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The following message was posted to: PharmPK
Dear David sir,
I have gone through your web site boomer.org, the courses you are
and the syllabus covering is very good and excellent.
Sir I am facing one problem in deciding the dissolution profile of a
which is currently available as immediate release in the market, but
is administred 2-3 times daily, we are in a process of developing its SR
During developmet stages how can we extrapolate the pharmacokinetic
IR dosage form (AUC, Cmax, Tmax, T1/2, Kel, Ka and other) in deciding SR
dissolution profile. So that when biostudy is carried out, the plasma
concentration will be within therapeutic range. Considering the IR dose,
how can we decide the SR dose for required period.
If you have any software to help out above developmet, we can buy that
Your kind guidance is most precious for me.
Thanks and Regards,
Wockhardt Research Center,
D-4, MIDC, Chikalthana Industrial Area,
Ph: 0091 240 - 2482590,
0091 240 - 2485498,
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I dont think it is easy to use pharmacokinetic data of IR to
extrapolate for SR. I have a suggestion though. Since SR is an
"equivalent" of multiple doses, i would suggest you look at the
multiple doses PK, apart from some other factors (such as solubility,
pKa, and other physical factors) that may affect the formulation of
your drug into the SR form. The multiple dose, and also the
intravenous infusion data (if available), will give you a rough idea
of the steady state concentrations and from that, you may be able to
work back on the dose etc for SR.
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