Information Technology Reference
In-Depth Information
CBZ IR (a-d) and CR tablets (e, f) dissolution profi les
in various dissolution media and the corresponding
simulated
in vivo
profi les (open square symbols refer
to the actual
in vivo
data (f))
Figure 6.14
did not appear to be strongly affected by the differences in drug dissolution
rate. The best match between the predicted and the observed C
max
and
AUC values was accomplished for drug dissolution in 0.5 and 1% SLS.
An interesting phenomenon concerned the deviations between the
predicted C
max
and t
max
values obtained for different pH dissolution media
(water, media pH 1.2, 4.5, and 6.8), which were not consistent with the
almost superimposable
in vitro
dissolution profi les in these media
(Figures 6.14c and d). It was postulated that the obtained differences were
caused by a simulation artifact resulting from the software approximation
of the time needed to accomplish 100% drug dissolution, which was
estimated as 5.5 and 15.4 h for water and pH 6.8 media, respectively. In
the case of CR tablets, the simulated profi les based on CBZ dissolution in
1% SLS and HCM were in best agreement with the
in vivo
observed data,
Search WWH ::
Custom Search