反应详情
EQUATION
反应方程式
REACTANTS
反应物
PRODUCTS
生成物
AUXILIARIES
试剂、催化剂与溶剂
PROCEDURE
实验过程
Dissolution over time of 3 mg eszopiclone maleate tablets at physiological temperature (37° C.) was tested in dissolution media at various pH values using Hanson Research SR8-Plus Dissolution Apparatus and C-Technologies Fiber Optic UV Probes at 305 nm (excipients subtracted at 410 nm). The dissolution media used were (a) pH 1 0.1N HCl prepared by mixing 50 mL of conc HCl in 6 L of water; (b) pH 4.5 acetate buffer (20 mM) prepared by dissolving 5.88 g of sodium acetate trihydrate in 6 L of water and adjusting the pH to 4.5 with acetic acid; (c) pH 5.5 phosphate buffer (20 mM) prepared by dissolving 16.3 g of potassium dihydrogen phosphate in 6 L of water and adjusting the pH to 5.5 with NaOH; (d) pH 6.8 phosphate buffer (20 mM) prepared by dissolving 16.3 g of potassium dihydrogen phosphate in 6 L of water and adjusting the pH to 6.8 with NaOH. A standard dissolution protocol was used. The standard solution (0.006 mg/mL of eszopiclone free base) was prepared by weighing a known amount (˜20 mg) of the free base into a 100 mL volumetric flask. About 10 mL of acetonitrile was added into the flask and sonicated until the solids dissolved completely. The solution was cooled to room temperature and made up to the 100 mL mark using media and mixed well. From this stock solution, 3 mL was diluted to 100 mL using media. A volume of 500 mL of the dissolution medium is transferred to each of the 6 vessels in the dissolution apparatus and warmed to a temperature of 37° C. The Fiber Optic probes are immersed in each of the dissolution vessels and readings for the blank are taken for all the probes in the dissolution media. The readings for the standard are recorded for each of the individual vessels. The probes are then washed with the media and then inserted back into their respective vessels. One tablet was transferred into each vessel. The dissolution program was started immediately and readings were taken at 305 nm for 60 min (every 1 min for 20 min and then every 10 min). The dissolution profiles of 3 mg eszopiclone maleate tablets are shown in FIG. 2.
WORKUP
后处理
- dissolutionwas tested in dissolution media at various pH values
- dissolutionHanson Research SR8-Plus Dissolution Apparatus and C-Technologies Fiber Optic UV Probes at 305 nm (excipients subtracted at 410 nm)
- dissolutionThe dissolution media
- customprepared
- customsonicated until the solids
- dissolutiondissolved completely
- additionmixed well
- additionFrom this stock solution, 3 mL was diluted to 100 mL
- temperaturewarmed to a temperature of 37° C
- dissolutionof the dissolution vessels and readings for the blank
- dissolutionin the dissolution media
- washThe probes are then washed with the media
- customOne tablet was transferred into each vessel
- wait(every 1 min for 20 min
- customevery 10 min
- dissolutionThe dissolution profiles of 3 mg eszopiclone maleate tablets