Development and validation of in vitro-in vivo correlation (Ivivc) model for microparticulate lornoxicam loaded controlled release tablet

In vitro-in vivo correlation (IVIVC) is a powerful tool for determining the in vivo character-istics of modified release drug product. Lornoxicam is classified as BCS class II drug. The present research aimed to describe IVIVC of three different sustained-release lornoxicam tableted microparticles and immediate release tablet (Xika Rapid®8 mg). Lornoxicam loaded microspheres were prepared using modified emulsion solvent evaporation method and then formulated into tablet. In vitro characteriza-tions were done including dissolution study, SEM analysis and FTIR spectroscopy. A validated HPLC method was adopted to quantify lornoxicam in plasma sample post-bioavailability studies in twenty healthy young human volunteers. The percent cumulative drug released (in vitro) against the percent drug absorbed (in vivo) at specific time points was plotted and an excellent linear correlation for opti-mized formulations (R2 = 0.966, 0.981, 0.9846 for BF1, BF2, and control formulations, respectively). BF2 was observed closer to the control formulation that showed a reliable prediction of the plasma concentra-tions obtained following a single dose of lornoxicam controlled release formulation. The validated IVIVC model can be utilized for biowaiver studies of other BCS class II drugs.