Acta poloniae pharmaceutica

In vitro to in vivo profiling: an easy idea for biowaiver study.

PMID 24147366


The aim of this article was to assess and apply the in vitro to in vivo profiling (IVIVP), a new biowaiver approach, in designing a product with specific release pattern. The IVIVP was established by plotting the observed and predicted plasma drug concentrations. For IVIVP, convolution approach was employed to estimate plasma drug concentrations from in vitro dissolution profiles. The IVIVP for T1S exhibited a good correlation coefficient (R2 = 0.963) followed by the T2 (R2 = 0.682), T3 (R2 = 0.665), T1 (R2 = 0.616), and Mepresso (R2 = 0.345). Establishing an IVIVP, based on the convolution approach, can be more useful and practicable in the biowaiver studies, rather than present not useful practice of IVIVC estimated via deconvolution approach. This paper also elaborates that there is good correlation between the in vitro and in vivo profiles of the developed metoprolol tartrate formulations, particularly for T1S.