Novel crystal form of benzothiazepine derivative compound and preparation method thereof

Novel crystal forms of benzothiazepine derivatives address stability and hygroscopicity issues, providing enhanced stability and solubility for effective drug treatment of various conditions.

WO2026139908A1PCT designated stage Publication Date: 2026-07-02HK INNO N CORP

Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
HK INNO N CORP
Filing Date
2025-12-24
Publication Date
2026-07-02

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Abstract

The present invention relates to a novel crystal form of a benzothiazepine derivative compound and a preparation method thereof. The crystal form of the present invention may show solubility which may be used for an active pharmaceutical ingredient and has excellent stability against heat and moisture, and thus may be stably preserved without being decomposed even during a long-term storage. In addition, according to the present invention, the crystal form of ((3,3-dibutyl-5-(4-fluorophenyl)-7-(methylthio)-1,1-dioxido-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-8-yl)methyl)glycine may be easily prepared through a simple process, thereby facilitating mass-production and enabling economic feasibility, and may be used as a pharmaceutical raw material of drugs prepared in various formulations. The crystal form of the present invention may have physical properties advantageous for the preparation of drugs and may be effectively used in the prevention or treatment of constipation, non-alcoholic fatty liver disease, dyslipidemia, progressive familial intrahepatic cholestasis (PFIC), alagille syndrome, or biliary atresia.
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