ESTUDOS DA QUALIDADE DE COMPRIMIDOS E CÁPSULAS CONTENDO AMINOFILINA

摘要

Asthma is a chronic inflammatory disease characterized by impairment of the lower airways. Theophylline has been used to treat asthma and their preparation for therapeutic purposes is aminophylline. Aminophylline is a complex of theophylline and ethylenediamine, and the ethylenediamine gives an increase in aqueous solubility of theophylline. Aminophylline is often manipulated in pharmacies as capsules, even if a drug with narrow therapeutic index, which is not recommended for manipulation. A potentiometric determination should be considered in evaluating the assay of ethylenediamine. The content of ethylenediamine in reference drug is showed two times higher compared to other drugs and this may be related to the ideal dissolution profile. Generic drugs presented with the dissolution profile and dissolution efficiency data closest in relation to the reference product, which was expected. However, similar and manipulated drugs shown to be without any control of the drug release compared to the reference drug. The results show that although the requirement of ANVISA, concerning mandatory dissolution profile, the manipulated products are unsatisfactory.