Tecnologia de obtenÃÃo de anti-retroviral à base de Mesilato de Nelfinavir

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

The Protease Inhibitors (PI) constitutes a powerful class of anti-retroviral drugs that changed the therapy and evolution of the infection by HIV. In March of 1997, a new drug of this class, the Nelfinavir Mesylate was approved by the Food and Drug Administration (FDA). Since then, it has been often used, separately or in association with Reverse Transcriptase Inhibitors (RTIs), achieving considerable clinical effectiveness in the treatment of AIDS. The Nelfinavir Mesylate has the Viracept as reference product in the market, manufactured by Roche industry. This medication is part of the anti-AIDS cocktail distributed in Brazil, being used by 25% of the patients. This work has as main objective present the pharmaceutical and industrial development of a coated tablet with 250mg of Nelfinavir Mesylate, based in a qualitative and quantitative planning of excipientes, and carry out series of bench tests, trying to reach a pharmaceutical form with quality and low cost. Therefore, the raw materials were characterized aiming the qualification of suppliers and the dissolution methodology for the achieved tablets was developed. Besides that, a comparative study of its profile of dissolution versus the reference medicine was also carried out. The work also contemplated the development and the validation of the dosage methodology of the raw material and the final product, using the High Precision Liquid Chromatography (HPLC), following the parameters established by the National Agency of Sanitary Surveillance (ANVISA), in its resolution RE n 899, published in June, 02nd, 2003. Also a comparative study was carried between the reference product, Viracept and the developed product Nelfinavir Mesylate LAFEPEÂ. The coated tablets of the developed Nelfinavir Mesylate had presented good quality and the comparisons made between these and the Viracept had not presented significant differences. The stability studies, accelerated and long term models, are still in progress. This work was accomplished in a partnership between the Center for Quality Control of the Medicines and the Laboratory of Medicines Technology, both from the Departament of Pharmacy of the Federal University of Pernambuco (UFPE) and the Pernambuco State Pharmaceutical Laboratory (LAFEPE)

ASSUNTO(S)

aids comprimidos aids mesilato de nelfinavir farmacia nelfinavir mesylate tablets

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