Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses.
In order to improve the predictability of dissolution testing new apparatuses have been proposed that mimic hydrodynamic and mechanical conditions in the gastrointestinal tract. In this study tested were four different nifedipine extended release (ER) formulations using the paddle apparatus and the reciprocating cylinder as pharmacopoeial test devices as well as two newly developed test apparatuses: the rotating beaker apparatus and the dissolution stress test apparatus. Investigated were Adalat OROS in strengths of 30 and 60 mg, and two hydrophilic matrix formulations: 60 mg nifedipine Coral and Nifedipin Sandoz 40 mg retard. The results demonstrate that the dissolution characteristic of the ER tablets is strongly dependent on the applied test conditions. The dosage form related food effects for Coral 60 mg tablets that were previously observed in human bioequivalence studies could be predicted with the two non-compendial dissolution test devices. The dissolution of Sandoz 40 mg tablets was very sensitive to all applied test conditions. The stable drug delivery characteristics of Adalat OROS observed in numerous in vivo studies was also observed in all of the dissolution tests. In conclusion, the present study shows that besides pH dependency the aspect of the mechanical robustness may be an essential factor affecting the dissolution characteristic of hydrogel matrix formulations.
Garbacz
Grzegorz
G
Department of Biopharmaceutics and Pharmaceutical Technology, Institute of Pharmacy, University of Greifswald, Friedrich-Ludwig-Jahn-Strasse 17, 17487 Greifswald, Germany. grzegorz.garbacz@uni-greifswald.de
Golke
Berit
B
Wedemeyer
Ralph-Steven
RS
Axell
Marie
M
Söderlind
Erik
E
Abrahamsson
Bertil
B
Weitschies
Werner
W
D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D009543:Nifedipine / Q000008:administration & dosage / Q000737:chemistry*; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D009543:Nifedipine