Loading...
Publication
Uso da quality-by-design no desenvolvimento de formulações de nanossistemas lipídicos
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| Projeto de pós-graduação_41815 | 2.15 MB | Adobe PDF |
Authors
Advisor(s)
Abstract(s)
A aplicação da abordagem da qualidade pelo design (quality-by-design - QbD) no desenvolvimento farmacêutico tem sido solicitada pelas autoridades reguladoras (Food and Drug Administration – FDA e European Medicines Agency – EMA), devido à possibilidade de simplificação e redução dos custos dos processos de fabrico. Na QbD, os objetivos de cada processo são definidos inicialmente, o que facilita o controlo e análise dos seus riscos, permitindo a obtenção de produtos seguros e de elevada qualidade.
Nas últimas décadas, as investigações na área dos nanossistemas lipídicos, designadamente das nanopartículas de lípidos sólidos (SLN), dos vetores lipídicos nanoestruturados (NLC) e das nanoemulsões (NE) permitiram o desenvolvimento de novas formulações. Muitos investigadores têm aplicado a QbD na otimização dessas formulações, através da análise dos fatores que interferem com a composição e/ou com os métodos de fabrico, que são críticos para os diferentes parâmetros que caracterizam os nanossistemas. Na primeira parte deste trabalho de revisão, apresentam-se os diferentes conceitos da QbD aplicados ao desenvolvimento de formulações baseadas em nanossistemas lipídicos, bem como as suas características e requisitos gerais. De seguida, são apresentados exemplos de estudos publicados nos últimos anos nesta área. Os resultados obtidos a partir da análise desses estudos demonstram que a aplicação da QbD no desenvolvimento de formulações de nanossistemas lipídicos permitiu obter um maior controlo sobre os atributos críticos da qualidade (CQA) e os parâmetros críticos do processo (CPP). Este controlo resultou na obtenção de formulações com tamanhos de partícula reduzidos e uniformes, elevada eficácia de encapsulação (EE) e boa estabilidade.
Foram também identificadas melhorias significativas na reprodutibilidade e na capacidade de otimizar os métodos de fabrico, contribuindo para a redução de custos e aumento da qualidade final dos produtos desenvolvidos. Com base nos estudos analisados, é evidente que o uso da QbD no desenvolvimento de formulações de nanossistemas lipídicos é uma estratégia promissora para enfrentar os desafios atuais da indústria farmacêutica. Esta abordagem facilita a identificação e minimização dos riscos associados à produção, além de permitir a adaptação eficiente às exigências regulatórias.
The use of the quality-by-design (QbD) approach in pharmaceutical development has been requested by regulatory authorities (Food and Drug Administration – FDA and European Medicines Agency – EMA) due to its potential to simplify and reduce manufacturing costs. In QbD, the objectives of each process are defined from the beginning, facilitating risk control and analysis and enabling the production of safe and high-quality pharmaceutical products. Over the past decades, research in the field of lipidbased nanocarriers, namely solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC), and nanoemulsions (NE), has driven the development of new formulations. Many researchers have applied the QbD principles to optimize these formulations by analyzing factors that influence composition and/or manufacturing methods, which are critical to the various parameters characterizing nanocarriers. The first part of this review work presents the different QbD concepts applied to the development of formulations based on lipid nanosystems, as well as their characteristics and general requirements. Subsequently, are presented examples from studies published in recent years in this field. The results obtained from the bibliographic analysis demonstrated that the application of QbD in lipid nanosystem formulations enabled greater control over critical quality attributes (CQA) and critical process parameters (CPP). This control resulted in the production of formulations with reduced particle sizes, high encapsulation efficiency, and good stability. Significant improvements were also identified in reproducibility and the ability to optimize manufacturing methods, contributing to cost reduction and an overall increase in the quality of the final developed products. Based on the results of these studies, it is evident that the application of the QbD in the development of lipid nanosystem formulations is a promising strategy to address the current challenges of the pharmaceutical industry. This approach facilitates the identification and minimization of risks associated with production while enabling efficient adaptation to regulatory requirements.
The use of the quality-by-design (QbD) approach in pharmaceutical development has been requested by regulatory authorities (Food and Drug Administration – FDA and European Medicines Agency – EMA) due to its potential to simplify and reduce manufacturing costs. In QbD, the objectives of each process are defined from the beginning, facilitating risk control and analysis and enabling the production of safe and high-quality pharmaceutical products. Over the past decades, research in the field of lipidbased nanocarriers, namely solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC), and nanoemulsions (NE), has driven the development of new formulations. Many researchers have applied the QbD principles to optimize these formulations by analyzing factors that influence composition and/or manufacturing methods, which are critical to the various parameters characterizing nanocarriers. The first part of this review work presents the different QbD concepts applied to the development of formulations based on lipid nanosystems, as well as their characteristics and general requirements. Subsequently, are presented examples from studies published in recent years in this field. The results obtained from the bibliographic analysis demonstrated that the application of QbD in lipid nanosystem formulations enabled greater control over critical quality attributes (CQA) and critical process parameters (CPP). This control resulted in the production of formulations with reduced particle sizes, high encapsulation efficiency, and good stability. Significant improvements were also identified in reproducibility and the ability to optimize manufacturing methods, contributing to cost reduction and an overall increase in the quality of the final developed products. Based on the results of these studies, it is evident that the application of the QbD in the development of lipid nanosystem formulations is a promising strategy to address the current challenges of the pharmaceutical industry. This approach facilitates the identification and minimization of risks associated with production while enabling efficient adaptation to regulatory requirements.
Description
Keywords
Quality-by-design Nanossistemas lipídicos Desenvolvimento farmacêutico Lipid nanosystems Pharmaceutical development