Fiocruz vai produzir fármaco para isquemia cardíaca
O Instituto de Tecnologia em Fármacos (Farmanguinhos/Fiocruz) vai produzir um importante medicamento para tratamento de isquemia cardíaca, o Vastarel, na concentração 80 mg. Com o objetivo de abastecer o Sistema Único de Saúde (SUS), a fabricação no Complexo Tecnológico de Medicamentos (CTM) será viabilizada a partir de uma parceria entre a unidade da Fiocruz e o laboratório francês Servier. O diferencial deste acordo está na internalização da tecnologia de micropellets, modo de encapsulamento que possibilita liberação diferenciada dos fármacos, prolongando a ação do medicamento. Incorporada, tal tecnologia poderá ser usada, futuramente, para o desenvolvimento de outros medicamentos de interesse do SUS.
Segundo a vice-diretora de Operações e Produção (VDOP), Elda Falqueto, a etapa de transferência começou no mês passado, quando especialistas do Laboratório de Tecnologia Farmacêutica (LTF), da VDOP e do Núcleo de Validação e Qualificação (NVQ) visitaram as instalações da Egis Pharmaceuticals, empresa vinculada ao grupo Servier localizada na Hungria. A planta é especializada neste tipo de produção em micropellets.
Desta forma, durante três dias (6, 7 e 8 de junho), três profissionais de Farmanguinhos, permaneceram na cidade de Körmend absorvendo a tecnologia: Abel Alves Rosa Junior (VDOP), Douglas Andrade (LTF) e Rodrigo Correa (NVQ). “Acompanhamos o processo de produção dos micropellets revestidos de liberação modificada tendo a oportunidade de aprender detalhes deste processo produtivo complexo e detalhado. A absorção desta tecnologia é de grande importância estratégica para Farmanguinhos, uma vez que a capacidade de produção desta forma farmacêutica aumenta as possibilidades de produção e desenvolvimento de novos medicamentos”, avalia o farmacêutico Abel Alves Rosa Junior.
Chefe do Laboratório de Tecnologia Farmacêutica, Juliana Johansson destaca que estes sistemas de micropellets permitem a otimização da biodisponibilidade de diversos princípios ativos ou a modulação do perfil de dissolução das formas farmacêuticas, facilitando a veiculação e absorção delas pelo organismo do paciente.
“No caso específico do Vastarel, o princípio ativo contido nos micropellets apresenta liberação prolongada, fazendo com que esta ocorra de forma lenta e contínua no organismo. Com esta tecnologia, a concentração plasmática se mantém mais estável no paciente, reduzindo a ocorrência de eventuais efeitos colaterais provocados pelo medicamento. Outra vantagem é a redução do número de tomadas diárias do medicamento, já que uma dose maior pode ser entregue lentamente ao longo do tratamento e, consequentemente, o aumento da adesão”, explica Juliana.
Outro benefício apontado pela farmacêutica é a possibilidade de revestir os micropellets com polímeros gastrorresistentes. “Desta forma, permite-se que o princípio ativo seja disponibilizado apenas em porções específicas do trato gastrointestinal do usuário. Esse recurso tecnológico pode ser vantajoso no caso de moléculas que sofrem degradação em pH ácido ou que possuem máximo de absorção em faixas de pH alcalinas”, observa a pesquisadora.
Quanto à parceria em si, Juliana Johansson afirma que o convênio beneficia as duas instituições, assim como todas as demais que envolvem contato entre equipes técnicas de diferentes empresas e com culturas diversas. “Do ponto de vista de Farmanguinhos, mais especificamente, é um grande ganho trabalhar com um parceiro disponível para que o treinamento na nova tecnologia ocorra de maneira transparente e proveitosa. O fato de a Servier abrir as portas para transferir a tecnologia do seu processo de obtenção dos micropellets, que serão encapsulados em Farmanguinhos, proporciona um grande crescimento à nossa equipe”, avalia.
Por Alexandre Matos (Farmanguinhos/Fiocruz)
Fonte: AFN
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