A Novel Intestine Model Apparatus for Drug Dissolution Capable of Simulating the Peristaltic Action.
A novel dissolution apparatus has been proposed as an alternative apparatus for dissolution testing. In this study, we evaluated the performance of the new intestine model for simulating the peristaltic action (IMSPA), generating the movement that closely mimics peristaltic contractions of the small intestine. Two polyethylene oxide matrix tablet formulations, containing a model drug belonging to class III of the Biopharmaceutics Classification System, were tested. Dissolution was also performed in the USP2 apparatus. The release profiles were further compared to the in vivo data to evaluate the in vivo relevance of the new apparatus. The results demonstrated that the novel apparatus showed good discriminatory power between different polyethylene oxide formulations. Moreover, a better relation to the in vivo data was established by the IMSPA as compared to the USP2 apparatus. In conclusion, the model parameters were efficiently controlled to ensure the dissolution conditions crucial for evaluating the in vivo release performance of the tested formulations.
Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000, Ljubljana, Slovenia. melita.hribar@sandoz.com.
Melita
M
Hribar
Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000, Ljubljana, Slovenia.
Jurij
J
Trontelj
Lek Pharmaceuticals d.d., Verovškova 57, 1526, Ljubljana, Slovenia.
Uroš
U
Klančar
Lek Pharmaceuticals d.d., Verovškova 57, 1526, Ljubljana, Slovenia.
Boštjan
B
Markun
Lek Pharmaceuticals d.d., Verovškova 57, 1526, Ljubljana, Slovenia.
Tanja
T
Čeligoj Dujc
Lek Pharmaceuticals d.d., Verovškova 57, 1526, Ljubljana, Slovenia.
Igor
I
Legen
D065546:Drug Liberation; D010528:Peristalsis; D011092:Polyethylene Glycols / Q000737:chemistry; D012995:Solubility; D013607:Tablets
D013607:Tablets; D011092:Polyethylene Glycols
dissolution testing; extended release; matrix tablets; polyethylene oxide (PEO); small intestine