Avaliação do impacto de diferentes variáveis no ensaio de dissolução intrínseca de metronidazol

Abstract

ISSA, M. G. Evaluation of the impact of different variables in the intrinsic dissolution test for metronidazole. 2011. 78p. Dissertacao (Mestrado) – Faculdade de Ciencias Farmaceuticas, Universidade de Sao Paulo, Sao Paulo, 2011. The purpose of this study is to evaluate the impact of different variables in the intrinsic dissolution test of metronidazol. Initially, the samples, with different levels of micronization, underwent physicochemical characterization, whereby they were tested for solubility, particle size, thermal analysis (DSC/TG), Fourier transform infrared (FTIR) spectroscopy, X-ray diffractometry (DRX), surface area analysis by the BET method, optical microscopy, true density and tapped density. Then, intrinsic dissolution tests were carried out according to fractional factorial experimental planning, with each factor being evaluated on three levels. The Statistica 8.0 software program was used for design, and the factors studied were: rotational velocity, pressure used in the formation of the compressed drug, dissolution medium and level of micronization. The results indicated alterations in the rheological properties of the material, as the level of micronization increased, while the remaining properties were unaffected. Among the factors studied in the design, the rotation speed and the dissolution medium were the factors that exercised the most significant influence on the intrinsic dissolution of metronidazol. Although the solubility of the drug is not influenced by particle size, higher values were observed in HCl 0.1 M, the medium in which the highest intrinsic dissolution rates (IDRs) were also obtained.