Structural and vibrational investigations of oxcarbazepine and deflazacort

S. FAUDONE, A.P. AYALA, J. MENDES FILHO, J. ELLENA AND Y.P. MASCARENHAS, V. AIASSA, N. SPERANDEO, S.L. CUFFINI

Villa Giardino. Córdoba

Otro; IX Sem. Latinoamericano de Analisis por Técnicas de Rayos X; 2004

Active pharmaceutical ingredients (APIS) are frecuently administered to patients in the solid state as part of an approved solid oral dosage form. However, many pharmaceutical solids can exist in different solids form (polimorphs, solvates and amorphous form). Polymorphisms may result in differences in physico-chemicals properties of APIS, and variation in this properties can have profound impact on drug product manufacturability, quality and performance, which may render, for example a generic drug product to be bioinequivalent to the innovator brand. For this reason, a number of methods have been employed for characterizing polimorphs. Al present, two of the most powerfull techniques for the structural characterizing polimorphs. At present, two of the most powerfull techniques for the structural characterization of APIS are X-ray diffraction and vibrational spectroscopy, since they give directly precise structural and molecular information. However, both techniques  are not routinely user for the quality control of APIS in the pharmacetical industry. The aim of this presentation is to review the application of the above mentioned methods  for the characterization of the solid state of Oxcarbazepine (OXC) and Deflazacort (DEF). Our results give rise to a precise determination of the crystal structure as well as the vibrational spectra, which may be used as fingerprint for the monitoring and the quality control of these sustances.