Dissolution composition for examining drug solubility

摘要

There are described solid compositions or examining drug solubility comprising bile salts and phospholipids, optionally containing buffer components suitable for preparation of intestinal media that simulate the composition of the intestinal fluids in fasted and fed states.

主权项

1. A method of determining solubility or dissolution of a pharmacological compound, comprising:
preparing an aqueous medium containing at least one buffer component and at least one osmotic agent; adding a homogeneous solid dissolution composition in a granular or powder form comprising at least one bile salt and at least one phospholipid to the aqueous medium to form a simulated gastrointestinal medium; adding at least one of a pharmacological compound, a physiological compound and a dosage form to the simulated gastrointestinal medium to determine a solubility or dissolution characteristic of the pharmacological compound, physiological compound or dosage form.