Combined models for data from in vitro-in vivo correlation experiments.
A method is presented to describe the in vitro-in vivo correlation (IVIVC) of an extended release drug formulation. This extended release drug product is overencapsulated with immediate release material. The heterogeneity of the capsule is modelled using a combined model of an extended release and an immediate release pharmacokinetic profile. Whereas an IVIVC is conventionally performed using a two-stage procedure, the model uses a one-stage convolution-based method. The method is applied to a Galantamine controlled release formulation, an acetylcholinesterase inhibitor for the treatment of Alzheimer's disease. The average percentage prediction error indicated a good fit of the new model.
Jacobs
Tom
T
Interuniversity Institute for Biostatistics and Statistical Bioinformatics, University Hasselt, Diepenbeek, Belgium. tom.jacobs@uhasselt.be
Rossenu
Stefaan
S
Dunne
Adrian
A
Molenberghs
Geert
G
Straetemans
Roel
R
Bijnens
Luc
L
D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002800:Cholinesterase Inhibitors / Q000737:chemistry / Q000493:pharmacokinetics*; D003692:Delayed-Action Preparations; D005702:Galantamine / Q000737:chemistry / Q000493:pharmacokinetics*; D006801:Humans; D008954:Models, Biological; D008956:Models, Chemical; D015233:Models, Statistical; D015203:Reproducibility of Results; D012995:Solubility
D002214:Capsules; D002800:Cholinesterase Inhibitors; D003692:Delayed-Action Preparations; D005702:Galantamine