Dissolution is the step of rate determination for the poorly aqueous soluble drug and hydrophobic molecules.
As per the USP a drug product is believed to quickly dissolve when no less than the 85% of the claim amount of the molecule dissolve within the 30 minutes, by using USP apparatus-I on 100 RPM or 50 RPM for USP apparatus-II, into a 900 ml volume or less in all of the media, like 0.1 n HCl, a pH 4.5 buffer, pH6.8 buffer.
Dissolution rate equation
dw/dt= ks (Csat-Csol)
Where
dw/ dt = are dissolution rate
k = a dissolution constant
S = surface area of the solid
C sat = the concentration of a saturated solution
C sol = the concentration at any given time
You may also like this
As per the USP a drug product is believed to quickly dissolve when no less than the 85% of the claim amount of the molecule dissolve within the 30 minutes, by using USP apparatus-I on 100 RPM or 50 RPM for USP apparatus-II, into a 900 ml volume or less in all of the media, like 0.1 n HCl, a pH 4.5 buffer, pH6.8 buffer.
Dissolution rate equation
dw/dt= ks (Csat-Csol)
Where
dw/ dt = are dissolution rate
k = a dissolution constant
S = surface area of the solid
C sat = the concentration of a saturated solution
C sol = the concentration at any given time
You may also like this
No comments:
Post a Comment