Biorelevant dissolution media
AssigneeJanssen Pharmaceutica NV
InventorsHitesh Jogia, Bhavik Kansara
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Abstract
Herein disclosed are biorelevant dissolution media using a phosphonocholic acid salt in combination with a polysorbate. This tailor-made combination of surface-active agents apparently forms mixed micelles similar to those formed in the currently available biorelevant media, is faster and easier to prepare, forms reproducible and consistent dissolution media, and compares well with the predictive properties of currently available biorelevant dissolution media and thus is useful to predict the in vivo behavior of dosage forms of poorly water-soluble drugs.
Claims18
A biorelevant dissolution medium, comprising a micellar solution comprising a phosphonocholic acid salt that is a disodium salt of 23-phosphonocholic acid or of 24-phosphonocholic acid, a polysorbate, a buffer component and an osmotic agent;
- wherein the synthetic phosphonocholic acid salt and the polysorbate have a mole ratio between about 1:1 and 20:1.
Dependencies are inferred from the claim text.