title: [Improvement of dissolution test using micro-controlled roller pump].
abstract: The dissolution test is a core performance test in pharmaceutical development and quality control of solid drug products. The conventional HPLC dissolution method (batch-sampling method) involves many steps including the filtration, collection and replenishment of sample solutions. We previously reported a dissolution test that involved microdialysis methods (microdialysis-HPLC method) and allowed many steps to be omitted. However, the recovery rate of theophylline by the microdialysis-HPLC method was lower, and the decrease in the flow rate through the dialysis probe caused variation between each tablet. In this study, we have attempted to improve the dissolution test by using a precise micro-controlled roller pump and microfiltering probe (microfiltering-HPLC method). Sustained release preparations of Theodur (100 mg) were used, and the test solutions used were water, buffer at pH 1.2 and pH 6.8, and pH 6.8-buffer containing 0.1-1% polysorbate 80 or sodium lauryl sulfate. In all test solutions, the microfiltering-HPLC method was able to accomplish continuous sampling of sample solutions, and the recovery rate of theophylline was over 90%. The dissolution behavior by the microfiltering-HPLC method tends to reflect the pharmaceutical design in comparison with the batch-sampling method, and the standard deviations by the microfiltering-HPLC are lower than with the batch-sampling method. In addition, the microfiltering-HPLC method allows many steps to be omitted, such as the filtration, collection and replenishment of sample solutions. These findings provide significant information that can be used in the pharmaceutical development and quality assessment of solid drug products.
authors.affiliation: School of Pharmacy, Kinki University, Osaka, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Nagai
authors.forename: Nahoko
authors.initials: N
authors.lastname: Konishi
authors.forename: Tadahisa
authors.initials: T
authors.lastname: Nitta
authors.forename: Atsushi
authors.initials: A
authors.lastname: Taga
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Ito
mesh_terms: D002021:Buffers; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003692:Delayed-Action Preparations; D006863:Hydrogen-Ion Concentration; D008851:Micropore Filters; D012995:Solubility; D012996:Solutions; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013806:Theophylline; D014867:Water
chemical_list: D002021:Buffers; D003692:Delayed-Action Preparations; D012996:Solutions; D013607:Tablets; D014867:Water; D013806:Theophylline