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while the PK profi le predicted on the basis of the CR tablets dissolution in
water indicated slow and incomplete drug absorption. It was noted that
such results were in accordance with the software calculated 39.29 h to be
the time needed for 100% drug dissolution to be accomplished, which
exceeds the physiologically relevant GI transit time.
In order to develop a level A IVIVC, CBZ plasma concentration profi les
simulated on the basis of drug dissolution data obtained in water and
media containing 1% SLS for IR and CR tablets (Figure 6.15) were
plotted against the in vivo observed data. Linear regression analysis of
the pooled data for both the generic and reference IR and CR tablets
indicated high level A IVIVC, especially for predictions based on the in
vitro data observed in 1% SLS (Figure 6.16). According to these results,
it was suggested that 1% SLS might be considered as the 'bioperformance'
dissolution medium for both the IR and CR CBZ tablets. However, it was
noted that the possibility to obtain a universal IVIVC model for both IR
and CR products resulted from the fact that CBZ in vivo behavior is
determined by its PK characteristics (i.e. long elimination half-life) rather
than the dosage form properties, and that any further generalization of
this concept to other compounds should be carefully evaluated.
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Comparative dissolution data for generic (dotted line)
and reference (solid line) CBZ tablets in water
(triangle) and 1% SLS (circle) (open symbols refer to
CR tablets, closed symbols refer to IR tablets)
Figure 6.15
 
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