Topiramate, orlistat new crystalline form and preparation method

2015 
The present invention belongs to the pharmaceutical field of chemical technology, specifically to a new crystalline topiramate, orlistat type which X- ray powder diffraction pattern characteristic peaks at 2θ 5.38 ± 0.2,8.29 ± 0.2,10.78 ± 0.2,15.46 ± 0.2,21.59 ± 0.2,26.88 ± 0.2 degrees. This crystalline form has good thermal stability and humidity stability and high solubility, and high product purity, is very suitable for long-term storage, is more suitable for preparing solid formulations having good dissolution and / or stability. The present invention also provides a preparation method: the orlistat topiramate was added to the organic solvent, a base is added, a clear solution was stirred until the solid was added active carbon, filtered and the filtrate was added dropwise the acid, the pH was adjusted to 6-7 with solid precipitate, filtered off with suction, the filter cake was rinsed, dried, topiramate, orlistat to obtain the new polymorph. The method of preparing a crystalline form of a single product, a stable, very suitable for industrial production.
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