Estudos de correlaÃÃo de parÃmetros tÃrmicos e de dissoluÃÃo do fluconazol na caracterizaÃÃo tecnolÃgica de desintegrantes

AUTOR(ES)
DATA DE PUBLICAÇÃO

2008

RESUMO

The real need to develop, to produce and to market drugs with high quality level, allied the diversity of products pharmaceutical resultant of different synthesis and purification processes, do one of the improvement of the control of quality of the raw materials of the great challenges of the pharmaceutical industries. The present work studies the correlation of analytical techniques aiming at the attainment of parameters of technological quality of the active raw material fluconazole in relation to the excipients of different manufacturers. The active raw material and binary mixtures have been analyzed through the thermal techniques (TG, DTA, DSC and photovisual DSC), pyrolysis/GC-MS and dissolution. The fluconazole was recrystallizated in methanol, acetone and chloroform obtained three different crystals that were analyzed by DSC-50, DSC-60, photovisual DSC and Pyr/GC-MS. The results obtained showed that raw material presents polymorphs forms when submitted the recrystallization processes for solvent or when submitted to the temperature. The data showed that technical photovisual DSC was capable to characterize besides the processes of melting, the process of volatilization of the fluconazole drug, confirming the thermogravimetrics, where only stage of mass loss was observed, corresponding the volatilization of the drug. The thermogravimetric curves of the mixtures evidenced that the excipients no influence in the process of loss of mass of the drug. The pyrolysis data showed that the fluconazole in the temperature of 250ÂC suffers a volatilization process in its complete molecular form, and that in the temperatures of pyrolysis 500ÂC and 750ÂC degrades in the gas form. The pyrolysis data still evidenced the presence of the hexaclorobenzeno, result of solvent residue or contamination. The studies of the parameters of intrinsic dissolution of FLU defined the best experimental condition for the assay. The vapor pressures weighed of Ac-Di-SolÂ, Solutab and Dissocel mixtures presented larger values than the one of the isolated drug, but when analyzed by the parameters f1 and f2 the results they presented no significant statistical differences. The correlation of the kinetic parameters, vapor pressure and dissolution allowed to demonstrate the smallest interaction of the fluconazole with the croscarmellose SolutabÂ, followed by Ac-Di-Sol and Dissolcel evidenced to agree of a robust analytic technology for physical characterization of the quality of pharmaceutical excipients

ASSUNTO(S)

dissoluÃÃo anÃlise tÃrmica dissolution farmacia fluconazol correlaÃÃo thermal analysis fluconazole correlation vapor of pressure pressÃo de vapor

ACESSO AO ARTIGO

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