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Children friendly medicines :
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Neste projeto vê-se retratado o desenvolvimento de chupa-chupas isentos de açúcar medicados com ácido cítrico para o alívio da tosse em crianças a partir dos 3 anos, um dos sintomas mais prevalentes entre a população pediátrica. Chupa-chupas medicados, são uma forma farmacêutica que demonstra ser promissora em termos de aceitabilidade por parte das crianças, no sentido em que têm o potencial para garantir flexibilidade de dose, tamanho e aspeto, de modo a colmatar problemas de sub ou sobredosagem, deglutição e palatabilidade. Para dar corpo ao chupa-chupa utilizou-se como excipientes principais uma base comercial – PCCA Sorbitol LollipopTM – e isomalte, quer fundido, quer em forma de xarope, ambos submetidos a uma análise térmica cuidadosa. Estes, foram submetidos a um processo de aquecimento e arrefecimento lento, antes da adição dos restantes excipientes da formulação e da deposição da mistura final nos respetivos moldes. Procedeu-se a uma avaliação da uniformidade e características organoléticas dos diversos chupa-chupas, assim como a estudos de dissolução. Verificou-se que o processo de fabrico e as condições de armazenamento poderão ter afetado as características organoléticas e a estabilidade de certos chupa-chupas. No entanto, de um modo geral, os chupa-chupas apresentaram o aspeto desejado, nomeadamente aqueles cujo excipiente principal utilizado foi o xarope de isomalte, e sabor a mel. Os chupa-chupas que continham isomalte foram os que demonstraram ser mais estáveis e seguros para os doentes pediátricos, considerando a estabilidade e os efeitos laxantes do sorbitol (principal excipiente do PCCA Sorbitol LollipopTM), respetivamente. Para além disso, foram os que revelaram um perfil de dissolução mais longo, proporcionando uma ação local prolongada do ácido cítrico,
TM quando comparados com os chupa-chupas que continham PCCA Sorbitol Lollipop
projeto mostrou a possibilidade de transformar um produto alimentar conhecido e comercializado há décadas, numa forma farmacêutica isenta de açúcar passível de ser utilizada em terapia no tratamento da tosse moderada em doentes pediátricos, como alternativa às previamente aprovadas e disponíveis no mercado.
This project portrays the development of sugar-free medicated lollipops for children from 3 years old containing citric acid for mild cough relief, one of the most prevalent symptoms among the paediatric population. Medicated lollipops are a dosage form that has the potential to be well accepted by children while also offering flexibility in dose, size and appearance to address issues related to under- or overdosing, swallowing, and palatability. To embody the lollipop, it was used a commercial base – PCCA Sorbitol LollipopTM – and isomalt, either melted neat or in syrup form, as the main excipients of the lollipop matrix, both submitted to a careful thermal analysis. These excipients were subjected to a slowly heating and cooling method before addition of the rest of the formulation excipients and pouring the final mixture into the lollipop moulds. The various lollipops were characterized for uniformity, and organoleptic and drug dissolution properties. It was found that the manufacturing process and storage conditions may have affected some lollipops organoleptic features and stability. Nonetheless, the lollipops presented a desirable appearance, particularly those whose main excipient was isomalt syrup, and a honey-like taste. Lollipops made with isomalt proved to be most stable and safer for the paediatric patients, taking into consideration sorbitol’s (main excipient of PCCA Sorbitol LollipopTM) stability and laxative effects, respectively. In addition, these were the ones that revealed a longer release profile, providing an extended local action of citric acid, when compared to PCCA Sorbitol LollipopTM based lollipops. The aim of this work was fulfilled by the use of a product that has been sold and advertised for years as a candy in a way that avoids the side effects of sugar and that may not be used for recreational purposes but therapeutically, in order to deliver drugs to paediatric patients. As such, it was possible to develop an alternative dosage form to those previously approved and available in the market for the treatment of mild cough in paediatric patients.
This project portrays the development of sugar-free medicated lollipops for children from 3 years old containing citric acid for mild cough relief, one of the most prevalent symptoms among the paediatric population. Medicated lollipops are a dosage form that has the potential to be well accepted by children while also offering flexibility in dose, size and appearance to address issues related to under- or overdosing, swallowing, and palatability. To embody the lollipop, it was used a commercial base – PCCA Sorbitol LollipopTM – and isomalt, either melted neat or in syrup form, as the main excipients of the lollipop matrix, both submitted to a careful thermal analysis. These excipients were subjected to a slowly heating and cooling method before addition of the rest of the formulation excipients and pouring the final mixture into the lollipop moulds. The various lollipops were characterized for uniformity, and organoleptic and drug dissolution properties. It was found that the manufacturing process and storage conditions may have affected some lollipops organoleptic features and stability. Nonetheless, the lollipops presented a desirable appearance, particularly those whose main excipient was isomalt syrup, and a honey-like taste. Lollipops made with isomalt proved to be most stable and safer for the paediatric patients, taking into consideration sorbitol’s (main excipient of PCCA Sorbitol LollipopTM) stability and laxative effects, respectively. In addition, these were the ones that revealed a longer release profile, providing an extended local action of citric acid, when compared to PCCA Sorbitol LollipopTM based lollipops. The aim of this work was fulfilled by the use of a product that has been sold and advertised for years as a candy in a way that avoids the side effects of sugar and that may not be used for recreational purposes but therapeutically, in order to deliver drugs to paediatric patients. As such, it was possible to develop an alternative dosage form to those previously approved and available in the market for the treatment of mild cough in paediatric patients.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2022, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Isomalt Medicated lollipops Paediatric population PCCA Sorbitol LollipopTM Mestrado integrado - 2022