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Chemical-physical characterization of ingredients and gel formulations for skin application
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A formulação em gel de produtos farmacêuticos para aplicação na pele e mucosas é um dos meios preferenciais de administração de determinadas substâncias ativas, por inúmeras razões e, por isto, é um assunto bastante atual na área da dermofarmácia. No entanto, a incorporação de alguns excipientes nesta forma farmacêutica pode apresentar algumas limitações que poderão ser ultrapassadas através do estudo físico-químico dos ingredientes a incorporar na respetiva formulação. Para além disto, para que a substância ativa possa ser libertada e absorvida a nível local ou sistémico, a propriedade da adesão da formulação em estudo é um fator crucial.
Este trabalho dedica-se ao estudo físico-químico de alguns polímeros e outros ingredientes constituintes de formulações de gel, de forma a sublinhar certas propriedades importantes no desenvolvimento da formulação e na produção do produto. O estudo foi realizado através de duas metodologias: a determinação dos ângulos de contacto dos ingredientes/produtos em estudo com diferentes substratos – vidro, Teflon® e mucina – e a caracterização reológica dos mesmos. Os ingredientes das formulações em gel deste estudo são: Carbopol® 974, Noveon® AA1, OraRez™, Mucosave® e ácido hialurónico (com diferentes pesos moleculares), sendo também avaliados numa segunda fase os valores de quatro produtos comerciais.
Em ambos os ensaios, usando diferentes variáveis, concluiu-se que a concentração de polímeros nas formulações em gel influencia significativamente as propriedades da forma farmacêutica final. Os estudos reológicos permitiram avaliar o impacto da temperatura e da concentração dos diferentes ingredientes na viscoelasticidade do produto. Por outro lado, a determinação dos ângulos de contacto conseguiu mimetizar a interação das formas farmacêuticas com vários substratos inclusive a mucosa e conclui-se que a relação entre o substrato em vidro e os produtos é o mais semelhante à relação que existe entre estes e a mucosa.
The gel formulation of pharmaceutical products for application to the skin and mucosa is one of preferred routes of administration of certain active substances, for several reasons and, therefore, a very current issue in the field of dermatology investigation. However, the incorporation of some excipients presents some limitations that could be overcome by the physico-chemical study of the constituents to be incorporated into these formulations. Besides this, so that the active substance could be released and absorbed locally or systemically, the adhesion properties of the studied formulations plays a crucial role. The aim of this work is the physico-chemical study of some polymers and other constituent ingredients gel formulations in order to highlight certain important properties for the formulation and production of the products. The study was performed using two different techniques: measuring the contact angles of the ingredients/products with different substrates - glass, Teflon® and mucin - and measuring and evaluating the rheological properties of these same ingredients/products. The gel formulation ingredients’ used were Carbopol® 974, Noveon® AA1, OraRez™, Mucosave® and hyaluronic acid (with different molecular weights). In both assays, using different variables, it can be concluded that the amount of polymer does modify the properties of the final pharmaceutical form meaningfully. With the rheological assessment, it was possible to verify the impact of temperature and concentration of the different ingredients in the viscoelasticity of the product. On the other hand, contact angles determination allowed to mimic the interaction of the dosage forms with the mucosa and it can be concluded that the glass substrate is the most similar to the mucosa.
The gel formulation of pharmaceutical products for application to the skin and mucosa is one of preferred routes of administration of certain active substances, for several reasons and, therefore, a very current issue in the field of dermatology investigation. However, the incorporation of some excipients presents some limitations that could be overcome by the physico-chemical study of the constituents to be incorporated into these formulations. Besides this, so that the active substance could be released and absorbed locally or systemically, the adhesion properties of the studied formulations plays a crucial role. The aim of this work is the physico-chemical study of some polymers and other constituent ingredients gel formulations in order to highlight certain important properties for the formulation and production of the products. The study was performed using two different techniques: measuring the contact angles of the ingredients/products with different substrates - glass, Teflon® and mucin - and measuring and evaluating the rheological properties of these same ingredients/products. The gel formulation ingredients’ used were Carbopol® 974, Noveon® AA1, OraRez™, Mucosave® and hyaluronic acid (with different molecular weights). In both assays, using different variables, it can be concluded that the amount of polymer does modify the properties of the final pharmaceutical form meaningfully. With the rheological assessment, it was possible to verify the impact of temperature and concentration of the different ingredients in the viscoelasticity of the product. On the other hand, contact angles determination allowed to mimic the interaction of the dosage forms with the mucosa and it can be concluded that the glass substrate is the most similar to the mucosa.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2016
Palavras-chave
Mucoadesão Mucosa Polímeros Gel Carbopol® 974 Noveon® AA1 OraRez™ Mucosave® Ácido Hialurónico Mestrado Integrado - 2016