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Publication
Caracterização física das formas farmacêuticas sólidas
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Advisor(s)
Abstract(s)
A maioria dos produtos farmacêuticos comercializados é-o sob a forma de formas
farmacêuticas sólidas. A escolha de uma formulação ideal prende-se com o facto de o
medicamento ter de cumprir todos os pressupostos regulamentares inscritos nas
farmacopeias, tanto para a substância ativa como para a forma farmacêutica em causa,
sendo que também deve atingir o, ou os objetivos terapêuticos e por fim atingir elevados
níveis produtivos.
A melhoria nas propriedades físicas (solubilidade, tamanho das partículas, polimorfismo
p.ex.) das formas farmacêuticas sólidas, quer ao nível dos excipientes ou fármacos
exercem bastante influência na qualidade do medicamento final, bem como no menor
custo de produção do mesmo, pelo facto de o produto final ser afetado pelas
propriedades das formas farmacêuticas sólidas.
Esta monografia tem como objetivo a revisão das técnicas disponíveis para o estudo das
propriedades físicas das formas farmacêuticas sólidas, bem como a caracterização das
formas farmacêuticas sólidas e a sua relação com os perfis de dissolução ao nível da
farmacocinética.
It is evident that the majority of marketed pharmaceuticals are in the form of solid dosage forms. The choice of an optimal formulation is related to the fact that the medicine has to meet all the conditions listed in pharmacopoeia regulations, both for the active substance and to pharmaceutical form in question, and must also achieve the therapeutic purposes and/or finally achieve high production levels. The improvement of physical properties (solubility, particle size or polymorphism) of solid dosage forms, either at the level of excipients or active ingredients exerts an important effect on the quality of the final drug and also on production cost. In fact, all the final product is affected by the properties of solid dosage forms. This monograph aims to review the available techniques for the study of the physical properties of solid dosage forms, as well as the characterization of solid dosage forms and their relationship with the dissolution profiles in the pharmacokinetics.
It is evident that the majority of marketed pharmaceuticals are in the form of solid dosage forms. The choice of an optimal formulation is related to the fact that the medicine has to meet all the conditions listed in pharmacopoeia regulations, both for the active substance and to pharmaceutical form in question, and must also achieve the therapeutic purposes and/or finally achieve high production levels. The improvement of physical properties (solubility, particle size or polymorphism) of solid dosage forms, either at the level of excipients or active ingredients exerts an important effect on the quality of the final drug and also on production cost. In fact, all the final product is affected by the properties of solid dosage forms. This monograph aims to review the available techniques for the study of the physical properties of solid dosage forms, as well as the characterization of solid dosage forms and their relationship with the dissolution profiles in the pharmacokinetics.