BIORELEVANT COMPOSITIONS

摘要

This application relates to a homogeneous biorelevant composition for preparing fasted state biorelevant media having a surface tension between 25 mN/m and 50 mN/m for simulating fasted state gastric and fasted state upper small intestinal fluids of mammalian species, especially humans, dogs, etc. comprising at least one bile salt, eg. sodium taurocholate or sodium taurodeoxycholate; at least one phospholipid, especially 60-99 wt % phosphatidylcholine (PC), enzyme digested diacylphospholipids containing 50-90 wt % of monoacyl-PC; or mixtures thereof; and at least one fatty acid or monovalent salt of the fatty acid, such as sodium oleate. The application also relates to an aqueous biorelevant media composed of surfactants occurring in the gastrointestinal tract of mammals, in particular when prepared from above homogeneous biorelevant composition.

主权项

1. A homogeneous biorelevant composition for preparing fasted state biorelevant media having a surface tension between 25 mN/m and 50 mN/m for simulating fasted state gastric and fasted state upper small intestinal fluids of mammalian species, comprising a plurality of surfactants, comprising:
at least one bile salt; at least one phospholipid selected from the group of phospholipids comprising: between 60% and 99% by weight phosphatidylcholine (PC), partially enzyme digested diacyl phospholipids containing between 50% and 90% by weight monoacyl PC, preferably obtained by back-blending with PC, and mixtures of PC and partially enzyme digested diacyl phospholipids wherein the level of monoacyl PC is between 5% and 80% by weight; and at least one fatty acid or monovalent salt of the fatty acid.