Avaliação da Qualidade e Perfil de Dissolução de Cápsulas Manipuladas de Piroxicam
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RESUMO. Diferentes ensaios de controle de qualidade foram realizados com capsulas manipuladas de piroxicam, denominadas formulacoes A, B e C, as quais foram adquiridas no municipio de Florianopolis, SC, Brasil. As tres formulacoes foram aprovadas nos ensaios de peso-medio e desintegracao, entretanto, apresentaram algumas irregularidades nos outros ensaios de controle de qualidade. Modelos comparativos matematicos e estatisticos foram utilizados para caracterizar os perfis de dissolucao das capsulas manipuladas e dos medicamentos de referencia e generico desse farmaco. As formulacoes A, B, C, de referencia e generico apresentaram diferentes eficiencias de dissolucao (25,02; 89,79; 84,07; 105,94; 95,95%, respectivamente). Os fatores de diferenca (f1) e semelhanca (f2), demonstraram que as formulacoes nao podem ser consideradas intercambiaveis com os medicamentos de referencia e generico. Portanto, nao e possivel garantir equivalencia terapeutica entre as capsulas manipuladas e industrializadas deste farmaco. SUMMARY. “Quality Evaluation and Dissolution Profile of Piroxicam Manipulated Capsules”. Different assays of quality control had been carried with manipulated capsules of piroxicam, designed formulations A, B and C, which had been acquired in Florianopolis, SC, Brazil. All formulations had been approved in the assays of medium weight and desintegration, however in the other control assays the same ones had presented irregularly. Mathematical and statistical comparative models had been used to characterize dissolution profiles of the manipulated capsules, reference and generic medicines of this drug. The formulations A, B, C, reference and generic had presented different efficiency of dissolution (25.02, 89.79, 84.07, 105.94, and 95.95%, respectively). The difference (f1) and similarity (f2) factors, had demonstrated that the manipulated capsules of piroxicam can not be considered equals to the reference and generic medicines. Because these results it is not possible guarantee therapeutical equivalence between manipulated and industrialized capsules of this drug.
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