Investigation of the biopharmaceutical behavior of theophylline hydrophilic matrix tablets using USP methods and an artificial digestive system.
This work aimed to investigate the biopharmaceutical behavior of hydrophilic matrix tablets of theophylline using different in vitro methods: USP II, USP IV, and a novel in vitro system simulating the gastrointestinal tract in man called the artificial digestive system (ADS). The potentiality of each method was evaluated by establishing in vitro/in vivo correlation. Using USP methods, the drug release was pH-independent and dependent on agitation intensity. Level A IVIVCs could be established using the different in vitro methods but one to one correlation was established only when the ADS method was used. For the prediction of in vivo drug dosage form behavior based on in vitro methods, the ADS showed a high predictability when compared to USP in vitro methods.
Souliman
Sabah
S
Equipe de Recherche Technologique Conception, Ingénierie et Développement de l'Aliment et du Médicament (ERT CIDAM), Faculté de Pharmacie, Clermont-Ferrand, France.
Beyssac
Eric
E
Cardot
Jean-Michel
JM
Denis
Sylvain
S
Alric
Monique
M
D000284:Administration, Oral; D000328:Adult; D003692:Delayed-Action Preparations; D004386:Duodenum / Q000378:metabolism; D005544:Forecasting; D041981:Gastrointestinal Tract; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007082:Ileum / Q000378:metabolism; D007583:Jejunum / Q000378:metabolism; D008297:Male; D008954:Models, Biological; D012995:Solubility; D013314:Stress, Mechanical; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013806:Theophylline / Q000737:chemistry / Q000493:pharmacokinetics*
D003692:Delayed-Action Preparations; D013607:Tablets; D013806:Theophylline