Stable crystalline form I agomelatin tablet and method for its preparation

摘要

Disclosed are stable crystalline Form I agomelatin tablets and methods for their preparation. The preparation method is: adding one or more protective agents in pure water, stirring, heating the mixture to 35-40 ° C., dissolving them until the solution is clear, cooling the solution to room temperature, Adding crystalline Form I agomelatine and stirring the mixture until homogeneous to obtain a protective agent containing crystalline Form I agomelatin; then mixing a portion of the pharmaceutical additive until uniform, forming crystalline Form I Re-adding protectants containing agomelatine, mixing and pelleting them according to the wet method, drying to obtain particles containing crystalline Form I agomelatine; and finally, other pharmaceutical additives according to a proportion Adding into the particles, mixing them until uniform and tableting them. [Selection figure] None