ABSTRACT
Objective:To prepare and optimize the formula of metoclopramide orally disintegrating tablets, and investigate the in vitro drug dissolution behavior. Methods:The formula was optimized by full-factorial experiment design, the ratio of mannotil to micro-crystalline cellulose ( X1 ) and the amount of disintegrating agent ( X2 ,%) were selected as the independent variables, and the friabili-ty ( Y1 ,%) , disintegration time ( Y2 , s) and metoclopramide dissolution ( Y3 ,%) were used as the dependent variables. The release rate of metoclopramide orally disintegrating tablets in different dissolution media was studied. Results:The optimum formula of meto-clopramide orally disintegrating tablets was as follows:the ratio of mannotil to microcrystalline cellulose was 2. 5∶ 1, and the amount of disintegrating agent was 6. 5%. The dissolution of metoclopramide orally disintegrating tablets in the different dissolution media was o-ver 80%. Conclusion:The formula design is reasonable, the preparation process is feasible and the quality can be controlled.
ABSTRACT
Objective:To compare the dissolution results of doxazosin mesylate extended release tablets determined by a fiber-optic method and the imported drug registration standard method. Methods:The drug release process was determined directly with a FODT-601 fiber-optic medicine dissolution/ release rate process monitoring system. Aqueous solution of hydrochloric acid and sodium chloride was used as the dissolution medium, the paddle rotation rate was 75 r·min-1 , the detection wavelength was set at 246 nm while the reference wavelength was 550 nm. The detection length was 5 mm. Results:The standard curve of doxazosin mesylate was linear within the concentration range of 0. 468 1-11. 700 0μg·ml-1 and r values were greater than 0. 999 0. The intra-and inter-day RSD (n=6) was 1. 6% and 2. 0%, respectively. The recovery of doxazosin mesylate was 99. 0% and RSD was 1. 4(n=9). The results determined by the fiber-optic method were generally higher than those determined by the standard method, and there were some differences in the measurement results. Conclusion:Fiber-optic method shows the whole dissolution process objectively. It is particularly prominent in the research on the dissolution of rapid, extended and controlled release preparations. However, it can not replace the standard method yet.