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Tablet Subdivision: Assessment of compliance with regulatory requirements of medicines marketed in Portugal
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Resumo Introdução e Objetivos: O objetivo deste estudo foi determinar se os comprimidos com ranhura de divisão, comercializados em Portugal, apresentam uma quebra deficiente e se tal se constitui um obstáculo, nomeadamente para a população idosa. Outro objetivo foi avaliar a conformidade deste tipo de comprimidos com os requisitos regulamentares e identificar possíveis incoerências relacionadas com a rotulagem. Métodos: Foi realizado um estudo com 47 voluntários, de modo a avaliar se a perda de massa durante a subdivisão de comprimidos é significativa e para quantificar a facilidade de quebra de comprimidos para os utentes. Foram incluídos comprimidos “padrão” em cada conjunto dado aos voluntários. Esperava-se que os utentes manifestassem o grau de dificuldade de quebra de modo a ser detetada a quota parte atribuivel a cada utente em si. Antes dos conjuntos serem cedidos aos utentes foram avaliados em laboratório em termos de uniformidade da massa, bem como da resistência ao esmagamento (dureza dos comprimidos) e as dimensões dos mesmos. Esperava-se que estes testes apresentassem resultados relativamente ao desvio de massa e que os mesmos, em conjunto com as características dos comprimidos ajudassem a prever o comportamento dos mesmos no estudo com os voluntários. Resultados: Em cerca de 10% das observações verificou-se a incapacidade dos voluntários em quebrar os comprimidos ou a sua fragmentação em mais do que as duas metades esperadas. Em cerca de metade das avaliações os utentes classificaram os comprimidos como muito fáceis de quebrar. No entanto, num quinto das observações os utentes avaliaram os comprimidos como difíceis ou muito difíceis de quebrar, bem como os casos em que o utente não conseguiu partir o comprimido. Conclusão: A implementação de requisitos regulamentares é de extrema importância, pois critérios mais rigorosos permitirão um menor número de não conformidades e, portanto, maior segurança para o utente em relação ao uso de comprimidos com ranhura de quebra. O uso de modelos de previsão pode ser um recurso útil que permita determinar quais os parâmetros físicos e farmacotécnicos que devem ser otimizados de modo a ser obtida uma subdivisão mais precisa e adequada de comprimidos ranhurados.
Introduction & Aims: The aim of this project was to determine if the tablets bearing a break or score line, marketed in Portugal, present inaccurate subdivision, especially regarding the elderly population. Another aim was to assess the compliance with regulatory requirements of such products, and to target possible issues regarding labelling. Methods: A study comprehending 47 volunteers was performed, to evaluate if mass loss during tablet subdivision is significant and to quantify the ease of subdivision of tablets for the patients. Standard tablets that would be considered either too hard or two easy to break were included in each set given to the volunteers, in order to detect possible patient-related issues. Previously to this study, the mass uniformity of the provided tablets was assessed, as well as the resistance to crushing (tablet hardness) and measurements of the tablets. It was expected that assessments presented mass deviation results and tablet characteristics that would help to predict the behavior of the tablets in the study with the volunteers, as well as an established prediction model. Results: About 10% of the observations reflect either the inability of the volunteers to break the tablets or the splitting of tablets in more fragments than the two expected halves. Around half of the observations correspond to situations in which the patients classified the tablets as very easy to break. However a fifth of the observations represent situations where the patients found the tablets hard or very hard to break as well as cases where the patient was not able to break the tablet. Conclusion: Implementation of regulatory requirements have a particular importance since more strict criteria would allow less non conformities, and therefore more safety for the patient regarding the use of scored tablets. The use of prediction models can be used as an asset in order to determine which tablet physical and pharmacotechnic parameters should be optimized for an enhanced and accurate tablet subdivision.
Introduction & Aims: The aim of this project was to determine if the tablets bearing a break or score line, marketed in Portugal, present inaccurate subdivision, especially regarding the elderly population. Another aim was to assess the compliance with regulatory requirements of such products, and to target possible issues regarding labelling. Methods: A study comprehending 47 volunteers was performed, to evaluate if mass loss during tablet subdivision is significant and to quantify the ease of subdivision of tablets for the patients. Standard tablets that would be considered either too hard or two easy to break were included in each set given to the volunteers, in order to detect possible patient-related issues. Previously to this study, the mass uniformity of the provided tablets was assessed, as well as the resistance to crushing (tablet hardness) and measurements of the tablets. It was expected that assessments presented mass deviation results and tablet characteristics that would help to predict the behavior of the tablets in the study with the volunteers, as well as an established prediction model. Results: About 10% of the observations reflect either the inability of the volunteers to break the tablets or the splitting of tablets in more fragments than the two expected halves. Around half of the observations correspond to situations in which the patients classified the tablets as very easy to break. However a fifth of the observations represent situations where the patients found the tablets hard or very hard to break as well as cases where the patient was not able to break the tablet. Conclusion: Implementation of regulatory requirements have a particular importance since more strict criteria would allow less non conformities, and therefore more safety for the patient regarding the use of scored tablets. The use of prediction models can be used as an asset in order to determine which tablet physical and pharmacotechnic parameters should be optimized for an enhanced and accurate tablet subdivision.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2019
Palavras-chave
Divisão de comprimidos Comprimidos com ranhura Facilidade de quebra Divisibilidade de comprimidos Aspetos regulamentares. Mestrado Integrado - 2019