Dissolution Enhancement of Danazol Nanoparticles prepared by Nanoprecipitation Method

Abstract

Danazol is a weak androgenic steroid taking by mouth and it’s practically insoluble in water. This study was accomplished to prepare danazol nanosuspension by nanoprecipitation method at a diverse (polymer to drug) ratio of 0.5:1, 1:1, 2:1 and 3:1 utilizing Hydroxypropyl methylcellulose (HPMC) -A4C, HPMC-E50 and Polyvinylpyrrolidone (PVP) K-15 as stabilizers. The particle size of the organized formulas was in the nano-sized and the finest formula was F12 at a polymer to drug ratio of 0.5:1 which gave the littlest particle size of ( 33nm). The investigations of drug–stabilizer compatibility were studied by Fourier transform infrared (FTIR) spectroscopy and Differential scanning calorimetry (DSC), crystalline state by XRD, size, and figure/ shape of nanoparticles by Field Emission Scanning Electron Microscopy (FESEM) and the results revealed that there was no interaction between the danazol and stabilizer and there was the partial translation of danazol from crystalline to an amorphous state . The loading efficiency was (91.2% ± 0.4) in the (F12). The simple capsule was set of F12 and the filler was lactose and the in vitro dissolution study was accompanied consuming 0.1N HCl (pH 1.2) with 2% w/v Brij-35, phosphate buffer solution (pH 6.8) with 2% w/v Brij-35 as dissolution media. 100% of the danazol was released from the nanoparticle capsule in both dissolution media within 30 minutes, Whereas , the raw and physical blend capsules as controls were nearly complete in 120 minutes. In conclusion , nanoprecipitation method is an easy, effective method to make danazol nanoparticles with a more rapidly in vitro dissolution rate than raw drug and its physical mixture with stabilizer.