[The solubility and in vivo-in vitro correlation of naltrexone]

The dissolution of three dosages of Naltrexone tablets was studied, there being no monograph of this active principle in the most commonplace pharmacopoeia. The dissolution parameters were calculated "in vitro", then a correlation model was applied to determine the relationship between these parameters and the "in vivo" pharmacokinetic parameters of Naltrexone at each dosage level and also their degree of association. The regression lines between the "in vivo" and "in vitro" parameters were then plotted. Three C level correlations were obtained as per USP 23 between the pharmacokinetic parameter Cmax and the dissolution parameters 1/T50, E.D.30 and kd. The dissolution test conditions were also validated.