Início
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Arquivos
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v. 1 n. 1 (2020): Edição Especial: Anais do I Congresso Brasileiro de Ciências Farmacêuticas On-line
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Anais de Evento
AVALIAÇÃO DA QUALIDADE DE COMPRIMIDOS DE ÁCIDO MEFENÂMICO: MEDICAMENTO DE REFERÊNCIA, SIMILAR E GENÉRICO
Autores
Francini Ritiele Rompato Fischer
Faculdade de Ciências Sociais Aplicada – UNIC
Gabriela Bortoli Jahn
Faculdade de Ciências Sociais Aplicada – UNIC
Palavras-chave:
Ácido mefenâmico, Comprimidos. Controle de qualidade, Genérico, Medicamento de referência, Similar intercambiável
Resumo
Introdução: A análise do controle de qualidade nos medicamentos é muito importante para determinar se o produto está em concordância com as exigências da ANVISA junto às especificações farmacopeicas. A escolha do medicamento foi originada por ser um anti-inflamatório e possuir fácil acesso nas drogarias da cidade, principalmente na ausência de receita médica. Objetivo: analisar, relatar e realizar um diagnóstico comparativo entre os três medicamentos ofertados para análise com os métodos gerais assegurados pela farmacopeia brasileira. Material e métodos: Elaborou-se uma pesquisa exploratória no qual foram processados 36 comprimidos de cada amostra de referência, similar e genérico do princípio ativo ácido mefenâmico 500mg, realizados em triplicata os testes de avaliação do aspecto visual, peso médio, dureza, friabilidade e teste de desintegração executados no laboratório da universidade, totalizando 108 comprimidos de cada. Resultados: Na avaliação do aspecto visual somente o genérico apresentou-se íntegro, os outros vieram com amostras partidas ou com partículas que se dissipavam durante o manuseio. No peso médio todas as amostras foram aprovadas, sendo a maior variação de 1,67% do medicamento similar e a farmacopeia permite até 5%. No ensaio de dureza e friabilidade analisados juntos, foi reprovado apenas a amostra do medicamento Ponsdril, pois o mesmo apresentou dois comprimidos que se partiram durante o teste de friabilidade e a farmacopeia não permite nenhuma quebra, lasca, rachadura ou partição de comprimidos ao final do teste de friabilidade, as outras amostras foram aprovadas pois obtiveram perda de 0,35% para o medicamento de referência e 0,45% no genérico, sendo permitido perda máxima de 1,5% após o teste. Para a análise da dureza os valores são apenas informativos, no qual apresentaram a média nos valores de 153,7N no Ponstan, 73,1N no Ponsdril e 145,6N para o genérico. Na desintegração todos os comprimidos se dissolveram completamente em até pouco mais de 16 minutos, sendo menor que o tempo limite estabelecido pela farmacopeia. Conclusão: Foi concluído que é necessário ser realizado todos os ensaios disponíveis na farmacopeia para se determinar a qualidade dos medicamentos oferecidos para a população antes deles serem liberados ao comércio, para serem monitorados constantemente e garantir a qualidade dos medicamentos ofertados.
Como Citar
Rompato Fischer , F. R. ., & Bortoli Jahn, G. . (2020). AVALIAÇÃO DA QUALIDADE DE COMPRIMIDOS DE ÁCIDO MEFENÂMICO: MEDICAMENTO DE REFERÊNCIA, SIMILAR E GENÉRICO. Revista Multidisciplinar Em Saúde , 1 (1), 14. Recuperado de https://editoraime.com.br/revistas/rems/article/view/99
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