Media for Immediate Release dosage

[PKR]

The most routine IR (immediate release) dissolution media seems to be 0.1 or 0.01 N HCl. Has anyone used phosphate or acetate buffered media for such IR dosage form dissolution experiments? If these sorts of buffers have been used, (a) what buffer concentrations have been used?, and (b) has anyone had regulatory success with such a system?

[Leevis]

We have used Phosphate and Citrate media in the past. We follow USP suggestions around concentrations (the suggested buffers sections) and keep close to 0.05 M. Sometimes using 0.1M.

Lee

[douglasgm]

We have used both phosphate and acetate buffers in the past for IR products. They have been acceptable as long as the solubility and stability data for the drug support the choice of media.

[amol]

Yes of course we do use salts in the dissolution media such as acetate and phosphate buffers. The use of simulated gastric fluids and simulated intestinal fluids are wellnown as dissolution buffers. Only thing is that for regulatory approval we need to validate these methods same as in case of compendial methods. :cool:

[ashwanijoy]

Intrinsic dissolution is done on media,in which drug is freely soluble.
Same media is kept for immediate release.

[ashwanijoy]

:confused:
Why dissolution of captopril tablets is always on higher side ,even though method is USP. and no overage is taken in drug formulation.

[ashwanijoy]

:rolleyes:

If we r using water as medium what is ideal pH accepted to regulatory bodies.