| 摘要 |
The present invention relates to a novel glyceryl phosphoryl choline crystal and a preparation method therefor. With respect to the preparation of the glyceryl phosphoryl choline crystal of the present invention, a novel crystal can be obtained by controlling the crystal precipitation temperature and the stirring time in the solvent environments, and a preparation process is simple compared with a conventional method by not requiring a seeding step. It was ascertained that the crystal of the present invention is a stable solid form in which the melting temperature is 100°C or higher and there is no thermodynamic aging through the analysis result of thermal stability and crystal polymorphism, and thus the crystal is very pharmaceutically useful. In addition, the crystal possesses an excellent hygroscopicity profile from hygroscopicity test results, the bulk density (BD) and the tap density (TD) exhibit values suitable for preparing a dosage form, and the particle distribution degree is very uniform and has symmetric characteristics of a normal distribution, and thus the formulation is simple. The glyceryl phosphoryl choline crystal (form III or IV) of the present invention can be used as a dementia therapeutic agent which is a nootropic agent. |
