Dual Level Statistical Investigation of Equilibrium Solubility in Simulated Fasted and Fed Intestinal Fluid.

摘要: The oral route is the preferred option for drug administration but contains inherent issue of absorption from gastro-intestinal tract (GIT) in order to elicit systemic activity. A prerequisite dissolution, which dependent upon solubility variable milieu GIT fluid, with poorly soluble drugs presenting a formulation and biopharmaceutical challenge. Multiple factors within fluid influence ranging pH concentration ratio amphiphilic substances, such as phospholipid, bile salt, monoglyceride, cholesterol. To aid vitro investigation simulated intestinal fluids (SIF) covering fasted fed state have been developed. SIF media complex statistical design experiment (DoE) investigations revealed range values possible each due physiological variability along factor interactions solubility. However, these studies require large nu...