[Improvement of dissolution test using microdialysis method].
Dissolution testing is a core performance test in pharmaceutical development and quality control. Generally, the HPLC method uses the analysis of dissolution testing. In this study, we attempted to improve the dissolution test by using microdialysis methods. We also investigated the comparison of the conventional HPLC dissolution method (batch-sampling method) and the improved dissolution test (microdialysis method). Histamine H(2)-receptor antagonist cimetidine tablets (200 mg), which are used clinically and of which there are also some generic examples, were selected for this comparison, and the dissolution behavior of the tablets by the two methods were found to be similar. On the other hand, standard deviation in the microdialysis method was lower than that of the batch-sampling method. In addition, the microdialysis method can omit many steps such as the filtration, collection and replenishment of sample solutions, and is also able to accomplish continuous sampling of sample solutions. These findings provide significant information that can be used in the pharmaceutical development and quality control of original and generic products.
Nagai
Noriaki
N
School of Pharmacy, Kinki University, Higashi-Osaka, Japan.
Murao
Takatoshi
T
Ito
Yoshimasa
Y
D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002927:Cimetidine; D016568:Drugs, Generic; D006863:Hydrogen-Ion Concentration; D017551:Microdialysis / Q000379:methods*; D011786:Quality Control; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*
D016568:Drugs, Generic; D013607:Tablets; D002927:Cimetidine