Abstract

STUDYING DISPERSION SYSTEMS OF MICONAZOLE NITRATE WITH MANNITOL AND UREA

*Omar H. El-Garhy

Department of Pharmaceutics, Faculty of Pharmacy, Minia University, Minia, Egypt.

ABSTRACT

  Different dispersion systems of miconazole nitrate (MN) with two water soluble carriers; mannitol and urea, were prepared at drug-carrier ratios; 2:1, 1:1 and 1:2 w/w, using evaporation and melting methods as different dispersion methods. The corresponding physical mixtures of MN with either mannitol or urea were also prepared. Infrared spectroscopy (IRS) and differential scanning calorimetry (DSC) were employed to study the physicochemical properties of different prepared MN-carrier systems. Moreover, in-vitro dissolution studies and microbiologic assay were performed for characterization and evaluation of the dissolution behavior and the antimycotic activity of MN upon its dispersion with mannitol or urea in different systems. The results of DSC demonstrated that MN-carrier dispersion systems that prepared by melting method rather than evaporation method display a greater reduction in the crystallinity of MN. The dissolution behavior of MN from its different prepared dispersion systems with mannitol or urea was markedly improved comparing by that of MN intact. The extent of improvement in MN dissolution profile shown by different prepared MN-carrier dispersion systems was found to be dependent on both the carrier type and the dispersion method used and is increased as a function of the weight fraction of the investigated carrier (mannitol or urea). The MN-urea dispersion systems that prepared by melting method at a drug: carrier ratio 1:2, exhibited better dissolution profile among the other prepared MNcarrier dispersion systems. The microbiologic assay demonstrated that the aqueous solutions of MN-carrier systems showed inhibition zones of larger diameter than that of MN intact. This proved the superiority of the antimycotic activity of MN-carrier systems comparing by that of MN intact.

Keywords: miconazole nitrate, dispersion, mannitol, urea and dissolution behavior.