Objective  To use a flow-through cell to simulate the dissolution of mirabegron sustained-release formulations to establish an in vitro-in vivo correlation (IVIVC), and to delevolp an in vitro dissolution method with predictive ability.

Methods  The corresponding cumulative absorption fractions (F_abs%) were obtained by deconvolution of the in vivo plasma concentrations of the three different release rate formulations by the Loo-Riegelman method, and the in vitro dissolution target curve was established. The concentration of reference R (Betmiga^®, 50 mg) and test T1, T2, (50 mg) formulations in the dissolution test was determined by HPLC under the test conditions of pure water as the test medium and the flow rate of 4.0 mL·min^-1. The accumulated release fractions (F_diss%) of the formulation was obtained by the trapezoidal area method.

Results  A level A IVIVC (the coefficient > 0.9) of mirabegron sustained-release formulation between the absorption in vivo and dissolution in vitro was established. The external prediction error of the formulation was within the specified range.

Conclusions  The IVIVC model established in this study has been verified to have good predictive ability, and the good discrimination and linearity of this method can also provide a reference for quality control.

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