Quality by design e gerenciamento de riscos como estratégias para a construção de um modelo regulatório para medicamentos de base nanotecnológica
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Data
2017-05-12
Autores
Dias, André Luís [UNESP]
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
A nanotecnologia tem evoluído rapidamente em diversas áreas, incluindo na área farmacêutica. Para produtos sujeitos à regulação sanitária, em especial medicamentos, esta evolução é um desafio regulatório. Embora já existam medicamentos base nanotecnológica disponíveis no mercado, existem importantes lacunas regulatórias que precisam ser preenchidas. Assim, frente à importância e ao impacto deste tema, foi realizada uma pesquisa científica-regulatória de modo a propor bases para a construção de um arcabouço regulatório, em especial para a regulação de medicamentos de base nanotecnológica. Ficou evidente que não existe, a nível mundial, diretrizes únicas para este tipo de regulação, iniciando pela ausência de consenso no conceito de “nanomaterial”. Percebe-se como consenso internacional que a complexidade e diversidade que cerca os nanomateriais exigem abordagens diferenciadas daquelas empregadas em produtos tradicionais, requerendo avaliações caso a caso e abordagens para avaliar os novos riscos introduzidos. Dessa forma, este trabalho avaliou as metodologias Quality by Design (QbD) e Gerenciamento de Riscos como alternativas para a construção do modelo regulatório. QbD e Gerenciamento de Riscos facilitam, compilam, direcionam e sistematizam o conhecimento e assim, por meio do desenvolvimento de produtos robustos, seguindo as etapas previstas no QbD, inclusive com a construção e sedimentação do Perfil de Qualidade Alvo do Produto e de Atributos Críticos a Qualidade, constituem importantes instrumentos para a construção da qualidade em medicamentos de base nanotecnológica. O Gerenciamento de Riscos, em especial a análise de risco, permite a categorização dos nanomateriais em cinco níveis de riscos, identificados a partir de um algoritmo construído por meio de aspectos técnicos, tornando as atividades regulatórias mais direcionadas para os produtos que oferecem maior risco. QbD e análise de riscos foram utilizados em um estudo de caso, aplicado nas etapas do desenvolvimento da doxorrubicina lipossomal peguilada – Doxil®, o primeiro e um dos principais medicamentos de base nanotecnológica disponível no mercado. As metodologias QbD e Gerenciamento de Riscos apresentadas, direcionadas e discutidas são capazes de responder às demandas regulatórias tornando-se, assim, pilares para a construção de um modelo regulatório.
Nanotechnology has evolved rapidly in diverse areas, which include the pharmaceutical field. For products subject to sanitary regulation, especially drugs, this evolution is a regulatory challenge. Although there are nanotechnological drugs available in the market, there are important regulatory gaps that must be completed. Thus, in view of the importance and impact of the object, a scientific-regulatory research was carried out in order to propose bases for a regulatory framework, particularly for a regulation of nanotechnological drugs. It became clear that there is no a worldwide guidance for this type of regulation, starting with the lack of consensus for the concept of "nanomaterial". It has been noticed as an international consensus that the complexity and diversity surrounding nanomaterials require different approaches from those used in traditional products, demanding case-by-case evaluation and approaches to assess new introduced risks. Thus, this work evaluated Quality by Design (QbD) and Risk Management methodologies as alternatives for the construction of the regulatory model. QbD and Risk Management facilitate, compile, direct and systematize knowledge and thus, through a robust product development, following as expected by QbD steps - including a construction and sedimentation of the Product Target Quality Profile and Critical Quality Attributes - become important tools for building quality in nanotechnology-based drugs. Risk Management, especially the risk analysis, allows the categorization of the nanomaterials into five levels of risks, identified from an algorithm constructed through cientific aspects, making the regulatory activities more targeted to the greater risk products. QbD and risk analysis tools were used on a case study, applied in the development stages of pegylated liposomal doxorubicin - Doxil®, the first and one of the main nanotechnology-based drugs available in the market. The QbD and risk management methodologies that have been presented, addressed and discussed are capable of responding to the regulatory demands, becoming pillars for the construction of a regulatory framework.
Nanotechnology has evolved rapidly in diverse areas, which include the pharmaceutical field. For products subject to sanitary regulation, especially drugs, this evolution is a regulatory challenge. Although there are nanotechnological drugs available in the market, there are important regulatory gaps that must be completed. Thus, in view of the importance and impact of the object, a scientific-regulatory research was carried out in order to propose bases for a regulatory framework, particularly for a regulation of nanotechnological drugs. It became clear that there is no a worldwide guidance for this type of regulation, starting with the lack of consensus for the concept of "nanomaterial". It has been noticed as an international consensus that the complexity and diversity surrounding nanomaterials require different approaches from those used in traditional products, demanding case-by-case evaluation and approaches to assess new introduced risks. Thus, this work evaluated Quality by Design (QbD) and Risk Management methodologies as alternatives for the construction of the regulatory model. QbD and Risk Management facilitate, compile, direct and systematize knowledge and thus, through a robust product development, following as expected by QbD steps - including a construction and sedimentation of the Product Target Quality Profile and Critical Quality Attributes - become important tools for building quality in nanotechnology-based drugs. Risk Management, especially the risk analysis, allows the categorization of the nanomaterials into five levels of risks, identified from an algorithm constructed through cientific aspects, making the regulatory activities more targeted to the greater risk products. QbD and risk analysis tools were used on a case study, applied in the development stages of pegylated liposomal doxorubicin - Doxil®, the first and one of the main nanotechnology-based drugs available in the market. The QbD and risk management methodologies that have been presented, addressed and discussed are capable of responding to the regulatory demands, becoming pillars for the construction of a regulatory framework.
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Palavras-chave
Nanotecnologia, Medicamento, Regulação, Gerenciamento de Riscos, Quality by Design (QbD)