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Abstract(s)
Grande parte dos sistemas de embalagem, entrega, administração e processamento dos
produtos farmacêuticos, alimentares e cosméticos, são feitos a partir de materiais plásticos,
como elastómeros e polímeros, podendo ainda ser adicionados aditivos químicos. Estes
sistemas, necessitam de ser adequados ao uso pretendido e devem apresentar certos
atributos, tais como ter a capacidade de proteger e ao mesmo tempo serem compatíveis com
o produto farmacêutico, alimentar ou cosmético.1
De forma a comprovar a compatibilidade destes sistemas, são realizados estudos de extraíveis
e lixiviáveis. Estão disponíveis diferentes Normas Internacionais e protocolos, para a
realização destes estudos e apesar de existirem diferenças entre estudos de extraíveis em
embalagens de produtos farmacêuticos e estudos de embalagens em contacto com os
alimentos, a estratégia de avaliação é comum e tem em consideração três fases do estudo: a
primeira fase tem como objetivo reunir informações atualizadas do fornecedor, sobre a
composição dos materiais plásticos e das suas especificações de controlo de qualidade; a
segunda fase consiste na avaliação da migração global; a terceira fase baseia-se na avaliação
dos extraíveis, ou seja, é realizada uma migração específica com o intuito de identificar os
extraíveis e avaliar os seus potenciais riscos. Estes são avaliados recorrendo a processos de
extração agressivos e a métodos de identificação com base em múltiplas metodologias
analíticas. Caso os compostos observados estejam acima do limite de segurança, é necessário
recorrer à identificação e avaliação da toxicidade e é necessário realçar que, para muitos
aditivos não existem dados toxicológicos.2
Quando se realiza pela primeira vez um estudo sobre os extraíveis, pode-se ter uma ideia
limitada do que procurar e quais as técnicas de extração e os métodos analíticos que devem
ser usados para a identificação e avaliação de possíveis lixiviáveis.3 Assim, com a realização
deste projeto pretende-se implementar ensaios otimizados e validados para estudos de
extração e de lixiviação.
Much of the packaging, delivery, administration and processing systems for pharmaceuticals, food and cosmetics are made from plastic materials, as elastomers and polymers, and may also present chemical additives. These systems need to be suitable for the intended use and should have certain attributes, such as being able to protect and at the same time being compatible with the pharmaceutical, food or cosmetic product.1 In order to prove the compatibility of these systems, extractable and leachable studies are carried out. Different International Standards and protocols are available to carry out these studies and even though, there are differences in the studies of extractables in packages of pharmaceuticals with the packages in contact with food, the evaluation strategy is common and takes into account three phases of the study: the first phase aims at gathering the most updated information from the provider, on the composition of the plastic materials and its quality control specifications. The second aim consists in the evaluation of the overall migration. The third aim is based on the evaluating of extractables, that is, a specific migration is performed in order to identify extractables and evaluate their potential risks. These are evaluated using aggressive extraction process and multiple analytical methodologies. If the compounds are present above the safety limit, identification and toxicity evaluation is necessary, and it should be highlight that for several additives there is no toxicological data available. 2 When a study on extractables is carried out for the first time, one can have a limited idea of what to look for and which extraction techniques and analytical methods should be used for the identification and evaluation of possible leachables.3 Thus, with the accomplishment of this project we intend to implement optimized and validated tests for extraction and leaching studies.
Much of the packaging, delivery, administration and processing systems for pharmaceuticals, food and cosmetics are made from plastic materials, as elastomers and polymers, and may also present chemical additives. These systems need to be suitable for the intended use and should have certain attributes, such as being able to protect and at the same time being compatible with the pharmaceutical, food or cosmetic product.1 In order to prove the compatibility of these systems, extractable and leachable studies are carried out. Different International Standards and protocols are available to carry out these studies and even though, there are differences in the studies of extractables in packages of pharmaceuticals with the packages in contact with food, the evaluation strategy is common and takes into account three phases of the study: the first phase aims at gathering the most updated information from the provider, on the composition of the plastic materials and its quality control specifications. The second aim consists in the evaluation of the overall migration. The third aim is based on the evaluating of extractables, that is, a specific migration is performed in order to identify extractables and evaluate their potential risks. These are evaluated using aggressive extraction process and multiple analytical methodologies. If the compounds are present above the safety limit, identification and toxicity evaluation is necessary, and it should be highlight that for several additives there is no toxicological data available. 2 When a study on extractables is carried out for the first time, one can have a limited idea of what to look for and which extraction techniques and analytical methods should be used for the identification and evaluation of possible leachables.3 Thus, with the accomplishment of this project we intend to implement optimized and validated tests for extraction and leaching studies.
Description
Keywords
Cromatografia Embalagens Extraíveis Lixiviáveis Migração Global