Comparison of the solubility and dissolution of drugs in fasted-state biorelevant media (FaSSIF and FaSSIF-V2)

Abstract

The equilibrium solubility values and dissolution profiles in each of the media (FaSSIF or FaSSIF-V2) produced using methylene chloride and the corresponding SIF Powder are equivalent for the drugs tested representing acid, basic, and neutral compounds. Therefore, it is practical to switch from the more labor-intensive solvent-evaporation method to the use of standardized instant powders for preparing biorelevant media without affecting the solubility and dissolution results. Testing in the two versions of FaSSIF media with different bile salt/lecithin ratios will give an indication on how the drug and formulation could be affected in vivo by the variations in bile salt/lecithin ratio within the range found in human small intestinal fluids.