênios. No caso das 28 monografias preconizadas para o Teste de Pirogênios, nove são medicamentos, sendo que destes somente três fazem exclusivamente o Teste de Pirogênios, representando 33% destes produtos (Arteméter, Cloridrato de Metoclopramida e Flunitrazepam). Monografias que possuem testes para a detecção de pirogênios nas três farmacopeias
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