Preparation method of lutrombopag crystal form

The preparation of rutrombopag crystal form X using a polar solvent via a pulping method solves the problem of unstable preparation in existing technologies, achieving efficient and stable crystal form preparation and improving drug reproducibility and production efficiency.

CN121471167APending Publication Date: 2026-02-06CDMO PHARM CO LTD +1
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Patent Information

Application Number
CN202511354957.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-22
Publication Date
2026-02-06

AI Technical Summary

Technical Problem

Existing technologies cannot stably prepare the original crystal form X of rutrombopag, resulting in poor reproducibility and affecting the efficacy and toxic side effects of the drug.

Method used

Amorphous leucoboroppa was used as raw material. The crystals were transformed by using polar solvents such as acetone, acetonitrile, ethanol or methanol through a pulping method. The pulping temperature and time were controlled, and after separation and drying, leucoboroppa crystal form X was obtained.

Benefits of technology

Stable preparation of the crystalline form X of leucobronchial pompano was achieved, improving reproducibility, simplifying the operation process, and reducing time costs.

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Abstract

The invention relates to a preparation method capable of stably preparing a lutrombopag crystal form X. The preparation method comprises the following steps: (a) pretreating a lutrombopag crude product to obtain amorphous lutrombopag; (b) adding the amorphous lutrombopag into a pulping solvent for pulping; and (c) separating and drying to obtain the lutrombopag crystal form X, the prepared crystal form X has characteristic peaks at the positions of about 7.50 + / -0.2, 11.05 + / -0.2, 12.77 + / -0.2, 15.00 + / -0.2, 17.73 + / -0.2, 20.29 + / -0.2, 21.00 + / -0.2, 22.40 + / -0.2, 23.23 + / -0.2, 24.06 + / -0.2 and 25.43 + / -0.2.
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Citation Information

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