Rapid dissolving high potency danazol powders produced by spray freezing into liquid process

The objective of this study was to investigate the use of organic solvents in the spray freezing into liquid (SFL) particle engineering process to make rapid dissolving high potency danazol powders and to examine their particle size, surface area and dissolution rate. The maximum drug potency produced was 91% for SFL micronized danazol/PVP K-15. XRD indicated that danazol in the high potency SFL powders was amorphous. SEM micrographs revealed that the SFL danazol/PVP K-15 nanostructured aggregates had a porous morphology and were composed of many smooth primary nanoparticles with a diameter of about 100 nm. Surface areas of SFL danazol/PVP K-15 high potency powders were in the range of 28-115 m2/g. The SFL powders exhibited significantly enhanced dissolution rates. The rate of dissolution of micronized bulk danazol was slow; only 30% of the danazol was dissolved in 2 min. However, 95% of danazol was dissolved in only 2 min for the SFL high potency powders. The SFL process offers a highly effective approach to produce high potency danazol nanoparticles contained in larger structured aggregates with rapid dissolution rates, and is especially applicable to delivery systems containing poorly water soluble drugs.