Obtenção tecnológica de comprimido revestido dose-fixa-combinada à base de Zidovudina, Lamivudina e Efavirenz

AUTOR(ES)
DATA DE PUBLICAÇÃO

2009

RESUMO

The access of infected patients to anti-retroviral therapy is a priority for global public health in developing countries. A large amount of drugs already available for the treatment of AIDS, makes possible new therapeutic associations, which provides a wide adherence to treatment, reducing the mortality rate of infected patients. For this purpose, it has developed anti-retrovirals in combined-fixed-dose. This type of association provides a wide adherence to treatment when compared to administration of the drugs separately. This work aimed to study the stability of drugs zidovudine, lamivudine and efavirenz on acid and basic conditions, as well as physical-chemical characterization of these drugs and the development of coated tablet form as combined-fixed-dose. Was also developed and validated an analytical method of determination by high performance liquid chromatography (HPLC) able to quantify the three drugs in the pharmaceutical form simultaneously. The raw materials of the three drugs had an adequate quality and the developed and validated analytical method showed satisfactory results for all items evaluated. In view of the results achieved, we can ensure the preparation of the pharmaceutical form coated tablet of zidovudine, lamivudine and efavirenz, on combined fixed-dose with proven quality and reliability, the key requirements in developing a product under Good Manufacturing Practices and Control (GMPC), recommended by the regulatory body (ANVISA-MS)

ASSUNTO(S)

validação estabilidade validation farmacia stability método analítico anti-retroviral combined-fixed-dose analytical method dose-fixa-combinada comprimidos tablets anti-retroviral

ACESSO AO ARTIGO

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