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The  ex vivo  isolated perfused rat lung (IPL) model has been demonstrated to be a useful tool during drug development for studying pulmonary drug absorption. This study aims to investigate the potential use of IPL data to predict rat  in vivo  lung absorption. Absorption parameters determined from IPL data ( ex vivo  input parameters) in combination with intravenously determined pharmacokinetic data were used in a biopharmaceutics model to predict experimental rat  in vivo  plasma concentration-time profiles and lung amount after inhalation of five different inhalation compounds. The performance of simulations using  ex vivo  input parameters was compared with simulations using  in vitro  input parameters, to determine whether and to what extent predictability could be improved by using input parameters determined from the more complex  ex vivo  model. Simulations using  ex vivo  input parameters were within twofold average difference (AAFE < 2) from experimental  in vivo  data for all compounds except one. Furthermore, simulations using  ex vivo  input parameters performed significantly better than simulations using  in vitro  input parameters in predicting  in vivo  lung absorption. It could therefore be advantageous to base predictions of drug performance on IPL data rather than on  in vitro  data during drug development to increase mechanistic understanding of pulmonary drug absorption and to better understand how different substance properties and formulations might affect  in vivo  behavior of inhalation compounds.

Drug Absorption Parameters Obtained Using the Isolated Perfused Rat Lung Model Are Predictive of Rat In Vivo Lung Absorption