How to establish level A IVIVC for BCS class II IR products where in vitro time points are not the same as in vivi time points?
SD: Mathematically, the different in vitro dissolution time points & in vivo absorption time points may be correlated using time-scaling parameters. However, some points about developing an IVIVC for an IR product should be noted: (1) IVIVC is applicable for extended release products where drug absorption is dissolution-rate limited; (2) in order to establish an IVIVC one would ideally require formulations that have sufficiently different release rates that result in different rates &/or durations of absorption. Although Class II compounds may have low solubility and therefore absorption may be dissolution-rate limited, the different “IR” formulations would all, theoretically, release drug within ~1 hour. Therefore, in vivo dissolution would be dependent largely on the drug molecule physico-chemical properties & not the formulation. Therefore, one would not expect to see sufficiently different absorption profiles that will permit the development of an IVIVC.
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