ABSTRACT
Objective To compare the dissolution behavior between domestic trepibutone tablets and original reference product, and provide a basis for evaluating the quality consistency of generic drugs. Methods Four dissolution media recommended by Japanese Orange Book and a domestic standard dissolution media were selected to determined the dissolution profile,and f2 factor was calculated to investigate the consistency of stripping curves. Results In water,pH 4.0 and pH 1.2,the f2 of domestic formulation and reference formulation was under 50,and the dissolution profile was inconsistent.Dissolution behavior of domestic preparations of different manufacturers was dissimilar.In water,the f2 of domestic preparations of different batches of the same manufacturer was over 99.9,and the dissolution behavior was similar. Conclusion The dissolution method of existing domestic standard can not distinguish the dissolution behavior of different products,and it should be revised and completed.There is still great difference in quality between the domestic preparations and reference preparations.
ABSTRACT
Objective:To analyze and evaluate the degassing effect of vacuum degassing apparatus through the determination of ox-ygen content in pure water, gas pressure and air volume, and compare with suction filtration, boiling and ultrasonic methods to choose the appropriate degassing method for dissolution medium and guide the daily inspection work. Methods: The water residual oxygen, gas pressure and air volume were determined using a single water quality on-line monitoring instrument and a Carbo QC Anton Pear in-strument. The degassing effect of the vacuum degassing apparatus was detected under the conditions of negative pressure and certain de-gassing time. The degassing effect was also compared with that of suction filter, boiling and ultrasonic methods. Results: Under the conditions of 0. 06 MPa negative pressure, 41℃ medium temperature and 30 min degassing time, the degassing effect of the vacuum degassing apparatus was obvious. The degassing effect of suction filter and boiling methods was similar to that of the vacuum degassing apparatus, while that of ultrasonic method wasn't obvious. Conclusion:The use of vacuum degassing apparatus is simple and efficient with obvious degassing effect, which is suitable for the degassing process of dissolution medium.
ABSTRACT
Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot to lot quality of drug product. The development and validation of dissolution procedures is of paramount importance during development of new formulation and in quality control. The dissolution procedure must be properly developed and validated. The objective of this paper is to review the development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, limit of detection, limit of quantitation and robustness of methods. Developing and validating dissolution test procedures can be a challenging process, on multiple fronts. Methods must be developed and validated not just for the dissolution test procedure itself, but also for any assay used to evaluate the test results.